Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation "START-tDCS"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke

Detailed Description

Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.
In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.
However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.
With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    ARM 1: Kind: Experimental
    Label: Active tdcs / CIMT
    Description: Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Sham stimulation / CIMT
    Description: Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)
  • Constraint-Induced Movement Therapy Procedure
    ARM 1: Kind: Experimental
    Label: Active tdcs / CIMT
    Description: Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)
    ARM 2: Kind: Experimental
    Label: Sham stimulation / CIMT
    Description: Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)

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 4 months No
Secondary Cognitive dysfunction (Montreal Cognitive Assessment) Baseline (week 1) and Endpoint (week 4) Yes
Secondary Executive functions (Victoria version of the Stroop Color and Word Test) Baseline (week 1) and Endpoint (week 4) Yes
Secondary Attention and Working Memory (Digit span subtest) Baseline (week 1) and Endpoint (week 4) Yes
Secondary Spasticity Baseline, Week 2 and Week 4 No
Secondary Muscle strength Baseline, Week 2 and Week 4 No
Secondary Balance Baseline, Week 2 and Week 4 No
Secondary Posture Baseline, Week 2 and Week 4 No
Secondary Fear of falling during daily life activities Baseline, Week 2 and Week 4 No
Secondary Upper limb function Baseline, Week 2 and Week 4 No
Secondary Quality of life Baseline, Week 2 and Week 4 No
Secondary Lower limb function Baseline, Week 2 and Week 4 No

Sponsors