Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial "NICHE"

Completed

Phase N/A Results N/A

Trial Description

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

  • Sham rTMS Device
    ARM 1: Kind: Experimental
    Label: Sham rTMS
    Description: Sham rTMS + task-oriented rehabilitation
    ARM 2: Kind: Experimental
    Label: Sham rTMS + task-oriented rehabilitation
    Description: Sham rTMS + task-oriented rehabilitation
  • NBS-guided rTMS Device
    Other Names: Nexstim
    ARM 1: Kind: Experimental
    Label: NBS-rTMS
    Description: NBS-guided rTMS + task-oriented rehabilitation
    ARM 2: Kind: Experimental
    Label: NBS-rTMS + task-oriented rehabilitation
    Description: NBS-guided rTMS + task-oriented rehabilitation
  • Task oriented rehabilitation Procedure
    ARM 1: Kind: Experimental
    Label: NBS-rTMS + task-oriented rehabilitation
    Description: NBS-guided rTMS + task-oriented rehabilitation
    ARM 2: Kind: Experimental
    Label: Sham rTMS + task-oriented rehabilitation
    Description: Sham rTMS + task-oriented rehabilitation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper extremity Fugl-Meyer score Baseline - 6 months post-treatment No
Secondary Arm-Research Action Test (ARAT) Baseline - 6 months post-treatment No
Secondary Wolf Motor Function Test Baseline - 6 months post-treatment No
Secondary NIH Stroke Scale (NIHSS) Baseline - 6 months post-treatment No
Secondary Chedoke-McMaster Stroke Assessment (CMSA) Baseline - 6 months post-treatment No
Secondary Stroke Impact Scale (SIS) Baseline - 6 months post-treatment No
Secondary Patient Health Questionnaire (PHQ9) Baseline - 6 months post-treatment No
Secondary Quality of life assessment: EQ-5D Baseline - 6 months post-treatment No

Sponsors