We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT02089464
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Stroke Device: NBS-guided rTMS Device: Sham rTMS Procedure: Task oriented rehabilitation

Study Design

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
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Upper extremity Fugl-Meyer score [ Time Frame: Baseline - 6 months post-treatment ]

Secondary Outcome Measures :
  1. Arm-Research Action Test (ARAT) [ Time Frame: Baseline - 6 months post-treatment ]
  2. Wolf Motor Function Test [ Time Frame: Baseline - 6 months post-treatment ]
  3. NIH Stroke Scale (NIHSS) [ Time Frame: Baseline - 6 months post-treatment ]
  4. Chedoke-McMaster Stroke Assessment (CMSA) [ Time Frame: Baseline - 6 months post-treatment ]
  5. Stroke Impact Scale (SIS) [ Time Frame: Baseline - 6 months post-treatment ]
  6. Patient Health Questionnaire (PHQ9) [ Time Frame: Baseline - 6 months post-treatment ]
  7. Quality of life assessment: EQ-5D [ Time Frame: Baseline - 6 months post-treatment ]

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 ]

Eligibility Criteria

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02089464


Locations
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
Investigators
Principal Investigator: Richard L Harvey, MD Shirley Ryan AbilityLab
More Information

Responsible Party: Nexstim Ltd
ClinicalTrials.gov Identifier: NCT02089464     History of Changes
Other Study ID Numbers: NX92325
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases