Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

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.