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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Clinica Hildebrand Brissago | OTHER |
| Advisory Board Research Ente Ospedaliero Cantonale | UNKNOWN |
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Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 tDCS-Sham | Experimental | tDC stimulation for 3 weeks, then cross-over to sham stimulation |
|
| 2 Sham-tDCS | Experimental | Sham stimulation for 3 weeks, then cross over to tDCS stimulation |
|
| 3 Sham-Sham | Sham Comparator | Treatment for 6 weeks daily with sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire | 3 weeks |
| Fugl-Meyer Assessment Upper Extremity | Investigator administered questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Cereda, MD | Contact | +41 91 811 66 91 | Carlo.Cereda@eoc.ch | |
| Paolo Rossi, MD | Contact | +41 091 786 86 86 | paolo.rossi@clinica-hildebrand.ch |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Cereda, MD | Ospedale Regionale di Lugano - Civico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation | Withdrawn | Bern | 3010 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21068427 | Background | 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. | |
| 33175411 | Derived | 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. |
| Label | URL |
|---|---|
| Link to the hospital coordinating the study | View source |
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| Sham stimulation, then tDCS | Procedure | 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 | Procedure | Sham stimulation for 30 seconds on 15 days during 6 weeks |
|
| 6 months |
| Barthel Index | Investigator administered questionnaire | 3 weeks |
| Barthel Index | Investigator administered questionnaire | 6 weeks |
| Barthel Index | Investigator administered questionnaire | 6 months |
| Ashworth scale | Investigator administered questionnaire | 3 weeks |
| Ashworth scale | Investigator administered questionnaire | 6 weeks |
| Ashworth scale | Investigator administered questionnaire | 6 months |
| Test of Upper Limb Apraxia (TULIA) | investigator administered questionnaire | 6 weeks |
| Test of Upper Limb Apraxia (TULIA) | investigator administered questionnaire | 6 months |
| Grip strength | Jamar Hydraulic Hand dynamometer | 3 weeks |
| Grip strength | Jamar Hydraulic Hand dynamometer | 6 weeks |
| Grip strength | Jamar Hydraulic Hand dynamometer | 6 months |
| Hamilton depression Rating scale | Patient administered questionnaire | 6 weeks |
| Hamilton depression Rating scale | Patient administered questionnaire | 6 months |
| Clinica Hildebrand, Centro di riabilitazione Brissago |
| Recruiting |
| Brissago |
| 6614 |
| Switzerland |
|
| HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum | Terminated | Zihlschlacht | 8588 | Switzerland |
| Link to the hospital participating in the study | View source |
| Link to the clinic participating in the study | View source |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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