- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01644929
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Carlo Cereda, MD
- Telefonnummer: +41 91 811 66 91
- E-post: Carlo.Cereda@eoc.ch
Studer Kontakt Backup
- Navn: Paolo Rossi, MD
- Telefonnummer: +41 091 786 86 86
- E-post: paolo.rossi@clinica-hildebrand.ch
Studiesteder
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Bern, Sveits, 3010
- Tilbaketrukket
- Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
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Brissago, Sveits, 6614
- Rekruttering
- Clinica Hildebrand, Centro di riabilitazione Brissago
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Ta kontakt med:
- Paolo Rossi, MD
- Telefonnummer: +41 91 786 86 86
- E-post: p.rossi@clinica-hildebrand.ch
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Hovedetterforsker:
- Paolo Rossi, MD
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Zihlschlacht, Sveits, 8588
- Avsluttet
- HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Eksperimentell: 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-komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fugl-Meyer Assessment Upper Extremity
Tidsramme: 6 weeks
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Investigator administered questionnaire
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6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fugl-Meyer Assessment Upper Extremity
Tidsramme: 3 weeks
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Investigator administered questionnaire
|
3 weeks
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Fugl-Meyer Assessment Upper Extremity
Tidsramme: 6 months
|
Investigator administered questionnaire
|
6 months
|
Barthel Index
Tidsramme: 3 weeks
|
Investigator administered questionnaire
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3 weeks
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Barthel Index
Tidsramme: 6 weeks
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Investigator administered questionnaire
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6 weeks
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Barthel Index
Tidsramme: 6 months
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Investigator administered questionnaire
|
6 months
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Ashworth scale
Tidsramme: 3 weeks
|
Investigator administered questionnaire
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3 weeks
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Ashworth scale
Tidsramme: 6 weeks
|
Investigator administered questionnaire
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6 weeks
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Ashworth scale
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6 months
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investigator administered questionnaire
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6 months
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Grip strength
Tidsramme: 3 weeks
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Jamar Hydraulic Hand dynamometer
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3 weeks
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Grip strength
Tidsramme: 6 weeks
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Jamar Hydraulic Hand dynamometer
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6 weeks
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Grip strength
Tidsramme: 6 months
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Jamar Hydraulic Hand dynamometer
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6 months
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Hamilton depression Rating scale
Tidsramme: 6 weeks
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Patient administered questionnaire
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6 weeks
|
Hamilton depression Rating scale
Tidsramme: 6 months
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Patient administered questionnaire
|
6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Carlo Cereda, MD, Ospedale Regionale di Lugano - Civico
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EOC.NSI.11.02
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