Stroke

Stroke

Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY)

Purpose of the Study: This study is being completed to determine the safety and tolerability of 3KA-APC, a recombinant variant of human-activated protein C (APC), in combination with tissue plasminogen activator (tPA) in moderately severe acute hemispheric stroke.


Description: This is a multicenter, prospective, randomized, controlled, double-blinded, phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 100 subjects will be randomized. This study will utilize a modified version of the continual reassessment method (CRM) to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through day 7 (or discharge, if earlier) and are expected to be seen on day 7, 14, 30 and 90 for safety and outcome evaluations.


Eligibility Criteria: Men and women age 18 to 90 years who have experienced an acute ischemic stroke and are able to receive IV tPA, a mechanical thrombectomy or both. Participants will be excluded if they have a history of stroke or penetrating head injury within 90 days prior to enrollment, or a history of previous or current diagnosis of intracranial hemorrhage. Participants will also be excluded if they have Moyamoya disease, a cerebral arteriovenous malformation (AVM), a known unsecured aneurysm, prolonged prothrombin time, or severe hypertension or hypotension.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD, MPH


Contact:
Nirav Patel, Clinical Research Coordinator
Email: nirav.patel@osumc.edu


Funding: ZZ Biotech, LLC

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

Purpose of the Study: The risk of secondary stroke is greatest up to 90 days after transient ischemic attack (TIA) or minor ischemic stroke. This study is being done to determine whether plavix and aspirin is more effective at preventing strokes and heart attacks at 90 days than aspirin alone.


Description: TIAs are common and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the United States. The Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial is a prospective, randomized, double-blind, multicenter trial to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day. Each subject is followed for 90 days from randomization; the trial will be completed in 7 years. A total of 5,840 patients will be recruited.


Eligibility Criteria: Men and women over 18 years of age with high-risk TIA (ABCD2 score greater than or equal to 4) or minor ischemic stroke (NIHSS less than or equal to 3) who can be treated within 12 hours of time last known free of new ischemic symptoms will be enrolled. Participants must be able to tolerate aspirin at a dose of 50-325 mg/day. Participants with hemorrhage or other pathology, such as vascular malformation, tumor or abscess, will be excluded.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD


Contact:
Laura Buchwalder, Clinical Research Assistant
Email: Laura.Buchwalder@osumc.edu


Funding: NIH

Stroke Hyperglycemia Insulin Network Effort (SHINE)

Purpose of the Study: Studies have suggested that keeping tight control over glucose may lead to better outcomes. This trial is being conducted to determine if tighter glucose control (80-130 mg/dL) leads to better outcomes. Treatment is given over 90 days, and patients are randomized to either intravenous insulin or subcutaneous insulin.


Description: The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized and controlled clinical trial of 1,400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and will result in improved 3-month outcome after stroke. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - intravenous insulin with target 80-130 mg/dl) versus control therapy of subcutaneous insulin plus basal insulin with target glucose less than 180 mg/ dL.


Eligibility Criteria: Men and women 18 years or older. Eligible subjects must be within 12 hours of stroke symptom onset and have type 2 diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. Patients will be excluded if they have type 1 diabetes or substantial pre-existing neurological or psychiatric illness or if they are pregnant or breast-feeding at the time of study entry.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD, MPH


Contact:
Muhammdd Nasir, Clinical Research Coordinator
Email: Muhammad.Nasir@osumc.edu


Funding: NIH

Acute Stroke or Transient IsChemic Attack Treated With Aspirin or Ticagrelor and Patient OutcomES (SOCRATES)

Purpose of the Study: The risk of secondary stroke is greatest up to 90 days after transient ischemic attack (TIA) or minor ischemic stroke. This study is being done to determine if a drug called Ticagrelor is more effective than aspirin at preventing future strokes and heart attacks in patients with TIA or minor ischemic stroke over 90 days.


Description: The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) versus acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction and death) in patients with acute ischemic stroke or TIA.


Eligibility Criteria: Men and women 40 years and older with either acute ischemic stroke or high-risk TIA. Participants will be excluded for planned use of antithrombotic therapy in addition to study medication including antiplatelets and anticoagulants.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD


Contact:
Laura Buchwalder, Clinical Research Assistant
Email: Laura.Buchwalder@osumc.edu


Funding: AstraZeneca

Trevo® Retriever Registry

Purpose of the Study: To assess real world performance of the FDA cleared/CE marked Trevo Retriever intended to restore neurovasculature blood flow by removing thrombus in patients experiencing ischemic stroke.

Description:
The Trevo Retriever is a mechanical neuro-thrombectomy device. Results from the TREVO and TREVO 2 trials demonstrate revascularization efficacy and safety of the Trevo Retriever. The Trevo registry will assess the performance of the Trevo Retriever in real world practice which helps to increase understanding of its performance, to evaluate safety outcomes and to obtain information for potential improvements for next generation devices.

Eligibility Criteria: Patients with acute ischemic stroke who are eligible for restoration of blood flow using a Trevo Retriever, are able to provide written consent, willing to comply with the protocol follow-up requirements and have an anticipated life expectancy of at least 3 months. Patients participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point are not eligible.

Study Status: Open to accrual

Principal Investigator: Ciaran J. Powers, MD, PhD

Contact: Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

Funding/Study Sponsor: Stryker Neurovascular

WingspanTM Stent System with GatewayTM Percutaneous Transluminal Angioplasty Balloon Catheter

Official Title:  The WingspanTM Stent System with GatewayTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, an FDA-Designated Humanitarian Use Device (HUD; HUD #03-0101) Approved for Human Device Exemption (HOE; HOE 1050(01) (Stryker Corp.)


Description: Blood vessels narrow as cholesterol fatty deposits, calcium, and other elements accumulate, reducing the flow of blood, which carries oxygen and nutrients to tissue. In the brain, the reduction caused by a vessel's narrowing can cause mild to severe headaches and other symptoms; blocked flow can cause stroke and death.

In patients with stroke history and with disease of the blood vessels in the brain that has caused restriction of the vessels by 50% or more, treatment options are very limited. Without treatment, the natural history of such atherosclerotic disease of the blood vessels is abysmal. Treatment with drugs is possible in some patients, but when their disease does not respond to drug therapy, only one alternative treatment is now available in select patients.

The WingspanTM Stent System and GatewayTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter system is the only viable option for treating patients with this degree of vessel blockage. Because of its unique status for treating such a small population of patients, the United States Food and Drug Administration (FDA) approved it as a humanitarian use device (HUD) in January 2004. To make it immediately available for use in these patients, the FDA gave the system its humanitarian device exemption (HDE) in August 2005.

The Wingspan™ system offers select patients with severe atherosclerotic disease a safe and effective treatment to improve circulation within blood vessels seriously compromised by disease. The treatment is particularly appealing because it does not require opening of the skull. Potential benefits to patients receiving this treatment include prolonged and functional life, relief from the anxiety associated with this condition, and usefulness to society.

 

Eligibility Criteria: Use of the WingspanTM system is indicated in select patients with 50% or greater narrowing of blood vessels in the brain that cannot be improved using drug therapy and whose affected vessels are accessible to the system. Because this condition does not generally occur in children, all patients are expected to be adults 18 years or over.

Study Status: Open


Principal Investigator: Ciaran J. Powers, MD, PhD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

Hemorrhage

Hemorrhage

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)

Purpose of the Study: Currently there are no guidelines for blood pressure control in intracerebral hemorrhage (ICH) patients. This study is being done to see if intensive blood pressure control (>140 mmHg) compared to standard blood pressure (>180 mmHg) reduces the amount of death and disability in ICH stroke patients. All patients receive intravenous nicardipine for 24 hours.


Description: ATACH-II is a five-year, multi-center, randomized, controlled, phase-III trial to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with spontaneous supratentorial ICH. The primary hypothesis of this large focused trial is that intensive systolic blood pressure (SBP) reduction using intravenous (IV) nicardipine, with treatment initiated within three hours of onset of ICH and continued for the next 24 hours, reduces the likelihood of death or disability at three months after ICH by 10 percent or greater compared with standard SBP reduction. ATACH-II will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria.


Eligibility Criteria: Men and women 18 years and older for whom intravenous nicardipine can be initiated within 4.5 hours of stroke symptom onset. Participants will be excluded if their intracerebral hemorrhage is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms, or if it is located in infratentorial regions such as pons or cerebellum. Participants will also be excluded if their intracerebral hematoma is considered to be related to trauma, if they are currently pregnant, lactating, have used dabigatran within the past 48 hours, or have a known sensitivity to nicardipine.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD, MPH


Contact:
Nirav Patel, Clinical Research Coordinator
Email: nirav.patel@osumc.edu


Funding: NIH

Intracerebral Hemorrhage Deferoxamine Trial (iDEF)

Purpose of the Study: Currently there is no treatment for removal of iron from the brain after intracerebral hemorrhage (ICH). Iron is highly toxic and can lead to a host of issues including swelling and inflammation. This study is being done to determine if Deferoxamine is safe and effective at removal of the iron and leads to better outcomes in ICH patients.


Description: This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase II clinical trial. Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a maximum daily dose of 6000 mg/day), or saline placebo given by intravenous infusion for 3 consecutive days. All subjects will be followed for 6 months and will receive standard-of-care therapy while participating in the study. Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months will be compared to the placebo proportion.


Eligibility Criteria: Men and women aged 18 to 80 years old with a diagnosis of ICH confirmed by brain CT scan and a NIHSS score ≥6 and Glasgow Coma Scale score >6 upon presentation. Participants will be excluded if they have a planned surgical evacuation of ICH prior to administration of study drug or a suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis, or a variety of other factors.


Study Status: Open to enrollment


Principal Investigator: Michel Torbey, MD, MPH


Contact:
Carly Pouttu, Clinical Research Assistant
Email: Carly.Pouttu@osumc.edu


Funding: Beth Israel Deaconess Medical Center

Aneurysm

Aneurysm

CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System

Description: The CODMAN ENTERPRISETM Vascular Reconstruction Device and Delivery System is authorized by the Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥ 3 mm and ≤ 4 mm. Wide-neck is defined as having a neck width ≥ 4mm or a dome-to-neck ratio   < 2. The effectiveness of this device for this use has not been demonstrated. Stent placement in combination with coiling may provide unique opportunities to treat wide-neck intracranial aneurysms by offering the potential for treatment without compromising the parent artery lumen and preventing coil herniation into the parent vessel. Stent placement across the aneurysm neck may serve two functions. First, it attempts to restore the blood flow through the parent artery lumen while excluding the aneurysm sac. Second, stents may serve as a scaffold for coils to prevent herniation into the parent vessel and provide durable protection of the parent vessel. Use of the CODMAN ENTERPRISETM Vascular Reconstruction Device and Delivery System may help to hold the coils in place so there is less chance of a coil(s) moving from the aneurysm into the artery than if the stent was not used.


Eligibility Criteria: Patients eligible to undergo vascular reconstruction with the CODMAN ENTERPRISETM Vascular Reconstruction Device and Delivery System are those with angiographically documented wide-neck, intracranial, saccular or fusiform aneurysms, either ruptured or unruptured, who are deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization, and whose aneurysms arise from a parent vessel with a diameter of ≥ 3 mm and ≤4 mm. There are no age or gender restrictions. The CODMAN ENTERPRISETM Vascular Reconstruction Device and Delivery System has not been studied in women who are pregnant or lactating, and therefore pregnant or lactating women will not be included in the eligible population.


Study Status: Open


Principal Investigator: Ciaran J. Powers, MD, PhD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

Purpose of the Study: This trial is being conducted to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (standard diameter coil). The study lead’s hypothesis is that angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.


Description: FEAT will be a prospective, randomized trial comparing the utilization of 0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The 0.014-0.0155" bare platinum coils are FDA-approved and in common use at institutions in this country and around the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at their first and second follow-up visits.


Eligibility Criteria: Men and women aged 18 to 80 years with ruptured or unruptured cerebral aneurysm 6-14 mm in size that is appropriate for endovascular treatment as determined by the neurovascular treating team and that has not been previously treated by coiling or clipping.


Study Status: Open to enrollment


Principal Investigator: Ciaran Powers, MD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

Funding: Vanderbilt University

Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

Purpose of the Study: This study is being done to test the effectiveness of the HydroCoil Embolization System—a new generation FDA-approved device for treating aneurysms—compared to the current standard device for endovascular aneurysm treatment, which is bare platinum coils.


Description: 600 subjects from multiple institutions will take part in this study. Participation in this trial will last up to 24 months and will involve 6 visits (1 baseline visit before surgery, the surgical procedure and 4 follow-up visits). These visits will occur at the same time as the visits you would receive as standard-of-care after your surgery. Members of the control group, will have their aneurysm treated by the bare platinum coils during their endovascular procedure. Members of the study group will receive coils from the HydroCoil Embolization System. Both groups will receive the same standard-of-care and follow-up, but during the surgery different types of coils will be used.


Eligibility Criteria: Men and women aged 18 to 75 years with untreated intracranial saccular aneurysm 3-14 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils. Participants will be excluded if their aneurysm is not saccular in nature, has been previously clipped or coiled, or is in the physician's estimate unlikely to be successfully treated by endovascular techniques.


Study Status: Open to enrollment


Principal Investigator: Ciaran Powers, MD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu


Funding: Northwestern University

MicroVention Low-profile Visualized Intraluminal Support (LVIS®) or LVIS Jr. Humanitarian Use Device (LVIS HUD)

Purpose of the Study: The LVIS HUD is a small metallic mesh tube (or “stent”) that will be placed across the neck of the aneurysm and intended to remodel the blood vessel as well as provide support for the coils which will be placed inside the aneurysm.  These coils are small filaments of metal that facilitate aneurysm occlusion by blocking blood flow into the aneurysm.


Eligibility Criteria: The LVIS Device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck ≥ 4mm or dome to neck ratio <2), intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥2.5 mm and ≤ 4.5mm.


Study Status: Open


Principal Investigator: Patrick Youssef, MD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

NANO

Purpose of the Study: Currently there is no treatment for removal of iron from the brain after intracerebral hemorrhage (ICH). Iron is highly toxic and can lead to a host of issues including swelling and inflammation. This study is being done to determine if Deferoxamine is safe and effective at removal of the iron and leads to better outcomes in ICH patients.


Description: This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome. The procedural failure rate (defined above) of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences. This evaluation will occur within the framework of "non-inferiority" (i.e., comparable success to coiling of large aneurysms).


Eligibility Criteria: Men and women aged 18 to 90 years with a ruptured or un-ruptured cerebral aneurysm less than 4mm in diameter and otherwise appropriate for endovascular treatment as determined by the neurovascular team.


Study Status: Open to enrollment


Principal Investigator: Patrick Youssef, MD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu


Funding: University of Virginia

Treatment of intracranial aneurysms using Neuroform Microdelivery Stent System and embolic coils

Purpose of the Study:

  1. To determine the success rate of intracranial stent placement.
  2. To determine the success rate of aneurysm occlusion with the combined used of stent and GDC coils.
  3. To determine the rate of stenosis following intracranial stent placement at 6 months.
  4. To determine the 30 day clinical outcome of stent placement for GDC occlusion of intracranial aneurysms.  

 

Description: Research studies have not been done to test whether or not Neuroform Microdelivery and Neuroform EZ stent systems are effective for treating wide-necked brain aneurysms. The FDA is allowing the manufacturer of the Neuroform stent systems, Boston Scientific, to market the stent and allow doctors to use the stent under a Humanitarian Device Exemption. Before the FDA gave the exemption, they looked at information provided by the manufacturer and decided that the likely risks of using the Neuroform Microdelivery or Neuroform EZ stent systems are reasonable, compared to the possible benefits of using these stents and compared to other treatments for this condition. The effectiveness of Neuroform Microdelivery and Neuroform EZ stent systems for this condition has not been tested. This study is being done to determine how well Neuroform Microdelivery and Neuroform EZ stent systems can block a brain aneurysm.


Eligibility Criteria: We will not include subjects who are pregnant, incapable of giving informed written consent, or those who are mentally disabled in this study.

  1. Number of Study Subjects: In order to appropriately meet the specific aims given in this protocol we estimate that 56 patients will be necessary for this study.
  2. Age Range. > 18 years.
  3. Sex. Both male and female subjects will be studied. Due to the use of radiation and radiographic contrast, pregnant female subjects will be excluded from this protocol.


Inclusion Criteria: The Neuroform Microdelivery Stent System is for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of > 2mm and < 4.5 mm. Wide neck aneurysms are defined as having a neck > 4 mm or a done to neck ration of > 2. The vascular distributions would include: internal carotid artery (petrous segment and distal, and vertebrobasilar distribution (v4 segment and distal). In addition, an attending neurosurgeon familiar with aneurysm surgery must concur that endovascular treatment using the neuroform microdelivery system is more appropriate than surgical treatment.


Exclusion Criteria: The following subjects will be excluded from this study, including, but not limited to:

  1. Subjects in whom antiplatelet and/or anticoagulation therapy is contraindicated.
  2. Subjects who are pregnant or suspect they may be or have become pregnant. If reasonable doubt, testing with serum pregnancy test is required.
  3. Subjects who cannot adhere to the experimental protocols for any reason.
  4. Subjects who are less than 18 years of age.
  5. Subjects who cannot tolerate general anesthesia.
  6. Prisoners.
  7. Subjects in whom aneurysm treatment is not considered to be of benefit. (i.e. patient with short life expectancy and an unruptured aneurysm).


Study Status: Open


Principal Investigator: Ciaran J. Powers, MD, PhD


Contact: Alex Tranovich, Clinical Research Coordinator, alexander.tranovich@osumc.edu

Stroke Rehabilitation

Stroke Rehabilitation

Immersive 3D Gaming Therapy for Treating Hemispatial Neglect

Purpose of the Study: The purpose of this study is to examine a home-based, video game therapy for hemispatial neglect (ignoring things on the stroke-impaired side of the body).


Description: Participants will play a video game in their home between consultation sessions with a therapist. The game is easy to use and is played by looking with the eyes.


Eligibility Criteria: 18 years or older and have experienced a stroke or other type of brain damage that resulted in a diagnosis of hemispatial neglect


Study Status: recruiting


Principal Investigator: Dr. Lynne Gauthier


Contact: Dr. Lynne Gauthier
Phone: 614-293-6287
Email: lynne.gauthier@osumc.edu

Funding/Study Sponsor: Jeffrey Thomas Stroke Shield Foundation

Examining Mechanisms of Neuroplasticity Following Motor Rehabilitation In Stroke

Purpose of the Study: To determine the brain mechanisms underlying improvement from constraint-induced movement therapy (CI therapy)


Description: CI therapy is a highly efficacious treatment for residual motor disability in chronic stroke. Its effectiveness is believed to be due, at least in part, to the therapy’s ability to aid the brain in “rewiring itself.” For example, CI therapy produces increases in brain volume in certain areas of the human brain (Gauthier et al., 2008). The cellular and molecular mechanisms that are responsible for this increase in brain volume are not known, however. Thus, it is unclear how the therapy helps brains “rewire” themselves. Our laboratory is using new magnetic resonance imaging (MRI) techniques to better understand the time-course and cellular/molecular nature of brain changes during CI therapy. We are hopeful that by better understanding how CI therapy can change the brain, the effectiveness of rehabilitation can be improved.


Eligibility Criteria: Adult (18+) stroke patients experiencing arm weakness with some finger movement, who have not yet received CI therapy and are willing to forgo Botox therapy for upper extremity for 3 months prior to study enrollment


Study Status: recruiting


Principal Investigator: Dr. Lynne Gauthier


Contact:
Dr. Lynne Gauthier
Phone: 614-293-6287
Email: lynne.gauthier@osumc.edu


Funding/Study Sponsor: American Heart Association

Pivotal Phase III Trial to Determine the Therapeutic Effects of Navigation-Guided 1 Hz rTMS as Adjuvant to Task-Oriented Rehabilitation

Official Title: Pivotal Phase III, Prospective, Multicenter, Double-Blinded, Randomized, Sham-Controlled Trial to Determine the Therapeutic Effects of Navigation-Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task-Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke


Purpose of Study: To compare the outcomes following Nexstim NBS0-guided rTMS versus sham-rTMS in post-stroke patients


Description: This is a prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task-oriented rehabilitation and it will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks, and primary outcome will be assessed 6 months later. Participants will be evaluated on the upper extremity Fugl-Meyer score.


Eligibility Criteria: Adults (18+) who have experienced an ischemic or hemorrhagic stroke 3-12 months prior to the study, resulting in upper extremity paresis without any other known brain abnormalities


Exclusion Criteria: Implanted metallic parts, pregnancy, active alcohol abuse, illicit drug use or drug abuse or significant mental illness, depression, history of epilepsy, claustrophobia precluding MRI, a fixed contraction deformity in the affected limb that would prevent normal dexterity if patients were neurologically intact, excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb, previous stroke with residual deficits (TIAs not a reason for exclusion), premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology, a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3) or other major medical condition, confirmed or suspected lower-limb fracture preventing mobilization, patients requiring palliative care, patients planning to undergo any occupational therapy during the 6-week active treatment period of the trial (see section 5.2 for study schedule) other than what is provided in the study, a recent injection of Botox (past 3 months) or phenol (past 6 months) to the affected upper limb; severe ataxia, aphaia, or sensory deficits.


Study Status: Open to enrollment


Principal Investigator: Marcia Bockbrader, MD PhD (OSU site)/ Richard Harvey MD (multi-center PI)


Co-Investigators: Lise Worthen-Chaudhari, Stephen Page


Contact:
Marcia Bockbrader
Email: marcia.bockbrader@osumc.edu


Funding/Study Sponsor: Nexstim Ltd


Source: www.clinicaltrials.org # NCT02089464

Intensive Rehabilitation Targeting Upper Extremity Weakness: a Randomized, Controlled Trial

Purpose of the Study: The purpose of this study is to compare the effectiveness of 4 different interventions for treating upper-extremity weakness: 1) in-clinic Constraint-Induced Movement therapy; 2) Intensive motor training delivered in-home through a video game with 5 hours of therapist contact in the clinic; 3) Intensive motor training delivered in-home through a video game with 5 hours of therapist contact in the clinic and additional therapist tele-consultation; 4) standard in-clinic therapy.


Description: Constraint-Induced Movement therapy, or CI therapy, is an intensive motor intervention that teaches the brain to "rewire" itself following injury. CI therapy is the only rehabilitation technique known to markedly change the organization of activity in the brain and remodel brain structures. The video game intervention translates the most critical components of CI therapy into an engaging intervention that can be done at home. Game play is easy to master and is controlled by moving the hand and arm.


Eligibility Criteria: Adult (18+) stroke patients experiencing arm weakness with some finger movement, who have not yet received CI therapy and are willing to forgo Botox therapy for upper extremity for 3 months prior to study enrollment.


Study Status: Recruiting


Principal Investigator: Dr. Lynne Gauthier


Contact:
Dr. Lynne Gauthier
Phone: 614-293-6287
Email: lynne.gauthier@osumc.edu


Funding/Study Sponsor: PCORI

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