Transcranial Stimulation in Motor Stroke Rehabilitation

Completed

Phase N/A Results N/A

Trial Description

Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.
Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

Conditions

Interventions

  • TDCS Device
    Intervention Desc: Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
    ARM 1: Kind: Experimental
    Label: tDCS+rTMS
    Description: Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.
    ARM 2: Kind: Experimental
    Label: rTMS+tDCS
    Description: Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.
  • RTMS Device
    Intervention Desc: Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
    ARM 1: Kind: Experimental
    Label: tDCS+rTMS
    Description: Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.
    ARM 2: Kind: Experimental
    Label: rTMS+tDCS
    Description: Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.
  • Sham Device
    Intervention Desc: Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
    ARM 1: Kind: Experimental
    Label: Sham stimulation
    Description: Stroke patients were treated with two weeks of sham transcranial direct current stimulation.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement) Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months No
Secondary P300 (latency) Baseline; 1 month; 6 months and 1 week; 7 months No
Secondary Cognition (standardized neuropsychological assessment) Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months No

Sponsors