HealthyNCT04343612
Different Montages of Transcranial Direct Current Stimulation Tongue Strength
A study testing Transcranial Direct Current Stimulation in people with Healthy, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Liege Univeristy
Liège, 4000
Stephen Bornheim, Msc
About this study
Official title: The Effects of Different Montages of Transcranial Direct Current Stimulation on Tongue Strength in Healthy Subjects
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
- Conditions
- Healthy
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, IOPI, Tongue Strength, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
| Study group | Role | What they receive |
|---|---|---|
| Anodal | Experimental | Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation Receives: Device: Transcranial Direct Current Stimulation |
| Bilateral | Experimental | Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation Receives: 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 Receives: 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 Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Tongue Maximal Strength
1 RM of tongue strength, measured using the IOPI device
Measured: Baseline, immediately after, and 30 minutes after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start7 May 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4 groups, each group receives one of three treatments or the sham treatment. Double-blinded, sham controlled, crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bornheim Stephen, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343612
- Sponsor's protocol ID
- 2020-93
- Status last verified
- May 2020
- First submitted
- 9 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30431445
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Montages of Transcranial Direct Current Stimulation on Tongue Strength in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04343612
- Acronym / sponsor ID
- 2020-93
- Conditions
- Healthy
- Keywords
- tDCS, IOPI, Tongue Strength, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 groups, each group receives one of three treatments or the sham treatment. Double-blinded, sham controlled, crossover study
| Arm | Type | Receives |
|---|---|---|
| Anodal | Experimental | Device: Transcranial Direct Current StimulationAnode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation |
| Bilateral | Experimental | Device: Transcranial Direct Current StimulationAnode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation |
| Cathodal | Experimental | Device: Transcranial Direct Current StimulationCathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation |
| Placebo | Placebo comparator | Device: Transcranial Direct Current Stimulationanode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSSubjects received a micro-current through their scalp to induce cortical and subcortical changes | Device | Anodal, Bilateral, Cathodal, Placebo |
Primary outcome
Change Tongue Maximal Strength
Time frame: Baseline, immediately after, and 30 minutes after tDCS
1 RM of tongue strength, measured using the IOPI device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Background: PubMed 30431445Bornheim 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.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Healthy, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Bornheim, Msc (003243662193, stephen.bornheim@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Tongue Maximal Strength (time frame: Baseline, immediately after, and 30 minutes after tDCS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.