Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients (tDCS ASAP)

Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?

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.

Study Overview

• Status: Unknown
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: tDCS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Recruiting
    • Liege Univeristy Hospital
    • Contact: Stephen Bornheim, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal tDCS; Patients will receive 20min anodal tDCS	Device: tDCS; 20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham; Other Names: Non invasive brain stimulation
Sham Comparator: Sham tDCS; Patients will receive 20 minutes of Sham anodal tDCS	Device: tDCS; 20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham; Other Names: Non invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test Change	Functional outcome of the paretic limb	48 hours post onset, 7, 14, 21 and 28 days post onset, 3 and 6 months post onset and 1 year post onset
Semmes Weinstein Change	Monofilament sensory test	48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
Timed up and go Change	walking test	48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
10 meter walk test Change	Walking speed test	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 Measures

Outcome Measure	Measure Description	Time Frame
Tardieu spasticity scale Change	spasticity scale, the higher the score the higher the spasticity	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	Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is	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	Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is	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	Upper and lower limb motor outcomes, the higher the score the higher the better the patient is	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	Balance test, the higher the score the higher the worse the patient is	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	Balance test, the higher the score the higher the score, the better the patient is	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	Balance test, the higher the score the higher the better the patient is	48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
Trunk impairment scale Change	balance test, the higher the score the higher the better the patient is	48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Stephen Bornheim, Msc, Liege Univeristy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: tDCS; Acute stroke; WMFT; Semmes Weinstein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No