Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke (RECOMBINE)
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Bern, Schweiz, 3010
- Indragen
- Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
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Brissago, Schweiz, 6614
- Rekrytering
- Clinica Hildebrand, Centro di riabilitazione Brissago
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Kontakt:
- Paolo Rossi, MD
- Telefonnummer: +41 91 786 86 86
- E-post: p.rossi@clinica-hildebrand.ch
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Huvudutredare:
- Paolo Rossi, MD
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Zihlschlacht, Schweiz, 8588
- Avslutad
- HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
- Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
- 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
- No UE injury or conditions that limited use prior to the stroke.
- The patient is >18 years old.
- The patient has subscribed the informed consent
Exclusion Criteria:
- History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
- Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
- 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)
- Further stroke or other significant medical complication during the study
- Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
- Important aphasia that would impair the understanding and performance of the assessment scales
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 1 tDCS-Sham
tDC stimulation for 3 weeks, then cross-over to sham stimulation
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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
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Experimentell: 2 Sham-tDCS
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
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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
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Sham Comparator: 3 Sham-Sham
Treatment for 6 weeks daily with sham stimulation
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Sham stimulation for 30 seconds on 15 days during 6 weeks
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Fugl-Meyer Assessment Upper Extremity
Tidsram: 6 weeks
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Investigator administered questionnaire
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6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fugl-Meyer Assessment Upper Extremity
Tidsram: 3 weeks
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Investigator administered questionnaire
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3 weeks
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Fugl-Meyer Assessment Upper Extremity
Tidsram: 6 months
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Investigator administered questionnaire
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6 months
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Barthel Index
Tidsram: 3 weeks
|
Investigator administered questionnaire
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3 weeks
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Barthel Index
Tidsram: 6 weeks
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Investigator administered questionnaire
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6 weeks
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Barthel Index
Tidsram: 6 months
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Investigator administered questionnaire
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6 months
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Ashworth scale
Tidsram: 3 weeks
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Investigator administered questionnaire
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3 weeks
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Ashworth scale
Tidsram: 6 weeks
|
Investigator administered questionnaire
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6 weeks
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Ashworth scale
Tidsram: 6 months
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Investigator administered questionnaire
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6 months
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Test of Upper Limb Apraxia (TULIA)
Tidsram: 6 weeks
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investigator administered questionnaire
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6 weeks
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Test of Upper Limb Apraxia (TULIA)
Tidsram: 6 months
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investigator administered questionnaire
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6 months
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Grip strength
Tidsram: 3 weeks
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Jamar Hydraulic Hand dynamometer
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3 weeks
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Grip strength
Tidsram: 6 weeks
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Jamar Hydraulic Hand dynamometer
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6 weeks
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Grip strength
Tidsram: 6 months
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Jamar Hydraulic Hand dynamometer
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6 months
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Hamilton depression Rating scale
Tidsram: 6 weeks
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Patient administered questionnaire
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6 weeks
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Hamilton depression Rating scale
Tidsram: 6 months
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Patient administered questionnaire
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6 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Carlo Cereda, MD, Ospedale Regionale di Lugano - Civico
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EOC.NSI.11.02
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