Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.

Conditions

Interventions

  • TDCS Device
    Intervention Desc: Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
    ARM 1: Kind: Experimental
    Label: Sham
    Description: Motor training of the affected upper extremity combined with sham tDCS.
    ARM 2: Kind: Experimental
    Label: tDCS
    Description: Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).

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 Change from baseline in Upper Extremity Fugl Meyer Assessment Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks No
Secondary ARAT Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks No
Secondary Hand grip strength Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks No
Secondary 10-meter walk test Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks No
Secondary EuroQol-5D 12 weeks No
Secondary Barthel Index Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks No
Secondary HADS Baseline; 4 weeks and 12 weeks No
Secondary MoCA Baseline; 4 weeks and 12 weeks No
Secondary Wong-Baker FACES Pain Rating Scale Every stimulation session No

Sponsors