Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients
NCT ID: NCT03888209
Last Updated: 2019-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-03-31
2020-08-31
Brief Summary
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Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.
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Detailed Description
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Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits
• Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A).
Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday).
In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received.
• Evaluations and measurements:
Patients will be required to perform functional tests of the upper limb (Wolf Motor Function Test (WMFT)), filmed and timed, a test of spasticity (Tardieu) as well as to answer certain questionnaires concerning their perception of the evolution of the disease and their disability (Stroke Impact Scale, Barthel Index), their emotional state (HADS), if they have experienced side effects, sensitivity test with monofilaments or Semmes and Weinstein test, the Fugl Meyer, the timed up and go, the test of 10m, the four step square test, the berg balance scale, the postural assessment scale and the trunk impairment scale. These evaluations will take place at Day 0 (corresponding to the first day after the 48h of strict bedtime), Day 7, 15, 30, 90, 6 months and 1 year. They will be done in two stages, on two successive days, so as not to exhaust the patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anodal tDCS
Patients will receive 20min anodal tDCS
tDCS
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
Sham tDCS
Patients will receive 20 minutes of Sham anodal tDCS
tDCS
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
Interventions
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tDCS
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 80 years old
* First ever stroke
* Capable of signing the consent form
Exclusion Criteria
* Previous neurological or orthopedic pathologies affecting limbs
* Cognitive deficits
18 Years
80 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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Bornheim Stephen
Assistant Professor
Principal Investigators
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Stephen Bornheim, Msc
Role: PRINCIPAL_INVESTIGATOR
Liege Univeristy Hospital
Locations
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Liege Univeristy Hospital
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Stephen Bornheim, Msc
Role: primary
Other Identifiers
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2016-287
Identifier Type: -
Identifier Source: org_study_id
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