NCT04349488

Brief Summary

16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham. Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

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

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 13, 2020

Last Update Submit

April 23, 2020

Conditions

Acute Stroke

Keywords

Acute StroketDCSAnodalBalanceWalking

Outcome Measures

Primary Outcomes (6)

  • Changes Four Square Step Test

    The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

  • Changes Berg Balance Scale

    Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

  • Changes Postural Assessment Scale For Stroke

    alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

  • Changes Trunk Impairment Scale

    alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

  • Changes Time Up & Go

    To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

  • Changes 10 meter walking test

    10 meter walking test, the faster the better

    Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Device: Anodal Transcranial Direct Current Stimulation

Placebo

PLACEBO COMPARATOR

Anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Device: Anodal Transcranial Direct Current Stimulation

Interventions

Anodal Transcranial Direct Current StimulationDEVICE

Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Also known as: tDCS
PlaceboTreatment

Eligibility Criteria

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

You may qualify if:

  • First Ever Stroke
  • Motor or sensory deficit
  • Understands and follows orders
  • Signed inform consent

You may not qualify if:

  • One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liege Univeristy Hospital

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

  • Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.

    PMID: 30431445BACKGROUND

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

Central Study Contacts

Stephen Bornheim, Msc

CONTACT

003243662193stephen.bornheim@uliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group receives anodal tDCS, one placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

April 16, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)