Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)
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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Sao Paulo, Brasilien, 05652-901
- Danielle Boasquevisque
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Exclusion Criteria:
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Active tDCS+ Physical Therapy
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)
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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).
Physical therapy will be administered for 60 minutes
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Sham Comparator: Sham tDCS+Physical Therapy
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) |
In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Safety of the intervention as assessed by frequency of adverse events
Tidsram: 2 weeks
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frequency of adverse events in the active and sham arms
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2 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Improvement post treatment as measured by the Modified Rankin Scale
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the NIH Stroke Scale
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Stroke Impact Scale
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Modified Ashworth Scale
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Motor Activity Log
Tidsram: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Montreal Cognitive Assessment Test
Tidsram: 2 weeks and 14 weeks
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No cognitive deterioration post treatment
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2 weeks and 14 weeks
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Structural Connectivity as measured by diffusion tensor imaging analysis
Tidsram: 2 weeks
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Improvement post treatment
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2 weeks
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Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Tidsram: 2 weeks
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Improvement post treatment
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2 weeks
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Improvement post treatment as measured by the Barthel index
Tidsram: 2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Safety of the intervention as assessed by frequency of adverse events
Tidsram: 14 weeks
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frequency of adverse events in the active and sham arms
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14 weeks
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Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Tidsram: 2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 225014
Plan för individuella deltagardata (IPD)
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