Combined tDCS+PNS After Acute Stroke

NCT01207336 | Completed Phase 2 DMC

• 2 other identifiers: C09-272009-A01153-54
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Ischaemic Stroke

Keywords

stroke; rehabilitation; transcranial direct current stimulation; nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Jebsen Taylor test

  5-15-30 days

Secondary Outcomes (1)

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

  5-15-30 days

Interventions

combined transcranial direct current stimulation and electrical peripheral nerve stimulation DEVICE

tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS \<15 age 35-85 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

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

Toulouse, 31059, France

Location

Related Publications (7)

• 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.

  PMID: 17389628 BACKGROUND

• 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.

  PMID: 17265041 BACKGROUND

• 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.

  PMID: 19060132 BACKGROUND

• 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.

  PMID: 19072894 BACKGROUND

• 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.

  PMID: 19286579 BACKGROUND

• 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.

  PMID: 12906948 BACKGROUND

• 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.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marion SIMONETTA-MOREAU, MDPhD

  Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, France

  STUDY DIRECTOR

• François CHOLLET, MDPhD

  Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: September 1, 2010
• Primary Completion: August 30, 2012
• Study Completion: August 30, 2012
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

FR (1)