Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
NCT ID: NCT01644929
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2013-03-31
2018-02-28
Brief Summary
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We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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1 tDCS-Sham
tDC stimulation for 3 weeks, then cross-over to sham stimulation
transcranial direct current stimulation (tDCS)
Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
2 Sham-tDCS
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
Sham stimulation, then tDCS
Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
3 Sham-Sham
Treatment for 6 weeks daily with sham stimulation
Sham stimulation
Sham stimulation for 30 seconds on 15 days during 6 weeks
Interventions
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transcranial direct current stimulation (tDCS)
Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
Sham stimulation, then tDCS
Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
Sham stimulation
Sham stimulation for 30 seconds on 15 days during 6 weeks
Eligibility Criteria
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Inclusion Criteria
2. Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
3. Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required
4. No UE injury or conditions that limited use prior to the stroke.
5. The patient is \>18 years old.
6. The patient has subscribed the informed consent
Exclusion Criteria
2. Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
3. Severe pain in the affected upper limb (\>=8 on the shoulder item of the "joint pain during passive motion" of the Fugl-Meyer Assessment Upper Extremity)
4. Further stroke or other significant medical complication during the study
5. Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
6. Important aphasia that would impair the understanding and performance of the assessment scales
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Clinica Hildebrand Brissago
OTHER
Advisory Board Research Ente Ospedaliero Cantonale
UNKNOWN
Dr. med. Carlo Cereda
OTHER_GOV
Responsible Party
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Dr. med. Carlo Cereda
Capo clinica
Principal Investigators
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Carlo Cereda, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Regionale di Lugano - Civico
Locations
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Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
Bern, , Switzerland
Clinica Hildebrand, Centro di riabilitazione Brissago
Brissago, , Switzerland
HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
Zihlschlacht, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
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.
Related Links
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Link to the hospital coordinating the study
Link to the hospital participating in the study
Link to the clinic participating in the study
Other Identifiers
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EOC.NSI.11.02
Identifier Type: -
Identifier Source: org_study_id