HealthytDCSNCT04994379
Investigating the Effects of Intensity of Transcranial Direct Current Stimulation on Subjective Appetite
A study testing 1 mA tDCS and 1.5 mA tDCS in people with Healthy, run by University of Messina at 1 site in Italy.
Trial summary
This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1 mA tDCS and 1.5 mA tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 1 Feb 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight, based on the Body Mass Index (BMI)
- Males and females between 18 and 35
Who cannot join
- Use of psychoactive drugs
- Presence of metal implants in the brain, skull, scalp or neck
- Use of pacemaker
- Neurological or psychiatric pathologies
- History of severe head injury
- Pregnancy
- Clinical obesity based on BMI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal TDCS on Appetite; a Double-blind Sham-controlled Study
This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.
Read the detailed description
After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.
- Conditions
- Healthy
- Being tested
- 1 mA tDCS, 1.5 mA tDCS, Sham tDCS
- Keywords
- Perceived appetite, tDCS, Submental muscle, M1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mA tDCSDevice
One session with stimulation intensity of 1 mA.
1.5 mA tDCSDevice
One session with stimulation intensity of 1.5 mA.
Sham tDCSDevice
One session of sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 1 mA tDCS | Experimental | Participants receive the stimulation with an intensity of 1 mA. Receives: Device: 1 mA tDCS |
| 1.5 mA tDCS | Experimental | Participants receive the stimulation with an intensity of 1.5 mA. Receives: Device: 1.5 mA tDCS |
| Sham tDCS | Sham comparator | Participants receive the sham stimulation (zero electric current after a short initial increase). Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the subjective rating of appetite
A visual analogue scale (VAS; from 0 meaning not hungry at all, to 100 meaning extremely hungry), will be used to record the perceived level of hunger before and after the stimulation to enable evaluation of the effects of stimulation on perceived appetite.
Measured: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
Secondary outcomes (1)
Change in excitability of the submental muscle region in primary motor cortex
Recording motor evoked potentials from the area of the submental region of the motor cortex in addition to a control site (APB muscle), to allow for comparisons of the amplitude of MEPs before and after stimulation to draw conclusions about the effect of stimulation and its contribution to the potential behavioral modulations of tDCS
Measured: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Aug 2021
- Primary completion1 Sep 2021
- Study completion1 Feb 2022
Why it stopped: Working conditions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abed Hadipour Lakmehsari, University of Messina
- Investigators
- Carmelo Mario Vicario, PhD, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994379
- Sponsor's protocol ID
- Tongue Motor Cortex
- Acronym
- tDCS
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal TDCS on Appetite; a Double-blind Sham-controlled Study
- ClinicalTrials.gov ID
- NCT04994379
- Acronym / sponsor ID
- tDCS / Tongue Motor Cortex
- Conditions
- Healthy
- Keywords
- Perceived appetite, tDCS, Submental muscle, M1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Working conditions.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Aug 2021 (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.
This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.
Detailed description
After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
| Arm | Type | Receives |
|---|---|---|
| 1 mA tDCS | Experimental | Device: 1 mA tDCSParticipants receive the stimulation with an intensity of 1 mA. |
| 1.5 mA tDCS | Experimental | Device: 1.5 mA tDCSParticipants receive the stimulation with an intensity of 1.5 mA. |
| Sham tDCS | Sham comparator | Device: Sham tDCSParticipants receive the sham stimulation (zero electric current after a short initial increase). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal weight, based on the Body Mass Index (BMI)
- Males and females between 18 and 35
Key exclusion criteria (7 listed)
- Use of psychoactive drugs
- Presence of metal implants in the brain, skull, scalp or neck
- Use of pacemaker
- Neurological or psychiatric pathologies
- History of severe head injury
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 |
|---|---|---|
| 1 mA tDCSOne session with stimulation intensity of 1 mA. | Device | 1 mA tDCS |
| 1.5 mA tDCSOne session with stimulation intensity of 1.5 mA. | Device | 1.5 mA tDCS |
| Sham tDCSOne session of sham stimulation. | Device | Sham tDCS |
Primary outcome
Change in the subjective rating of appetite
Time frame: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
A visual analogue scale (VAS; from 0 meaning not hungry at all, to 100 meaning extremely hungry), will be used to record the perceived level of hunger before and after the stimulation to enable evaluation of the effects of stimulation on perceived appetite.
1 secondary outcome
Change in excitability of the submental muscle region in primary motor cortex
Time frame: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
Results and safety
The study was stopped early (reason given: Working conditions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Carmelo Mario Vicario, PhD study director
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 mA tDCS and 1.5 mA tDCS in people with Healthy, run by University of Messina at 1 site in Italy.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Dec 2024. 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 Italy. 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?
The study was stopped early (reason given: Working conditions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the subjective rating of appetite (time frame: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.