Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke

Not Applicable

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

• Registration Number: NCT01644929
• Lead Sponsor: Dr. med. Carlo Cereda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-19
• Study Start: 2013-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 tDCS-Sham	transcranial direct current stimulation (tDCS)	tDC stimulation for 3 weeks, then cross-over to sham stimulation
3 Sham-Sham	Sham stimulation	Treatment for 6 weeks daily with sham stimulation
2 Sham-tDCS	Sham stimulation, then tDCS	Sham stimulation for 3 weeks, then cross over to tDCS stimulation

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment Upper Extremity	6 weeks	Investigator administered questionnaire

Secondary Outcome Measures

Name	Time	Method
Ashworth scale	6 months	Investigator administered questionnaire
Hamilton depression Rating scale	6 months	Patient administered questionnaire
Fugl-Meyer Assessment Upper Extremity	6 months	Investigator administered questionnaire
Grip strength	6 months	Jamar Hydraulic Hand dynamometer
Barthel Index	6 months	Investigator administered questionnaire
Test of Upper Limb Apraxia (TULIA)	6 months	investigator administered questionnaire

Trial Locations

Locations (3)

HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum; 🇨🇭 Zihlschlacht, Switzerland

Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation; 🇨🇭 Bern, Switzerland

Clinica Hildebrand, Centro di riabilitazione Brissago; 🇨🇭 Brissago, Switzerland