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Clinical Trials/NCT03888209
NCT03888209UnknownNot Applicable

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

University of Liege2 sites in 1 country50 target enrollmentStarted: March 31, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
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

Experimental

Patients will receive 20min anodal tDCS

Intervention: tDCS (Device)

Sham tDCS

Sham Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bornheim Stephen

Assistant Professor

University of Liege

Study Sites (2)

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