NCT04343612

Brief Summary

20 healthy subjects will be split into 4 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal or placebo Subjects will receive 2mA for 20 mins of their attributed tDCS. The evaluation is a maximal strength test measured with the IOPI and will take place prior to, immediately following and 30 minutes after stimulation

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
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable healthy

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 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

April 9, 2020

Last Update Submit

May 18, 2020

Conditions

Keywords

tDCSIOPITongue StrengthHealthy

Outcome Measures

Primary Outcomes (1)

  • Change Tongue Maximal Strength

    1 RM of tongue strength, measured using the IOPI device

    Baseline, immediately after, and 30 minutes after tDCS

Study Arms (4)

Anodal

EXPERIMENTAL

Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation

Device: Transcranial Direct Current Stimulation

Bilateral

EXPERIMENTAL

Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation

Device: Transcranial Direct Current Stimulation

Cathodal

EXPERIMENTAL

Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation

Device: Transcranial Direct Current Stimulation

Placebo

PLACEBO COMPARATOR

anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation

Device: Transcranial Direct Current Stimulation

Interventions

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

Also known as: tDCS
AnodalBilateralCathodalPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

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

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

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Stephen Bornheim, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Everyone is blinded, codes are selected by a third party not involved in any step of the study
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 4 groups, each group receives one of three treatments or the sham treatment. Double-blinded, sham controlled, crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

May 7, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations