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

NCT07024550 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Binge Eating Behaviour
  • Binge Eating/Loss of Control Eating
  • Food Craving

Interventions

DEVICE

Treatment with BTL-699-2 device

The treatment schedule with BTL-699-2 device will consist of six 24.5-minute treatments spaced 3-7 days apart. The therapy parameters will be adjusted according to patient feedback, but should never exceed 70% of the individual's MT in the active group.

DEVICE

Treatment with BTL-699-2 device with intensity below therapeutic threshold

The treatment schedule with BTL-699-2 device will consist of six 24.5-minute treatments spaced 3-7 days apart. The intensity of the energy will be set below the therapeutic threshold.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2025-11-04
Completion
2026-09-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024550 on ClinicalTrials.gov