Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial (NICHE)

Nexstim

Status: Completed

Conditions: Stroke

Treatments: Device: Sham rTMS; Procedure: Task oriented rehabilitation; Device: NBS-guided rTMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089464

NX92325

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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199 participants in 2 patient groups

NBS-rTMS + task-oriented rehabilitation

Active Comparator group

Description:

NBS-guided rTMS + task-oriented rehabilitation

Treatment:

Device: NBS-guided rTMS

Procedure: Task oriented rehabilitation

Sham rTMS + task-oriented rehabilitation

Sham Comparator group

Description:

Sham rTMS + task-oriented rehabilitation

Treatment:

Device: Sham rTMS

Procedure: Task oriented rehabilitation