Acute Ischaemic Stroke Clinical Trial
Official title:
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
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan) | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | Fondation de l'Avenir |
France,
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. Epub 2007 Jan 31. — View 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. — View 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. — View 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. — View 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. Epub 2007 Mar 26. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Jebsen Taylor test | 5-15-30 days | No | |
| Secondary | Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS) | 5-15-30 days | No |
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