Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

NCT ID: NCT02089464

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-05-31

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NBS-rTMS + task-oriented rehabilitation

NBS-guided rTMS + task-oriented rehabilitation

Group Type: ACTIVE_COMPARATOR

NBS-guided rTMS

Intervention Type: DEVICE

Task oriented rehabilitation

Intervention Type: PROCEDURE

Sham rTMS + task-oriented rehabilitation

Sham rTMS + task-oriented rehabilitation

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

Task oriented rehabilitation

Intervention Type: PROCEDURE

Interventions

NBS-guided rTMS

Intervention Type: DEVICE

Sham rTMS

Intervention Type: DEVICE

Task oriented rehabilitation

Intervention Type: PROCEDURE

Other Intervention Names

Nexstim

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nexstim Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Harvey, MD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Mayo Clinic

Phoenix, Arizona, United States

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Shepherd Rehabilitation Center

Atlanta, Georgia, United States

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Indiana University Indianapolis

Indianapolis, Indiana, United States

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Columbia Cornell New York Presbyterian Hospital

New York, New York, United States

Burke Medical Research Institute, Weill Cornell Neurology

White Plains, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

TIRR Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

References

Harvey RL, Edwards D, Dunning K, Fregni F, Stein J, Laine J, Rogers LM, Vox F, Durand-Sanchez A, Bockbrader M, Goldstein LB, Francisco GE, Kinney CL, Liu CY; NICHE Trial Investigators *. Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke. Stroke. 2018 Sep;49(9):2138-2146. doi: 10.1161/STROKEAHA.117.020607.

Reference Type: RESULT

PMID: 30354990 (View on PubMed)

Other Identifiers

NX92325

Identifier Type: -

Identifier Source: org_study_id