Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
United States199 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infe…