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
Funding/Study Sponsor: Nexstim Ltd
Source: www.clinicaltrials.org # NCT02089464