ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01644929
Recruitment Status : Recruiting
First Posted : July 19, 2012
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
Advisory Board Research Ente Ospedaliero Cantonale
Information provided by (Responsible Party):
Dr. med. Carlo Cereda, Ospedale Civico, Lugano

July 17, 2012
July 19, 2012
September 19, 2017
March 2013
February 2018   (Final data collection date for primary outcome measure)
Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 weeks ]
Investigator administered questionnaire
Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 months ]
Investigator administered questionnaire
Complete list of historical versions of study NCT01644929 on ClinicalTrials.gov Archive Site
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 months ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 6 weeks ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 6 months ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 6 weeks ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 6 months ]
    Investigator administered questionnaire
  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 weeks ]
    investigator administered questionnaire
  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 months ]
    investigator administered questionnaire
  • Grip strength [ Time Frame: 3 weeks ]
    Jamar Hydraulic Hand dynamometer
  • Grip strength [ Time Frame: 6 weeks ]
    Jamar Hydraulic Hand dynamometer
  • Grip strength [ Time Frame: 6 months ]
    Jamar Hydraulic Hand dynamometer
  • Hamilton depression Rating scale [ Time Frame: 6 weeks ]
    Patient administered questionnaire
  • Hamilton depression Rating scale [ Time Frame: 6 months ]
    Patient administered questionnaire
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Fugl-Meyer Assessment Upper Extremity [ Time Frame: 6 weeks ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 6 weeks ]
    Investigator administered questionnaire
  • Barthel Index [ Time Frame: 6 months ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 3 weeks ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 6 weeks ]
    Investigator administered questionnaire
  • Ashworth scale [ Time Frame: 6 months ]
    Investigator administered questionnaire
  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 weeks ]
    investigator administered questionnaire
  • Test of Upper Limb Apraxia (TULIA) [ Time Frame: 6 months ]
    investigator administered questionnaire
  • Grip strength [ Time Frame: 3 weeks ]
    Jamar Hydraulic Hand dynamometer
  • Grip strength [ Time Frame: 6 weeks ]
    Jamar Hydraulic Hand dynamometer
  • Grip strength [ Time Frame: 6 months ]
    Jamar Hydraulic Hand dynamometer
  • Hamilton depression Rating scale [ Time Frame: 6 weeks ]
    Patient administered questionnaire
  • Hamilton depression Rating scale [ Time Frame: 6 months ]
    Patient administered questionnaire
Not Provided
Not Provided
 
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
  • First Ever Clinical Stroke
  • Ischemic Stroke
  • Subacute Phase
  • Persistent Hemiparesis of Upper Extremity
  • 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
  • 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
  • Procedure: Sham stimulation
    Sham stimulation for 30 seconds on 15 days during 6 weeks
  • Experimental: 1 tDCS-Sham
    tDC stimulation for 3 weeks, then cross-over to sham stimulation
    Intervention: Procedure: transcranial direct current stimulation (tDCS)
  • Experimental: 2 Sham-tDCS
    Sham stimulation for 3 weeks, then cross over to tDCS stimulation
    Intervention: Procedure: Sham stimulation, then tDCS
  • Sham Comparator: 3 Sham-Sham
    Treatment for 6 weeks daily with sham stimulation
    Intervention: Procedure: Sham stimulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Same as current
February 2018
February 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Carlo Cereda, MD +41 91 811 66 91 Carlo.Cereda@eoc.ch
Contact: Paolo Rossi, MD +41 091 786 86 86 paolo.rossi@clinica-hildebrand.ch
Switzerland
 
 
NCT01644929
EOC.NSI.11.02
Yes
Not Provided
Not Provided
Dr. med. Carlo Cereda, Ospedale Civico, Lugano
Dr. med. Carlo Cereda
  • University Hospital Inselspital, Berne
  • CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
  • Advisory Board Research Ente Ospedaliero Cantonale
Principal Investigator: Carlo Cereda, MD Ospedale Regionale di Lugano - Civico
Ospedale Civico, Lugano
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP