Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
NICHE
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
1 other identifier
interventional
199
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Apr 2014
Typical duration for not_applicable stroke
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
September 1, 2020
CompletedSeptember 1, 2020
August 1, 2020
2.1 years
March 14, 2014
August 4, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Upper Extremity Fugl-Meyer Score
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).
Baseline - 6 months post-treatment
Secondary Outcomes (7)
Arm-Research Action Test (ARAT)
Baseline - 6 months post-treatment
Wolf Motor Function Test
Baseline - 6 months post-treatment
NIH Stroke Scale (NIHSS)
Baseline - 6 months post-treatment
Chedoke-McMaster Stroke Assessment (CMSA)
Baseline - 6 months post-treatment
Stroke Impact Scale (SIS)
Baseline - 6 months post-treatment
- +2 more secondary outcomes
Other Outcomes (1)
To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups
Baseline - 6 months post-treatment
Study Arms (2)
NBS-rTMS + task-oriented rehabilitation
ACTIVE COMPARATORNBS-guided rTMS + task-oriented rehabilitation
Sham rTMS + task-oriented rehabilitation
SHAM COMPARATORSham rTMS + task-oriented rehabilitation
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
- 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,
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nexstim Ltdlead
Study Sites (12)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Shepherd Rehabilitation Center
Atlanta, Georgia, 30309, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Indiana University Indianapolis
Indianapolis, Indiana, 46202, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129, United States
Columbia Cornell New York Presbyterian Hospital
New York, New York, 10032, United States
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, 10605, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio State University
Columbus, Ohio, 43210, United States
TIRR Memorial Hermann Hospital
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 30354990RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs
- Organization
- Nexstim Plc
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Harvey, MD
Shirley Ryan AbilityLab
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2014
First Posted
March 17, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
September 1, 2020
Results First Posted
September 1, 2020
Record last verified: 2020-08