Traumatic Brain Injury (TBI)

Traumatic Brain Injury (TBI)

Embedded Arts: randomized control trial (RCT) to evaluate effect of creative engagement on motor outcomes in neurorehabilitation

Purpose of Study: This study will examine the importance of patient creative engagement for neurorecovery gains.


Description: This is a randomized control trial evaluating the effect of patient creative engagement on neurorecovery gains following brain injury. This work leverages the advantages of creative arts and immersive video to provide new “Engaged Medicine” technology. Ultimately, the digital platform of this work advances a big data approach to health care that has tremendous potential to connect patients across the continuum of their care experience, from hospital based care to home care through telemedicine to self-care.


Principal Investigator: Lise Worthen-Chaudhari


Contact:
Lise Worthen-Chaudhari
Phone: 614 293-6281
Email: Lise.Worthen-Chaudhari@osumc.edu


Funding/Study Sponsor: Center for Personalized Health Care, OSUWMC

Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)

Purpose of Study: The purpose of this study is to examine the efficacy of multiplayer gaming paradigms such as Dr. Jane McGonigal's SuperBetter and similar positive play games as intervention tools to help patients with mild to moderate brain injury transition from therapeutic care to self-management at home.


Description: This is a phase I clinical testing (feasibility) study to determine whether a rehabilitation game is appropriate for use with mild traumatic brain-injured children and teens. SuperBetter (SuperBetter, LLC, Sausilito, CA) is a positive-play game developed to employ both social networking and alternate reality theory to achieve rehabilitative goals. SuperBetter assigns points to gamers for attaining health goals such as remembering to take medications each day, avoiding circumstances that exacerbate symptoms, checking in with someone within their trusted network (i.e., reaching out to loved ones for support). Positive-play games like McGonigal's SuperBetter are promising novel interventions that could make a positive difference in the ability of patients to successfully transition to self-care after discharge from therapeutic care. Investigators will evaluate the feasibility of SuperBetter through recorded pilot data, which will be used to plan a clinical effectiveness follow-up study. The goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.


Eligibility Criteria: Patients ages 15-25 years diagnosed with mild or moderate traumatic brain injury


Study Status: Recruitment closed, analysis pending


Principal Investigator: Lise Worthen-Chaudhari and Dr. Jane McGonigal


Co-Investigators: Mysiw, Keith O Yeates, Kelsey Logan


Contact:
Lise Worthen-Chaudhari
Phone: 614 293-6281
Email: Lise.Worthen-Chaudhari@osumc.edu


Funding/Study Sponsor: The Ohio State University


Source: www.clinicaltrials.org #NCT01398566

Ohio Regional Traumatic Brain Injury Model Systems Study (ORTBIMS)

Purpose of the Study: The ORTBIMS is one of the sites for the National TBI Model Systems study, which is a longitudinal study of long-term outcomes following traumatic brain injury (TBI).


Description: The Traumatic Brain Injury Model System (TBIMS) program is funded by the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) to demonstrate the benefits of a coordinated system of neurotrauma and rehabilitation care and to conduct innovative research on all aspects of care for those who sustain traumatic brain injuries. The mission of the TBIMS is to improve the lives of persons who experience TBI, their families and their communities by creating and disseminating new knowledge about the course, treatment and outcomes relating to their condition.


Ohio Regional TBIMS (ORTBIMS) is one of 16 centers throughout the United States that provide comprehensive systems of brain injury care to individuals who sustain a traumatic brain injury, from acute care through community re-entry. The ORTBIMS has been continuously funded since 1997, has enrolled over 1,000 participants and is following participants up to 15 years post-injury.


At the heart of the program is a long-term, longitudinal study of patients who receive rehabilitation for TBI. Each center systematically collects important data about eligible individuals with TBI. Consenting patients are followed 1, 2, 5, 10 and every 5 years thereafter to learn about the long-term effects of moderate and severe TBI. Each center contributes data to the Traumatic Brain Injury Model Systems National Data and Statistical Center (TBINDSC) located at Craig Hospital in Englewood, CO.


Eligibility Criteria: The population consists of individuals who sustain moderate or severe traumatic brain injuries meeting the following case definition: The person sustained a traumatic brain injury, which is defined as damage to brain tissue caused by an external force as evidenced by loss of consciousness, post-traumatic amnesia, or objective neurological findings that can be attributed to a traumatic brain injury. Penetrating wounds fitting this definition are included. Lacerations or bruises of the scalp or forehead without the other listed criteria are excluded. Primary anoxic encephalopathy is excluded.


Inclusion criteria:

  1. The person fits the above definition
  2. The person meets at least one of the following criteria for moderate to severe TBI:
  1. post-traumatic amnesia > 24 hours
  2. trauma-related intracranial neuroimaging abnormalities
  3. loss of consciousness > 30 minutes (unless due to sedation or intoxication)
  4. Glasgow Coma Scale in the emergency department less than 13 (unless due to intubation, sedation or intoxication)
  1. The person is 16 years of age or older
  2. The person presented to a Model System acute care hospital emergency department within 72 hours post-injury
  3. The person has received both acute care and rehabilitation through a designated Model System hospital. Comprehensive rehabilitation must occur in a hospital, rehabilitation unit, rehabilitation hospital, hospital-based skilled nursing facility or long-term care acute care hospital that meets the following criteria:
  1. medical and rehabilitation care are supervised on a regular basis by a physician affiliated with a model system
  2. 24-hour nursing care is provided to the patient
  3. comprehensive rehabilitation is available to the patient as needed with the expectation of further functional gain
  4. data required by the National TBI Model System database are accessible and transferable to the National Data Center with appropriate informed consent
  1. The person with the brain injury or a family member/legal representative understands and signs an informed consent form

Study Status: Recruitment is ongoing


Principal Investigator: John D. Corrigan, PhD and Jennifer Bogner, PhD


Contact:
Monica Lichi, MS Ed, PC, MBA
Phone: 614-293-3802
Email: Monica.Lichi@osumc.edu


Funding/Study Sponsor: National Institute on Disability, Independent Living and Rehabilitation Research, Administration for Community Living

Rehabilitation Interventions

Purpose of the Study: 1) Determine the comparative effectiveness of different therapeutic approaches (contextualized vs. decontextualized; advanced vs. standard of care) used in inpatient traumatic brain injury (TBI) rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches, and 2) Determine the comparative effectiveness of difference in the delivery (family involvement in treatment, time vs. level of effort in therapy) of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit.


Description: TBI is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period than used in previous studies.


The current study employs propensity score analysis to compare the effectiveness of rehabilitation interventions for TBI on participation, functional independence and subjective well-being. Data will be drawn from the database established for the TBI Practice-Based Evidence Study (TBI-PBE Study). Data on 2,130 persons who received inpatient TBI rehabilitation at any of 10 sites (9 in the United States, 1 in Canada) were obtained for the study. Detailed longitudinal data were collected prospectively on rehabilitation therapies (with point-of-care data completed for every clinical encounter), course of recovery, person and injury characteristics and outcomes during and after rehabilitation. Advanced analytic methods will be used to compare the effects of different rehabilitation interventions on outcomes at discharge and during the 9 months following rehabilitation.


Eligibility Criteria: The study sample was drawn from the population of persons who received inpatient rehabilitation for TBI in North America. Ten enrollment sites (9 in the United States and 1 in Canada) enrolled a consecutive sample of 2,130 patients who met the following inclusion criteria:

  1. Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture or objective neurological findings
  2. Diagnosed with an International Classification of Diseases (ICD-9-CM) code consistent with the CDC Guidelines for Surveillance of Central Nervous System Injury
  3. Receiving inpatient care on a designated brain injury rehabilitation unit of one of the participating rehabilitation facilities
  4. Incurred a TBI severe enough to warrant inpatient rehabilitation regardless of other injuries, with TBI being the predominant reason for rehabilitation admission

Study Status: Recruitment is closed; analyses are being conducted


Principal Investigator: Jennifer Bogner, PhD


Contact: Jennifer Bogner, PhD
Phone: 614-293-3830
Email: Jennifer.Bogner@osumc.edu


Funding/Study Sponsor: PCORI

Brief Intervention for Substance Misuse Following Moderate or Severe TBI: A Randomized, Controlled Trial

Purpose of the Study: The purpose of this study is to test ways of improving health after traumatic brain injury (TBI) by increasing healthy habits. We are specifically looking at ways to increase brain health, including reducing alcohol use after brain injury.


Description: This single-masked, parallel-group, randomized, controlled trial represents the next step in a series of studies to develop a method for decreasing substance misuse and increasing healthy habits, thereby improving outcomes, after TBI. The study will determine if the addition of a booster session and planned accommodations during the brief intervention improves efficacy of the Screening and Brief Intervention (SBI). In addition, secondary outcomes of interest are included to allow evaluation of mechanisms of change, with the aim of further refining the SBI in future studies, as well as identifying the best responders to the intervention.


Eligibility Criteria: Participants must be 18 and older and must have sustained a TBI requiring inpatient rehabilitation at Dodd Hall, have a history of alcohol misuse, are English-speaking, cleared post-traumatic amnesia, are free of language impairments precluding participation in the intervention, and able and willing to provide informed consent.


Study Status: Recruitment is ongoing


Principal Investigator: Jennifer Bogner, PhD


Contact: Jennifer Bogner, PhD
Phone: 614-293-3830
Email: Jennifer.Bogner@osumc.edu


Funding/Study Sponsor: National Institute on Disability, Independent Living and Rehabilitation Research, Administration for Community Living

Spinal Cord Injury

Spinal Cord Injury

Training Frontal Plane Eccentric Motor Control to Improve Locomotion After iSCI

Purpose of Study: This project will evaluate effectiveness of an eccentrically focused treadmill training program for retraining frontal plane gait motion among individuals with spinal cord injury.


Principal Investigator: Michele Basso, EdD


Co-Investigators: Lise Worthen-Chaudhari, James Schmiedeler


Contact:
Michele Basso, EdD
Email: michele.basso@osumc.edu

Lise Worthen-Chaudhari, MFA, MS
Email: lise.worthen-chaudhari@osumc.edu


Funding/Study Sponsor: Neilsen Foundation (SCRIPTS Pilot Grant)

Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Knee Function During Walking

Purpose of Study: This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of moderate-speed downhill training for the rehabilitation eccentric function of the knee.


Description: This is a randomized interventional study to measure the efficacy of downhill walking training in individuals with spinal cord injury. Training will occur 3 times a week for 12 weeks with a 4-week follow-up period. This intervention will be delivered by trained therapists. To focus on rehabilitation of knee control, members of this group will be trained at moderate gait speeds.


Eligibility Criteria: Adults (18+) with spinal cord injury discharged from outpatient rehabilitation for 6 months. Exclusions: Lower motor neuron injury in legs, use of Botox in the past 3 months, pre-existing or confounding neurologic conditions (i.e., brain injury, stroke, HIV), acute deep vein thrombosis, pregnancy, ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment, persistent orthostatic hypotension (drop of BP >30mmHg in treadmill and harness equipment), history of myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study.


Study Status: Open to enrollment


Principal Investigator: Michele Basso, EdD


Co-Investigators: Lise Worthen-Chaudhari, James Schmiedeler


Contact: Michele Basso, EdD
Email: michele.basso@osumc.edu

Lise Worthen-Chaudhari, MFA, MS
Email: lise.worthen-chaudhari@osumc.edu


Funding/Study Sponsor: The Ohio State University


Source: www.clinicaltrials.org # NCT02498548

Stroke

Stroke

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, 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 Sroke

Purpose of the Study: to determine the brain mechanisms underlying improvement from Constraint-Induced (CI) movement 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, 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 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 patient 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 other occupational therapy during the 6-week active treatment period of the trial (see section 5.2 for study schedule) 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. The interventions are: 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 to 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

Other Conditions

Other Conditions

Multiple Sclerosis Hand/Arm Neurorehabilitation Study: In-home Virtual Reality Gaming

Purpose of the Study: The purpose of this study is to determine whether an intensive, in-home, video game-based intervention improves hand and arm function in individuals with progressive multiple sclerosis (MS). The video game is easy to operate and game play is driven entirely by movements of the weaker hand and arm.


Eligibility Criteria: Adults (18+) diagnosed with of primary progressive or secondary progressive MS, experiencing arm weakness and who have not already received CI movement therapy


Study Status: Recruiting


Principal Investigator: Dr. Lynne Gauthier


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


Funding/Study Sponsor: National Multiple Sclerosis Society, Rudi Schulte Foundation

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