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The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke
Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.
In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.
However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.
With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tdcs / CIMT | Experimental | Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT) |
|
| Sham stimulation / CIMT | Sham Comparator | Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device |
| ||
| Constraint-Induced Movement Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence measured by Barthel Index | Change for functional independence at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive dysfunction (Montreal Cognitive Assessment) | Baseline (week 1) and Endpoint (week 4) | |
| Executive functions (Victoria version of the Stroop Color and Word Test) | Baseline (week 1) and Endpoint (week 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suellen Andrade | Contact | suellenandrade@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of ParaÃba,Department of Psychology | João Pessoa | ParaÃba | 58051-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | 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. | |
| 26822418 | Derived | Andrade SM, Santos NA, Fernandez-Calvo B, Boggio PS, Oliveira EA, Ferreira JJ, Sobreira A, Morgan F, Medeiros G, Cavalcanti GS, Gadelha ID, Duarte J, Marrocos J, Silva MA, Rufino T, Nobrega SR. Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial. Trials. 2016 Jan 28;17:56. doi: 10.1186/s13063-016-1186-7. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000098483 | Constraint Induced Movement Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Behavioral |
|
| Placebo | Other |
|
| Attention and Working Memory (Digit span subtest) | Baseline (week 1) and Endpoint (week 4) |
| Spasticity | Baseline, Week 2 and Week 4 |
| Muscle strength | Baseline, Week 2 and Week 4 |
| Balance | Baseline, Week 2 and Week 4 |
| Posture | Baseline, Week 2 and Week 4 |
| Fear of falling during daily life activities | Baseline, Week 2 and Week 4 |
| Upper limb function | Baseline, Week 2 and Week 4 |
| Quality of life | Baseline, Week 2 and Week 4 |
| Lower limb function | Baseline, Week 2 and Week 4 |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |