Acute Ischaemic Stroke
Conditions
Keywords
stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation
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
Interventions
DEVICEcombined transcranial direct current stimulation and electrical peripheral nerve stimulation
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
DEVICECombined transcranial placebo cortical stimulation (placebo tDCS)
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Fondation de l'Avenir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Jebsen Taylor test | 5-15-30 days |
Secondary
| Measure | Time frame |
|---|---|
| Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS) | 5-15-30 days |
Countries
France
Contacts
STUDY_DIRECTORMarion SIMONETTA-MOREAU, MDPhD
Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, France
PRINCIPAL_INVESTIGATORFrançois CHOLLET, MDPhD
Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France
Outcome results
None listed