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

NCT07024550 | Active Not Recruiting

• 1 other identifier: BTL-699_CTCZ200
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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; Food Craving; Binge Eating/Loss of Control Eating

Keywords

brain reward pathway; fMRI; brain activity; rTMS; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in the brain reward pathway activity

  The treatment-induced changes in the reward pathway activity of the investigated brain regions detected via fMRI during the food-cue reactivity task for the participants in the active group.

  baseline to 1 month post-treatment

Secondary Outcomes (3)

• Assessment of changes in the FCQ-T (Food cravings questionnaire-trait) score for the active group vs. sham group at 1 month

  baseline and 1 month post-treatment

• Subject satisfaction as assessed by Subject Satisfaction Questionnaire

  baseline to 1 month post-treatment

• Comfort as assessed by Therapy Comfort Questionnaire

  from the first to the last treatment session, assessed up to 42 days

Other Outcomes (1)

• Incidence of Treatment-related Adverse Events

  baseline to 1 month post-treatment

Study Arms (2)

Treatment with BTL-699-2 device

EXPERIMENTAL

During six treatments, the subjects will be exposed to the electromagnetic field delivered non-invasively by the BTL-699-AP M-2 applicator placed on the left dlPFC.

Device: Treatment with BTL-699-2 device

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

SHAM COMPARATOR

During six treatments, the subjects will be exposed to the electromagnetic field delivered non-invasively by the BTL-699-AP M-2 applicator placed on the left dlPFC, with the intensity of the energy set below the therapeutic threshold.

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

Interventions

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

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.

Also known as: Treatment with EXOMIND (BTL-699-2) device with intensity below therapeutic threshold

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

Treatment with BTL-699-2 device 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.

Also known as: Treatment with EXOMIND (BTL-699-2) device

Treatment with BTL-699-2 device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulator.)
• metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see the Safety Precautions and Warnings) or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery, and hair barrettes).
• application in the heart area
• persons with a tendency to seizure (hypotonic, epileptic)
• ongoing anticoagulation therapy
• ongoing severe or life-threatening condition
• ongoing renal dialysis therapy or decompensated renal insufficiency
• decompensated hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
• malignant or benign tumour (within 30 cm of the treatment coil)
• fever
• application over or in the near proximity (within 30 cm of the treatment coil) of tattoos with metallic ink
• Shrapnel or other metal or electronic implants (pacemakers, surgical devices, metallic tattoos on the head, etc.)
• pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
• history of head trauma, increased intracranial pressure or fainting
• major medical, neurological, or psychological disorders (e.g. depression, panic attacks, ADHD, tumors, heart conditions, claustrophobia)

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

National Institute of Mental Health in Czechia

Klecany, 25067, Czechia

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: July 22, 2025
• Primary Completion: November 4, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-10

Locations

CZ (1)