Combined tDCS+PNS After Acute Stroke

Phase 3CompletedNCT01207336

Institut National de la Santé Et de la Recherche Médicale, France20 enrolled

Overview

Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke. The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS. Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Ischaemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS \<15 age 35-85 years Exclusion Criteria: Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS

Outcomes

Primary Outcomes

Jebsen Taylor test

Time frame: 5-15-30 days

Secondary Outcomes

Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS)