Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke (RECOMBINE)
Primary Purpose
First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sham stimulation, then tDCS
Sham stimulation
Sponsored by
About this trial
This is an interventional other trial for First Ever Clinical Stroke focused on measuring hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy
Eligibility Criteria
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
Sites / Locations
- Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
- Clinica Hildebrand, Centro di riabilitazione BrissagoRecruiting
- HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
1 tDCS-Sham
2 Sham-tDCS
3 Sham-Sham
Arm Description
tDC stimulation for 3 weeks, then cross-over to sham stimulation
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
Treatment for 6 weeks daily with sham stimulation
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Secondary Outcome Measures
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Barthel Index
Investigator administered questionnaire
Barthel Index
Investigator administered questionnaire
Barthel Index
Investigator administered questionnaire
Ashworth scale
Investigator administered questionnaire
Ashworth scale
Investigator administered questionnaire
Ashworth scale
Investigator administered questionnaire
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Grip strength
Jamar Hydraulic Hand dynamometer
Grip strength
Jamar Hydraulic Hand dynamometer
Grip strength
Jamar Hydraulic Hand dynamometer
Hamilton depression Rating scale
Patient administered questionnaire
Hamilton depression Rating scale
Patient administered questionnaire
Full Information
NCT ID
NCT01644929
First Posted
July 17, 2012
Last Updated
September 18, 2017
Sponsor
Dr. med. Carlo Cereda
Collaborators
Insel Gruppe AG, University Hospital Bern, CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Advisory Board Research Ente Ospedaliero Cantonale
1. Study Identification
Unique Protocol Identification Number
NCT01644929
Brief Title
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
Acronym
RECOMBINE
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. med. Carlo Cereda
Collaborators
Insel Gruppe AG, University Hospital Bern, CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Advisory Board Research Ente Ospedaliero Cantonale
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase, Persistent Hemiparesis of Upper Extremity
Keywords
hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 tDCS-Sham
Arm Type
Experimental
Arm Description
tDC stimulation for 3 weeks, then cross-over to sham stimulation
Arm Title
2 Sham-tDCS
Arm Type
Experimental
Arm Description
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
Arm Title
3 Sham-Sham
Arm Type
Sham Comparator
Arm Description
Treatment for 6 weeks daily with sham stimulation
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation, then tDCS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation
Intervention Description
Sham stimulation for 30 seconds on 15 days during 6 weeks
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Upper Extremity
Description
Investigator administered questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment Upper Extremity
Description
Investigator administered questionnaire
Time Frame
3 weeks
Title
Fugl-Meyer Assessment Upper Extremity
Description
Investigator administered questionnaire
Time Frame
6 months
Title
Barthel Index
Description
Investigator administered questionnaire
Time Frame
3 weeks
Title
Barthel Index
Description
Investigator administered questionnaire
Time Frame
6 weeks
Title
Barthel Index
Description
Investigator administered questionnaire
Time Frame
6 months
Title
Ashworth scale
Description
Investigator administered questionnaire
Time Frame
3 weeks
Title
Ashworth scale
Description
Investigator administered questionnaire
Time Frame
6 weeks
Title
Ashworth scale
Description
Investigator administered questionnaire
Time Frame
6 months
Title
Test of Upper Limb Apraxia (TULIA)
Description
investigator administered questionnaire
Time Frame
6 weeks
Title
Test of Upper Limb Apraxia (TULIA)
Description
investigator administered questionnaire
Time Frame
6 months
Title
Grip strength
Description
Jamar Hydraulic Hand dynamometer
Time Frame
3 weeks
Title
Grip strength
Description
Jamar Hydraulic Hand dynamometer
Time Frame
6 weeks
Title
Grip strength
Description
Jamar Hydraulic Hand dynamometer
Time Frame
6 months
Title
Hamilton depression Rating scale
Description
Patient administered questionnaire
Time Frame
6 weeks
Title
Hamilton depression Rating scale
Description
Patient administered questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Cereda, MD
Phone
+41 91 811 66 91
Email
Carlo.Cereda@eoc.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Rossi, MD
Phone
+41 091 786 86 86
Email
paolo.rossi@clinica-hildebrand.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Cereda, MD
Organizational Affiliation
Ospedale Regionale di Lugano - Civico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Clinica Hildebrand, Centro di riabilitazione Brissago
City
Brissago
ZIP/Postal Code
6614
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Rossi, MD
Phone
+41 91 786 86 86
Email
p.rossi@clinica-hildebrand.ch
First Name & Middle Initial & Last Name & Degree
Paolo Rossi, MD
Facility Name
HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
City
Zihlschlacht
ZIP/Postal Code
8588
Country
Switzerland
Individual Site Status
Terminated
12. IPD Sharing Statement
Citations:
PubMed Identifier
21068427
Citation
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.
Results Reference
background
PubMed Identifier
33175411
Citation
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.
Results Reference
derived
Links:
URL
http://www.eoc.ch
Description
Link to the hospital coordinating the study
URL
http://neurologie.insel.ch/de/
Description
Link to the hospital participating in the study
URL
http://www.clinica-hildebrand.ch/
Description
Link to the clinic participating in the study
Learn more about this trial
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
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