niche trial: navigated inhibitory rtms to contralesional hemisphere trial

Conditions: Stroke

Summary: a pivotal, 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 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.


Eligibility criteria:
inclusion criteria : * ≥ 18 years of age * an ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; * no other known brain abnormalities by history; * a one-sided stroke resulting in upper extremity paresis * a chedoke-mcmaster stroke assessment arm stage and hand stage of 3-6 for the affected limb exclusion criteria * implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; * pregnant or trying to become pregnant; lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. * active alcohol abuse, illicit drug use or drug abuse or significant mental illness * patients suffering from depression as measured by a score of \>10 on the patient health questionnaire (phq9). for clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom phq9 is \<10 are eligible to participate in the trial. * history of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, or a seizure within the last 12 months. * any condition that would prevent the subject from giving voluntary informed consent; * an implanted brain stimulator; * any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; * enrolled or plans to enroll in an interventional trial during this study; * scalp wounds or infections; * 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;i * 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 botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. * a recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. * ataxia as measured by a score \> 1 on item 7 (limb ataxia) of the nih stroke scale. * severe sensory deficits as measured by a score of 2 on item 8 of the nih stroke scale. * severe aphasia as measured by a score of \> 2 on item 9 (best language) of the nih stroke scale. * severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the nih stroke scale. * patients unable to comprehend or follow verbal commands * based on pi's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition * a mini mental status exam (mmse) \<25.