Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01644929
• Other study ID #: EOC.NSI.11.02
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2012
• Last updated: September 18, 2017
• Start date: March 2013
• Est. completion date: February 2018

Study information

• Verified date: September 2017
• Source: Ospedale Civico, Lugano
• Contact: Carlo Cereda, MD
• Phone: +41 91 811 66 91
• Email: Carlo.Cereda[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• First Ever Clinical Stroke
• Ischemia
• Ischemic Stroke
• Paresis
• Persistent Hemiparesis of Upper Extremity
• Stroke
• Subacute Phase

Intervention

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
• 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 stimulation
Sham stimulation for 30 seconds on 15 days during 6 weeks

Locations

Country	Name	City	State
Switzerland	Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation	Bern
Switzerland	Clinica Hildebrand, Centro di riabilitazione Brissago	Brissago
Switzerland	HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum	Zihlschlacht

Sponsors (4)

Lead Sponsor	Collaborator
Dr. med. Carlo Cereda	Advisory Board Research Ente Ospedaliero Cantonale, CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment Upper Extremity	Investigator administered questionnaire	6 weeks
Secondary	Fugl-Meyer Assessment Upper Extremity	Investigator administered questionnaire	3 weeks
Secondary	Fugl-Meyer Assessment Upper Extremity	Investigator administered questionnaire	6 months
Secondary	Barthel Index	Investigator administered questionnaire	3 weeks
Secondary	Barthel Index	Investigator administered questionnaire	6 weeks
Secondary	Barthel Index	Investigator administered questionnaire	6 months
Secondary	Ashworth scale	Investigator administered questionnaire	3 weeks
Secondary	Ashworth scale	Investigator administered questionnaire	6 weeks
Secondary	Ashworth scale	Investigator administered questionnaire	6 months
Secondary	Test of Upper Limb Apraxia (TULIA)	investigator administered questionnaire	6 weeks
Secondary	Test of Upper Limb Apraxia (TULIA)	investigator administered questionnaire	6 months
Secondary	Grip strength	Jamar Hydraulic Hand dynamometer	3 weeks
Secondary	Grip strength	Jamar Hydraulic Hand dynamometer	6 weeks
Secondary	Grip strength	Jamar Hydraulic Hand dynamometer	6 months
Secondary	Hamilton depression Rating scale	Patient administered questionnaire	6 weeks
Secondary	Hamilton depression Rating scale	Patient administered questionnaire	6 months

External Links

•   Link to the clinic participating in the study
•   Link to the hospital coordinating the study
•   Link to the hospital participating in the study