Combined tDCS+PNS After Acute Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01207336
First received: September 21, 2010
Last updated: April 5, 2012
Last verified: April 2012

September 21, 2010
April 5, 2012
September 2010
September 2012   (final data collection date for primary outcome measure)
Jebsen Taylor test [ Time Frame: 5-15-30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01207336 on ClinicalTrials.gov Archive Site
Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS) [ Time Frame: 5-15-30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Combined tDCS+PNS After Acute Stroke
Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischaemic Stroke
Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulation
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
September 2012   (final data collection date for primary outcome measure)

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

Both
35 Years to 85 Years
No
Contact: Marion SIMONETTA-MOREAU, MD PhD simonetta.m@chu-toulouse.fr
France
 
NCT01207336
C09-27, 2009-A01153-54
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Fondation de l'Avenir
Study Director: Marion SIMONETTA-MOREAU, MDPhD Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, France
Principal Investigator: François CHOLLET, MDPhD Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France

Institut National de la Santé Et de la Recherche Médicale, France
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP