Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02089464
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Information provided by (Responsible Party):
Nexstim Ltd

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.

Condition or disease Intervention/treatment Phase
Stroke Device: NBS-guided rTMS Device: Sham rTMS Procedure: Task oriented rehabilitation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pivotal Phase III, Prospective, Multicenter, Double Blinded, Randomized, Sham Controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke
Study Start Date : April 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: NBS-rTMS + task-oriented rehabilitation
NBS-guided rTMS + task-oriented rehabilitation
Device: NBS-guided rTMS
Other Name: Nexstim

Procedure: Task oriented rehabilitation
Sham Comparator: Sham rTMS + task-oriented rehabilitation
Sham rTMS + task-oriented rehabilitation
Device: Sham rTMS
Procedure: Task oriented rehabilitation

Primary Outcome Measures :
  1. Upper Extremity Fugl-Meyer Score [ Time Frame: Baseline - 6 months post-treatment ]
    Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).

Secondary Outcome Measures :
  1. Arm-Research Action Test (ARAT) [ Time Frame: Baseline - 6 months post-treatment ]
    Scale minimum 0, maximum 57. Greater values indicate better motor function.

  2. Wolf Motor Function Test [ Time Frame: Baseline - 6 months post-treatment ]
    Time in seconds to perform test tasks. Shorter time indicates better motor function.

  3. NIH Stroke Scale (NIHSS) [ Time Frame: Baseline - 6 months post-treatment ]
    Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)

  4. Chedoke-McMaster Stroke Assessment (CMSA) [ Time Frame: Baseline - 6 months post-treatment ]
    Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.

  5. Stroke Impact Scale (SIS) [ Time Frame: Baseline - 6 months post-treatment ]
    Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function

  6. Patient Health Questionnaire (PHQ9) [ Time Frame: Baseline - 6 months post-treatment ]
    The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood

  7. Quality of Life Assessment: EuroQol EQ-5D Scale [ Time Frame: Baseline - 6 months post-treatment ]
    The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.

Other Outcome Measures:
  1. To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups [ Time Frame: Baseline - 6 months post-treatment ]
    Serious Adverse Events were recorded and their occurrence was compared between treatment arms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02089464

Layout table for location information
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
United States, Georgia
Shepherd Rehabilitation Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
United States, New York
Columbia Cornell New York Presbyterian Hospital
New York, New York, United States, 10032
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, United States, 10605
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
TIRR Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nexstim Ltd
Layout table for investigator information
Principal Investigator: Richard L Harvey, MD Shirley Ryan AbilityLab
Publications of Results:
Layout table for additonal information
Responsible Party: Nexstim Ltd Identifier: NCT02089464    
Other Study ID Numbers: NX92325
First Posted: March 17, 2014    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases