EXOMIND (BTL-995) for Reduction of Binge-eating

NCT06910592 | Completed

• 1 other identifier: BTL-995_CTBG100
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate if the treatment with the BTL-995-rTMS device is able to reduce binge eating in adults above the age of 22 years. The main question it aims to answer is: Whether the treatment with the BTL-995-rTMS device reduces binge eating. Participants will be asked to: Undergo six treatments Undergo weight measurements Complete the Binge Eating Scale Complete the Therapy Comfort Questionnaire Complete the Satisfaction Questionnaire

Conditions

Binge-Eating Disorder

Keywords

binge-eating; overeating; weight loss; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Binge Eating

  The change in the score obtained from the Binge Eating Scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the1-month follow-up visit. The score ranges from 0 to 46 and higher scores indicate more frequent and severe binge eating. An improvement is defined as a decrease in score.

  3 months

Secondary Outcomes (3)

• Assessment of Therapy Comfort

  3 months

• Assessment of Satisfaction

  3 months

• Incidence of Treatment-related Adverse Events

  3 months

Study Arms (1)

Treatment with BTL-995-rTMS

EXPERIMENTAL

Transcranial magnetic stimulation treatment with the BTL-995-rTMS device

Device: Treatment with BTL-995-rTMS

Interventions

Treatment with BTL-995-rTMS DEVICE

Six transcranial magnetic stimulation treatments with the BTL-995-rTMS device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 4 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold.

Also known as: EXOMIND (BTL-995) with ExoTMS

Treatment with BTL-995-rTMS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scoring more than 17 points based on the BES
• Age \> 22 years
• Voluntarily signed informed consent
• 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 other weight management treatments other than the study procedure 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

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 implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious injury or death.
• Metallic 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 or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery and hair barrettes. Failure to follow this restriction could result in serious injury or death.)
• Drug pump(s)
• Persons with a tendency to seizure (hypotonic, epileptic)
• Ongoing anticoagulation therapy
• Ongoing severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
• Malignant or benign tumour
• Fever
• Facial tattoos with metallic ink (within 30 cm of the treatment coil)
• Pregnancy or nursing
• Ongoing intake disorders such as bulimia or anorexia, borderline personality disorder, major depression (elevated seizure risk) or bipolar disorder Personal history of epilepsy

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Medical Center "Intermedica"

Sofia, 1680, Bulgaria

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia Nervosa; Hyperphagia; Weight Loss

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: July 26, 2023
• Primary Completion: December 15, 2023
• Study Completion: March 11, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)