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

Stroke, Acute Clinical Trial

— 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 ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888209
• Other study ID #: 2016-287
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2019
• Source: University Hospital of Liege
• Contact: Stephen Bornheim, Msc
• Phone: 003243663577
• Email: stephen.bornheim[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• tDCS
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham

Locations

Country	Name	City	State
Belgium	Liege Univeristy Hospital	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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