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

NCT ID: NCT03888209

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, triple blind, sham controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Anodal tDCS

Patients will receive 20min anodal tDCS

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

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

Sham tDCS

Patients will receive 20 minutes of Sham anodal tDCS

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

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

Interventions

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tDCS

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

Intervention Type DEVICE

Other Intervention Names

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Non invasive brain stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Bornheim Stephen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Bornheim, Msc

Role: PRINCIPAL_INVESTIGATOR

Liege Univeristy Hospital

Locations

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Liege Univeristy Hospital

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Stephen Bornheim, Msc

Role: CONTACT

003243663577

Jean-François Kaux, Phd, MD

Role: CONTACT

003243668241

Facility Contacts

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Stephen Bornheim, Msc

Role: primary

Other Identifiers

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2016-287

Identifier Type: -

Identifier Source: org_study_id

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