Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Liege
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Wolf Motor Function Test Change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The device is preprogrammed by a third party non participating in any element in the study. They then chose (using opaque envelopes) the treatment code for each participant.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Woman or man
- •Between 18 and 80 years old
- •First ever stroke
- •Capable of signing the consent form
Exclusion Criteria
- •One on the TSST (in high and relatively high risk sections)
- •Previous neurological or orthopedic pathologies affecting limbs
- •Cognitive deficits
Arms & Interventions
Anodal tDCS
Patients will receive 20min anodal tDCS
Intervention: tDCS (Device)
Sham tDCS
Patients will receive 20 minutes of Sham anodal tDCS
Intervention: tDCS (Device)
Outcomes
Primary Outcomes
Wolf Motor Function Test Change
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
Investigators
Bornheim Stephen
Assistant Professor
University of Liege