Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial "NICHE"


Phase N/A Results N/A

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.