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Trial record 8 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

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

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ClinicalTrials.gov Identifier: NCT03888209
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bornheim Stephen, University of Liege

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.


Condition or disease Intervention/treatment Phase
Stroke, Acute Device: tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, triple blind, sham controlled
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.
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?
Actual Study Start Date : March 31, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

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 Name: 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 Name: Non invasive brain stimulation




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 Outcome Measures :
  1. Tardieu spasticity scale 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 ]
    spasticity scale, the higher the score the higher the spasticity

  2. Stroke impact scale 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 ]
    Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is

  3. HADS 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 ]
    Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is

  4. Fugl Meyer 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 ]
    Upper and lower limb motor outcomes, the higher the score the higher the better the patient is

  5. 4 square step 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 ]
    Balance test, the higher the score the higher the worse the patient is

  6. Berg Balance scale 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 ]
    Balance test, the higher the score the higher the score, the better the patient is

  7. Postural assessement scale 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 ]
    Balance test, the higher the score the higher the better the patient is

  8. Trunk impairment scale 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 ]
    balance test, the higher the score the higher the better the patient is



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888209


Contacts
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Contact: Stephen Bornheim, Msc 003243663577 stephen.bornheim@uliege.be
Contact: Jean-François Kaux, Phd, MD 003243668241 jfkaux@uliege.be

Locations
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Belgium
Liege Univeristy Hospital Recruiting
Liege, Belgium, 4000
Contact: Stephen Bornheim, Msc         
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Stephen Bornheim, Msc Liege Univeristy Hospital

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Responsible Party: Bornheim Stephen, Assistant Professor, University of Liege
ClinicalTrials.gov Identifier: NCT03888209     History of Changes
Other Study ID Numbers: 2016-287
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bornheim Stephen, University of Liege:
tDCS
WMFT
Semmes Weinstein
Acute stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases