Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients
- Conditions
- Stroke, Acute
- Interventions
- Device: tDCS
- Registration Number
- NCT03888209
- Lead Sponsor
- University of Liege
- Brief Summary
Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS.
Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.
- Detailed Description
Recruitment :
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Woman or man
- Between 18 and 80 years old
- First ever stroke
- Capable of signing the consent form
- One on the TSST (in high and relatively high risk sections)
- Previous neurological or orthopedic pathologies affecting limbs
- Cognitive deficits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham tDCS tDCS Patients will receive 20 minutes of Sham anodal tDCS Anodal tDCS tDCS Patients will receive 20min anodal tDCS
- Primary Outcome Measures
Name Time Method Wolf Motor Function Test Change 48 hours post onset, 7, 14, 21 and 28 days post onset, 3 and 6 months post onset and 1 year post onset Functional outcome of the paretic limb
Semmes Weinstein Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Monofilament sensory test
Timed up and go Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset walking test
10 meter walk test Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Walking speed test
- Secondary Outcome Measures
Name Time Method Trunk impairment scale Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset balance test, the higher the score the higher the better the patient is
HADS Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is
Fugl Meyer Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Upper and lower limb motor outcomes, the higher the score the higher the better the patient is
Stroke impact scale Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is
4 square step test Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Balance test, the higher the score the higher the worse the patient is
Tardieu spasticity scale Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset spasticity scale, the higher the score the higher the spasticity
Berg Balance scale Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Balance test, the higher the score the higher the score, the better the patient is
Postural assessement scale Change 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset Balance test, the higher the score the higher the better the patient is
Trial Locations
- Locations (1)
Liege Univeristy Hospital
🇧🇪Liege, Belgium