Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke

Completed

Phase 1/2 Results N/A

Trial Description

The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Detailed Description

Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Other Names: tDCS
    ARM 1: Kind: Experimental
    Label: Active tdcs/M1
    Description: Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
    ARM 2: Kind: Experimental
    Label: Active tdcs/Premotor
    Description: Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
    ARM 3: Kind: Experimental
    Label: Sham tdcs
    Description: Sham tDCS and CIMT (constraint induced movement therapy)
  • Constraint-Induced Movement Therapy Procedure
    ARM 1: Kind: Experimental
    Label: Active tdcs/M1
    Description: Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
    ARM 2: Kind: Experimental
    Label: Active tdcs/Premotor
    Description: Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
    ARM 3: Kind: Experimental
    Label: Sham tdcs
    Description: Sham tDCS and CIMT (constraint induced movement therapy)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Independence measured by Barthel Index Change for functional independence at 15 days No
Secondary Spasticity (Modified Ashworth Scale) Baseline and Week 2 No
Secondary Muscle strength (Medical Research Council Scale) Baseline and Week 2 No

Sponsors