First Ever Clinical Stroke, Ischemic Stroke, Persistent Hemiparesis of Upper Extremity, Subacute Phase
Conditions
Keywords
hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy
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.
Interventions
PROCEDUREtranscranial 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
PROCEDURESham 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
PROCEDURESham stimulation
Sham stimulation for 30 seconds on 15 days during 6 weeks
Sponsors
Insel Gruppe AG, University Hospital Bern
Clinica Hildebrand Brissago
Advisory Board Research Ente Ospedaliero Cantonale
Dr. med. Carlo Cereda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment Upper Extremity | 6 weeks | Investigator administered questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | 3 weeks | Investigator administered questionnaire |
| Ashworth scale | 3 weeks | Investigator administered questionnaire |
| Fugl-Meyer Assessment Upper Extremity | 3 weeks | Investigator administered questionnaire |
| Grip strength | 3 weeks | Jamar Hydraulic Hand dynamometer |
| Hamilton depression Rating scale | 6 weeks | Patient administered questionnaire |
| Test of Upper Limb Apraxia (TULIA) | 6 weeks | investigator administered questionnaire |
Countries
Switzerland
Contacts
Primary ContactCarlo Cereda, MD
Backup ContactPaolo Rossi, MD
Outcome results
None listed