Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
NCT02089464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2020-09-01
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
Interventions
- DEVICE
-
NBS-guided rTMS
- DEVICE
-
Sham rTMS
- PROCEDURE
-
Task oriented rehabilitation
Sponsors & Collaborators
-
Nexstim Ltd
lead INDUSTRY
Principal Investigators
-
Richard L Harvey, MD · Shirley Ryan AbilityLab
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-05-31
- Completion
- 2016-05-31
Countries
- United States
Study Locations
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