CompletedNot Applicable

EXOMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings

United States51 participantsStarted 2024-11-01

Plain-language summary

The goal of this clinical trial is to evaluate if the treatment with ExoMIND (BTL-699-2) device is able to improve willpower, self-control and food cravings in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with EXOMIND (BTL-699-2) device improve willpower, self-control and food cravings? Participants will be asked to: * Undergo six treatments * Complete the Brief Self-control Scale * Complete the Food Cravings Questionnaire - Trait * Complete the Therapy Comfort Questionnaire * Complete the Subject Satisfaction Questionnaire

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 22 years * Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb * Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement of willpower and self-control and rI eduction of food cravings, including non-invasive brain stimulation treatments other than the study procedure during study participation * Subjects willing and able to maintain their regular (pre-procedure) exercise regimen without affecting significant change in either direction during study participation * Willingness to comply with study instructions and to return to the clinic for the required visits * Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study * If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry Exclusion Criteria: * Electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, ocular implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious inj…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Change in Willpower and Self-control

Timeframe: 15 months

Trial details

NCT IDNCT07056036

SponsorBTL Industries Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Self-Control trials