NCT03888209

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

March 21, 2019

Last Update Submit

April 2, 2019

Conditions

Stroke, Acute

Keywords

tDCSWMFTSemmes WeinsteinAcute stroke

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Patients will receive 20min anodal tDCS

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Patients will receive 20 minutes of Sham anodal tDCS

Device: tDCS

Interventions

tDCSDEVICE

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

Also known as: Non invasive brain stimulation
Anodal tDCSSham tDCS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman or man
  • Between 18 and 80 years old
  • First ever stroke
  • Capable of signing the consent form

You may not qualify if:

  • One on the TSST (in high and relatively high risk sections)
  • Previous neurological or orthopedic pathologies affecting limbs
  • Cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liege Univeristy Hospital

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Stephen Bornheim, Msc

    Liege Univeristy Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Bornheim, Msc

CONTACT

003243663577stephen.bornheim@uliege.be

Jean-François Kaux, Phd, MD

CONTACT

003243668241jfkaux@uliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, triple blind, sham controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 25, 2019

Study Start

March 31, 2019

Primary Completion

June 30, 2020

Study Completion

August 31, 2020

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)