Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway (NCT07024550) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway
Czechia8 participantsStarted 2025-07-22
Plain-language summary
The goal of this clinical trial is to thoroughly explore and ascertain the mechanism of action of the therapy with the EXOMIND (BTL-699-2) device in the treatment of food cravings (serving as an important precipitant to binge eating episodes), among binge eaters and to confirm its efficacy and safety, in adult binge-eating patients with food cravings. The main question it aims to answer is:
To ascertain the mechanism of action of the treatment with the EXOMIND (BTL-699-2) device equipped with a BTL-699-AP-M-2 applicator in reducing food cravings, for the active group only.
Participants will complete six treatments and one follow-up visit.
Who can participate
Age range
19 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 \> 19 years
* Any self-reported excessive overeating episodes in the last 2 months
* The minimal pre-treatment FCQ-T score of 100 points
* 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 at least five out of ten times
* Subjects willing and able to abstain from partaking in any other weight management procedures (including diet and exercise regime changes) other than the study procedure during the study participation
* Subjects willing and able to abstain from initiating any other eating disorder treatments other than the study procedure during the study participation
* Subjects willing and able to undergo fMRI scanning, structural MRI scanning, and EEG recording, and proceed with the instructions from the study staff during the measurement
* 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 maintain pre-study prescribed medications at a stable therapeutic dosage and/or with maintained frequency of psychotherapy during the study participation. The pre-study treatment regime needs to be set and maintained for at least 2 months prior to the study enrollment
Exclusion Criteria:
* Electronic implants (Implanted stimulat…
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
1
Assessment of changes in the brain reward pathway activity