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

Recruiting

Phase N/A Results N/A

Update History

20 Sep '17
The Summary of Purpose was updated.
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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.
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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.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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
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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
A location was updated in Bern.
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The overall status was updated to "Withdrawn" at Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation.
A location was updated in Zihlschlacht.
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The overall status was updated to "Terminated" at HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum.
12 Apr '14
A location was updated in Bern.
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The overall status was updated to "Withdrawn" at Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation.
A location was updated in Brissago.
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The overall status was updated to "Recruiting" at Clinica Hildebrand, Centro di riabilitazione Brissago.
A location was updated in Zihlschlacht.
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The overall status was updated to "Terminated" at HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum.