ExoMIND for Food Cravings

No longer recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Anticoagulants, Immunosuppressives, Methamphetamine, others

Disqualifiers: Epilepsy, Heart disorders, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 3-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called ExoMIND (BTL-699-2) to determine its effectiveness in helping people control food cravings and improve willpower and self-control. Participants will undergo six treatment sessions and complete questionnaires about their experiences. The trial includes two groups: one receiving the actual treatment and another receiving a low-intensity version for comparison. Individuals over 22 who struggle with food cravings and can maintain their usual exercise routine may find this trial suitable. However, those with electronic implants or certain medical conditions, such as epilepsy or heart disorders, cannot participate. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could lead to new solutions for managing food cravings.

Do I have to stop taking my current medications for the trial?

The trial requires that you stay on your current prescribed medications at a stable dose for at least 2 months before joining. So, you won't need to stop taking them.

What prior data suggests that the ExoMIND (BTL-699-2) device is safe for improving willpower and self-control?

Research shows that the ExoMIND (BTL-699-2) device is generally easy for participants to use. In earlier studies, most people experienced positive effects, such as fewer food cravings and better control over their eating. Importantly, no major negative side effects have been reported with this treatment. This suggests that the device is safe for people, based on current information. Prospective trial participants may find this information reassuring regarding the safety of the ExoMIND device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for food cravings focus on willpower or diet changes, but ExoMIND (BTL-699-2) stands out because it's a non-invasive brain stimulation technique. Unlike traditional medications or behavioral therapies, ExoMIND uses targeted electromagnetic pulses to potentially reduce cravings by modulating brain activity. Researchers are excited about this innovative approach as it directly targets the brain regions associated with cravings, offering a new way to tackle overeating without the side effects of medications.

What evidence suggests that the ExoMIND device is effective for improving willpower, self-control, and food cravings?

Research has shown that ExoMIND (BTL-699-2), which participants in this trial may receive, may help reduce food cravings. In one study, 89.5% of participants felt less urge to snack during the day after using the treatment, and 94.7% were happy with the results. The device stimulates the brain, potentially boosting willpower and self-control by affecting brain reward systems. These positive findings suggest the treatment could effectively help manage food cravings. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 22 years old who want to improve their willpower, self-control, and manage food cravings. Participants must be willing to undergo six treatments with the ExoMIND (BTL-699-2) device and complete several questionnaires about self-control and satisfaction with therapy.

Inclusion Criteria

I am older than 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

Willingness to comply with study instructions and to return to the clinic for the required visits

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 injury or death

Metallic, conductive, ferromagnetic or other magnetic sensitive implants/objects in the head or within 30 cm of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes) with some exceptions in the mouth as standard amalgam dental fillings, single post dental implants, and dental bridge work. Failure to follow this restriction could result in serious injury or death

Drug pump(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six treatments with the BTL-699-2 device, 3-7 days apart, with monitoring for adverse effects after each session

3-6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month and 3 months post-treatment

3 months

2 visits (in-person)

Long-term monitoring

Monitoring of adverse reactions and side effects continues for the evaluation of safety and identification of side effects and adverse events

15 months

What Are the Treatments Tested in This Trial?

Interventions

• ExoMIND (BTL-699-2)

Trial Overview

The study tests if the ExoMIND (BTL-699-2) device can boost willpower and reduce food cravings. It involves an active treatment group using BTL-699-2 and a sham treatment group for comparison. The effectiveness is measured through questionnaires before and after treatments.

How Is the Trial Designed?

Group I: Active treatment with BTL-699-2 Experimental Treatment 1 Intervention

Participants will receive BTL-699-2 treatments with an intensity of up to 70% of their motor threshold.

Group II: Sham treatment with BTL-699-2 Placebo Group 1 Intervention

Participants will receive BTL-699-2 treatments with an intensity of 5% of their motor threshold.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07056036

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

The score ranges from 39 to 234 and higher scores indicate more frequent and intense experiences of food craving in general. An improvement is defined as a ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12447532/

ExoTMS transcranial magnetic stimulation for the reduction ...

One month posttreatment, 94.7% of subjects were satisfied with the results, 89.5% had diminished food cravings and urge to snack during the day, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07024550

Impact of the EXOMIND (BTL-699-2) on the Brain Reward ...

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 ...

4.

withpower.com

withpower.com/trial/phase-self-control-10-2024-f0b49

ExoMIND for Food Cravings · Info for Participants

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 ...

5.

clinicaltrial.be

clinicaltrial.be/en/details/556831?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

The Effectiveness of rTMS on Improving Food Craving and ...

Risks of Participation. Participants may experience mild discomfort from brain stimulation treatment. A small percentage of users may ...

6.

app.trialscreen.org

app.trialscreen.org/trials/btl-699-reduction-food-cravings-trial-nct06889298

EXOMIND (BTL-699) for the Reduction of Food Cravings

The goal of this clinical trial is to evaluate if the treatment with BTL-699 device is able to temporarily reduce food cravings in adults ...