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Combined tDCS+PNS After Acute Stroke

Primary Purpose

Acute Ischaemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
combined transcranial direct current stimulation and electrical peripheral nerve stimulation
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischaemic Stroke focused on measuring stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan)Recruiting

Outcomes

Primary Outcome Measures

Jebsen Taylor test

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2010
Last Updated
April 5, 2012
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT01207336
Brief Title
Combined tDCS+PNS After Acute Stroke
Official Title
Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Fondation de l'Avenir

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischaemic Stroke
Keywords
stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
combined transcranial direct current stimulation and electrical peripheral nerve stimulation
Intervention Description
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
Primary Outcome Measure Information:
Title
Jebsen Taylor test
Time Frame
5-15-30 days
Secondary Outcome Measure Information:
Title
Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS)
Time Frame
5-15-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion SIMONETTA-MOREAU, MD PhD
Email
simonetta.m@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion SIMONETTA-MOREAU, MDPhD
Organizational Affiliation
Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
François CHOLLET, MDPhD
Organizational Affiliation
Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne Calvas, MD
Phone
0033561772407
Email
fabienne.calvas@inserm.fr
First Name & Middle Initial & Last Name & Degree
Marion SIMONETTA-MOREAU, MDPhD
First Name & Middle Initial & Last Name & Degree
Claire THALAMAS, MD
First Name & Middle Initial & Last Name & Degree
Angélique GERDELAT-MAS, MD
First Name & Middle Initial & Last Name & Degree
Fabienne CALVAS, MD
First Name & Middle Initial & Last Name & Degree
François CHOLLET, MDPhD
First Name & Middle Initial & Last Name & Degree
Jean-François ALBUCHER, MD
First Name & Middle Initial & Last Name & Degree
Nicolas RAPOSO, MD
First Name & Middle Initial & Last Name & Degree
Isabelle Loubinoux, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17389628
Citation
Loubinoux I, Dechaumont-Palacin S, Castel-Lacanal E, De Boissezon X, Marque P, Pariente J, Albucher JF, Berry I, Chollet F. Prognostic value of FMRI in recovery of hand function in subcortical stroke patients. Cereb Cortex. 2007 Dec;17(12):2980-7. doi: 10.1093/cercor/bhm023. Epub 2007 Mar 26.
Results Reference
background
PubMed Identifier
17265041
Citation
Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. doi: 10.1007/s00221-006-0844-5. Epub 2007 Jan 31.
Results Reference
background
PubMed Identifier
19060132
Citation
Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5.
Results Reference
background
PubMed Identifier
19072894
Citation
Conchou F, Loubinoux I, Castel-Lacanal E, Le Tinnier A, Gerdelat-Mas A, Faure-Marie N, Gros H, Thalamas C, Calvas F, Berry I, Chollet F, Simonetta Moreau M. Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study. Hum Brain Mapp. 2009 Aug;30(8):2542-57. doi: 10.1002/hbm.20690.
Results Reference
background
PubMed Identifier
19286579
Citation
Celnik P, Paik NJ, Vandermeeren Y, Dimyan M, Cohen LG. Effects of combined peripheral nerve stimulation and brain polarization on performance of a motor sequence task after chronic stroke. Stroke. 2009 May;40(5):1764-71. doi: 10.1161/STROKEAHA.108.540500. Epub 2009 Mar 12.
Results Reference
background
PubMed Identifier
12906948
Citation
Uy J, Ridding MC. Increased cortical excitability induced by transcranial DC and peripheral nerve stimulation. J Neurosci Methods. 2003 Aug 15;127(2):193-7. doi: 10.1016/s0165-0270(03)00142-0.
Results Reference
background
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived
Links:
URL
http://www.chu-toulouse.fr/-c-i-c-centre-d-investigation
Description
Clinical Investigation Center Toulouse France

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Combined tDCS+PNS After Acute Stroke

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