Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients (tDCS ASAP)
Primary Purpose
Stroke, Acute
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tDCS
Sponsored by

About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring tDCS, WMFT, Semmes Weinstein, Acute stroke
Eligibility Criteria
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
Sites / Locations
- Liege Univeristy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal tDCS
Sham tDCS
Arm Description
Patients will receive 20min anodal tDCS
Patients will receive 20 minutes of Sham anodal tDCS
Outcomes
Primary Outcome Measures
Wolf Motor Function Test Change
Functional outcome of the paretic limb
Semmes Weinstein Change
Monofilament sensory test
Timed up and go Change
walking test
10 meter walk test Change
Walking speed test
Secondary Outcome Measures
Tardieu spasticity scale Change
spasticity scale, the higher the score the higher the spasticity
Stroke impact scale Change
Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is
HADS Change
Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is
Fugl Meyer Change
Upper and lower limb motor outcomes, the higher the score the higher the better the patient is
4 square step test Change
Balance test, the higher the score the higher the worse the patient is
Berg Balance scale Change
Balance test, the higher the score the higher the score, the better the patient is
Postural assessement scale Change
Balance test, the higher the score the higher the better the patient is
Trunk impairment scale Change
balance test, the higher the score the higher the better the patient is
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03888209
Brief Title
Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients
Acronym
tDCS ASAP
Official Title
Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
tDCS, WMFT, Semmes Weinstein, Acute stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, triple blind, sham controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
Patients will receive 20min anodal tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Patients will receive 20 minutes of Sham anodal tDCS
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
Non invasive brain stimulation
Intervention Description
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
Primary Outcome Measure Information:
Title
Wolf Motor Function Test Change
Description
Functional outcome of the paretic limb
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
Title
Semmes Weinstein Change
Description
Monofilament sensory test
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
Title
Timed up and go Change
Description
walking test
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
Title
10 meter walk test Change
Description
Walking speed test
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
Secondary Outcome Measure Information:
Title
Tardieu spasticity scale Change
Description
spasticity scale, the higher the score the higher the spasticity
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
Title
Stroke impact scale Change
Description
Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is
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
Title
HADS Change
Description
Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is
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
Title
Fugl Meyer Change
Description
Upper and lower limb motor outcomes, the higher the score the higher the better the patient is
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
Title
4 square step test Change
Description
Balance test, the higher the score the higher the worse the patient is
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
Title
Berg Balance scale Change
Description
Balance test, the higher the score the higher the score, the better the patient is
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
Title
Postural assessement scale Change
Description
Balance test, the higher the score the higher the better the patient is
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
Title
Trunk impairment scale Change
Description
balance test, the higher the score the higher the better the patient is
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Bornheim, Msc
Phone
003243663577
Email
stephen.bornheim@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Kaux, Phd, MD
Phone
003243668241
Email
jfkaux@uliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Bornheim, Msc
Organizational Affiliation
Liege Univeristy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liege Univeristy Hospital
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Bornheim, Msc
12. IPD Sharing Statement
Plan to Share IPD
No
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Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients
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