Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke "NEUROSTIM"

Recruiting

Phase N/A Results N/A

Trial Description

Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).

Detailed Description

The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.

Conditions

Interventions

  • Physical therapy Other
    Intervention Desc: Physical therapy will be administered for 60 minutes
    ARM 1: Kind: Experimental
    Label: Active tDCS+ Physical Therapy
    Description: Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
    ARM 2: Kind: Experimental
    Label: Sham tDCS+Physical Therapy
    Description: Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
  • Sham tDCS Device
    Intervention Desc: In sham tDCS, no current will be delivered through the tDCS device.
    ARM 1: Kind: Experimental
    Label: Sham tDCS+Physical Therapy
    Description: Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
  • Active tDCS Device
    Intervention Desc: Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
    ARM 1: Kind: Experimental
    Label: Active tDCS+ Physical Therapy
    Description: Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety of the intervention as assessed by frequency of adverse events 2 weeks Yes
Secondary Improvement post treatment as measured by the Modified Rankin Scale 2 weeks and 14 weeks No
Secondary Improvement post treatment as measured by the NIH Stroke Scale 2 weeks and 14 weeks No
Secondary Improvement post treatment as measured by the Stroke Impact Scale 2 weeks and 14 weeks No
Secondary Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke 2 weeks and 14 weeks No
Secondary Improvement post treatment as measured by the Modified Ashworth Scale 2 weeks and 14 weeks No
Secondary Improvement post treatment as measured by the Motor Activity Log 2 weeks and 14 weeks No
Secondary Montreal Cognitive Assessment Test 2 weeks and 14 weeks No
Secondary Structural Connectivity as measured by diffusion tensor imaging analysis 2 weeks No
Secondary Functional Connectivity as measured by resting-state functional magnetic imaging analysis 2 weeks No
Secondary Improvement post treatment as measured by the Barthel index 2 week and 14 weeks No
Secondary Improvement post treatment as measured by Pittsburgh Sleep Quality Index 2 week and 14 weeks

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