Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke (RECOMBINE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ospedale Civico, Lugano
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Helios Klinik Zihlschlacht
Clinica Hildebrand Brissago
Advisory Board Research Ente Ospedaliero Cantonale
Information provided by (Responsible Party):
Dr. med. Carlo Cereda, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier:
NCT01644929
First received: July 17, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
First Ever Clinical Stroke
Ischemic Stroke
Subacute Phase
Persistent Hemiparesis of Upper Extremity
Procedure: transcranial direct current stimulation (tDCS)
Procedure: Sham stimulation, then tDCS
Procedure: Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study

Resource links provided by NLM:


Further study details as provided by Ospedale Civico, Lugano:

Primary Outcome Measures:
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire


Secondary Outcome Measures:
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Barthel Index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Barthel Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Barthel Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Ashworth scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Ashworth scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Ashworth scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Investigator administered questionnaire

  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    investigator administered questionnaire

  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    investigator administered questionnaire

  • Grip strength [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Jamar Hydraulic Hand dynamometer

  • Grip strength [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Jamar Hydraulic Hand dynamometer

  • Grip strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Jamar Hydraulic Hand dynamometer

  • Hamilton depression Rating scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patient administered questionnaire

  • Hamilton depression Rating scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient administered questionnaire


Estimated Enrollment: 36
Study Start Date: March 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 tDCS-Sham
tDC stimulation for 3 weeks, then cross-over to sham stimulation
Procedure: 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
Experimental: 2 Sham-tDCS
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
Procedure: 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 Comparator: 3 Sham-Sham
Treatment for 6 weeks daily with sham stimulation
Procedure: Sham stimulation
Sham stimulation for 30 seconds on 15 days during 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
  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:

  1. History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644929

Contacts
Contact: Carlo Cereda, MD +41 91 811 66 91 Carlo.Cereda@eoc.ch
Contact: René Müri, MD +41 31 632 30 83 rene.mueri@insel.ch

Locations
Switzerland
Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation Recruiting
Bern, Switzerland, 3010
Contact: René Müri, MD    +41 31 632 30 83    rene.mueri@insel.ch   
Principal Investigator: René Müri, MD         
Clinica Hildebrand, Centro di riabilitazione Brissago Recruiting
Brissago, Switzerland, 6614
Contact: Fabio M Conti, MD    +41 91 786 86 86    f.conti@clinica-hildebrand.ch   
Principal Investigator: Fabio M Conti, MD         
HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum Recruiting
Zihlschlacht, Switzerland, 8588
Contact: Daniel Zutter, MD    +41 71 424 30 02    daniel.zutter@helios-kliniken.ch   
Contact: Roul Schweinfurther, M.A. Sport Science    +41 71 424 31 18    r.schweinfurther@rehaklinik-zihlschlacht.ch   
Principal Investigator: Daniel Zutter, MD         
Sub-Investigator: Matthias Oechsner, MD         
Sponsors and Collaborators
Dr. med. Carlo Cereda
University Hospital Inselspital, Berne
Helios Klinik Zihlschlacht
Clinica Hildebrand Brissago
Advisory Board Research Ente Ospedaliero Cantonale
Investigators
Principal Investigator: Carlo Cereda, MD Ospedale Regionale di Lugano - Civico
Principal Investigator: René Müri, MD Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
  More Information

Additional Information:
Publications:
Responsible Party: Dr. med. Carlo Cereda, Capo clinica, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier: NCT01644929     History of Changes
Other Study ID Numbers: EOC.NSI.11.02
Study First Received: July 17, 2012
Last Updated: April 9, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Ospedale Civico, Lugano:
hemiparesis
bihemispheric transcranial direct current stimulation
ischemic stroke
subacute
rehabilitation
physiotherapy
ergotherapy

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Ischemia
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014