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Clinical Trials/NCT01207336
NCT01207336
Completed
Phase 2

Effect of Combined Anodal TDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country20 target enrollmentSeptember 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Acute Ischaemic Stroke
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
20
Locations
1
Primary Endpoint
Jebsen Taylor test
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
August 30, 2012
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

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)(5-15-30 days)

Study Sites (1)

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