Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial "E-FIT"

Recruiting

Phase N/A Results N/A

Trial Description

A prospective, multi-center, randomized, sham-controlled, 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 of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Conditions

Interventions

  • Nexstim NBS guided active rTMS Device
    Intervention Desc: Nexstim NBS guided active rTMS + standardized task-oriented therapy
    ARM 1: Kind: Experimental
    Label: Active
    Description: Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation
  • Nexstim NBS guided sham rTMS Device
    Intervention Desc: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
    ARM 1: Kind: Experimental
    Label: Control
    Description: Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper extremity Fugl-Meyer score Baseline to 6 months after end of treatment
Secondary Arm-Research Action Test (ARAT) Baseline to 6 months after end of treatment
Secondary NIH Stroke Scale (NIHSS) Baseline to 6 months after end of treatment
Secondary Quality of life assessment: EQ-5D Baseline to 6 months after end of treatment

Sponsors