tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

Recruiting

Phase N/A Results N/A

Trial Description

The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.

Conditions

Interventions

  • Constraint induced movement therapy (CIMT) Behavioral
    Other Names: hand therapy; CIMT; forced use therapy; constraint induced movement therapy; stroke therapy; stroke rehabilitation
    Intervention Desc: 2 weeks of CIMT
    ARM 1: Kind: Experimental
    Label: CIMT + active anodal tDCS
    Description: Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
    ARM 2: Kind: Experimental
    Label: CIMT + sham tDCS
    Description: Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation
  • Active anodal transcranial Direct Current Stimulation (tDCS) Device
    Other Names: tDCS; Non invasive brain stimulation; transcranial stimulation
    Intervention Desc: Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
    ARM 1: Kind: Experimental
    Label: CIMT + active anodal tDCS
    Description: Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
  • Sham transcranial Direct Current Stimulation Device
    Other Names: Sham
    Intervention Desc: sham transcranial Direct Current Stimulation 30 min with CIMT
    ARM 1: Kind: Experimental
    Label: CIMT + sham tDCS
    Description: Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Upper Limb function Baseline and posttest (an average of 2 weeks from baseline) No
Secondary GABA (gamma-aminobutyric acid) activity Baseline No
Secondary Motor function after single session of tDCS Baseline No

Sponsors