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Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS+ Physical Therapy | Active Comparator | Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
|
| Sham tDCS+Physical Therapy | Sham Comparator | Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the intervention as assessed by frequency of adverse events | frequency of adverse events in the active and sham arms | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement post treatment as measured by the Modified Rankin Scale | Improvement post treatment | 2 weeks and 14 weeks |
| Improvement post treatment as measured by the NIH Stroke Scale | Improvement post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana B Conforto, MD Phd | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danielle Boasquevisque | São Paulo | 05652-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38922218 | Derived | Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024. | |
| 33175411 | Derived |
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Deidentified imaging data will be shared with collaborators
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical Therapy | Other | Physical therapy will be administered for 60 minutes |
|
| Sham tDCS | Device | In sham tDCS, no current will be delivered through the tDCS device. |
|
| 2 weeks and 14 weeks |
| Improvement post treatment as measured by the Stroke Impact Scale | Improvement post treatment | 2 weeks and 14 weeks |
| Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke | Improvement post treatment | 2 weeks and 14 weeks |
| Improvement post treatment as measured by the Modified Ashworth Scale | Improvement post treatment | 2 weeks and 14 weeks |
| Improvement post treatment as measured by the Motor Activity Log | Improvement post treatment | 2 weeks and 14 weeks |
| Montreal Cognitive Assessment Test | No cognitive deterioration post treatment | 2 weeks and 14 weeks |
| Structural Connectivity as measured by diffusion tensor imaging analysis | Improvement post treatment | 2 weeks |
| Functional Connectivity as measured by resting-state functional magnetic imaging analysis | Improvement post treatment | 2 weeks |
| Improvement post treatment as measured by the Barthel index | Improvement post treatment | 2 week and 14 weeks |
| Safety of the intervention as assessed by frequency of adverse events | frequency of adverse events in the active and sham arms | 14 weeks |
| Improvement post treatment as measured by Pittsburgh Sleep Quality Index | Improvement post treatment | 2 week and 14 weeks |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |