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
  Purpose

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


Condition Intervention Phase
Acute Ischaemic Stroke
Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Jebsen Taylor test [ Time Frame: 5-15-30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS) [ Time Frame: 5-15-30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207336

Contacts
Contact: Marion SIMONETTA-MOREAU, MD PhD simonetta.m@chu-toulouse.fr

Locations
France
Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan) Recruiting
Toulouse, France, 31059
Contact: Fabienne Calvas, MD    0033561772407    fabienne.calvas@inserm.fr   
Principal Investigator: Marion SIMONETTA-MOREAU, MDPhD         
Sub-Investigator: Claire THALAMAS, MD         
Sub-Investigator: Angélique GERDELAT-MAS, MD         
Sub-Investigator: Fabienne CALVAS, MD         
Sub-Investigator: François CHOLLET, MDPhD         
Sub-Investigator: Jean-François ALBUCHER, MD         
Sub-Investigator: Nicolas RAPOSO, MD         
Sub-Investigator: Isabelle Loubinoux, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Fondation de l'Avenir
Investigators
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

  More Information

Additional Information:
INSERM  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01207336     History of Changes
Other Study ID Numbers: C09-27, 2009-A01153-54
Study First Received: September 21, 2010
Last Updated: April 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
stroke
rehabilitation
transcranial direct current stimulation
nerve stimulation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014