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

Last updated: September 15, 2025
Sponsor: BTL Industries Ltd.
Overall Status: Completed

Phase

N/A

Condition

Vomiting

Bulimia

Weight Loss

Treatment

Treatment with BTL-995-rTMS

Clinical Study ID

NCT06910592
BTL-995_CTBG100
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 motorthreshold could be established as the minimum stimulus required to inducecontraction of the right thumb

  • Subjects willing and able to abstain from partaking in any other weight managementtreatments other than the study procedure during study participation

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

  • Women of child-bearing potential* are required to use birth control measures duringthe whole duration of the study

Exclusion

Exclusion Criteria:

  • Electronic implants (Implanted stimulator devices in or near the head - rTMS devicesare 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 injuryor death.

  • Metallic or other magnetic sensitive implants/objects in or near the head - rTMSdevices are contraindicated for use in patients who have conductive, ferromagneticor other magnetic-sensitive metals implanted in their head or within 30 cm of thetreatment coil. (Examples include implanted electrodes/stimulators, aneurysm clipsor coils, stents, bullet fragments, jewellery and hair barrettes. Failure to followthis 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, cardiovasculardiseases

  • 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 personalitydisorder, major depression (elevated seizure risk) or bipolar disorder Personalhistory of epilepsy

  • Personal history of syncope (except the reflex syncope)

  • Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, evenwithout a history of seizure, and without anticonvulsant medication

  • Withdrawal from one of the following drugs could form a relative hazard for theapplication of rTMS due to the resulting significant seizure threshold loweringpotential: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrateetc.)

  • Systemic infection

  • Patients with a broad range of neuropsychiatric diseases are at elevated risk forseizures. Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and otherneurodegenerative diseases, meningoencephalitis or intracerebral abscess,parenchymal or leptomeningeal cancers) are associated with an elevated risk forseizures

  • History of hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia,renal failure/uremia, liver failure

  • History of tendency for raised blood concentrations of pro-convulsant medicationsdue to reduced clearance (e.g. secondary to initiation of antibiotics for treatmentof infections)

  • Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that cancause the posterior reversible leukoencephalopathy syndrome

  • The use of amphetamines, barbiturates, cocaine metabolites, opiates andphencyclidine 72 hours before the therapy.

  • Contradictions for the testing used in the trial, for example, the motor thresholdcannot be found or quantified.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Treatment with BTL-995-rTMS
Phase:
Study Start date:
July 26, 2023
Estimated Completion Date:
March 11, 2024

Study Description

This study uses a single-center, single-arm, open-label, interventional design.

Subjects scoring more than 17 points on the Binge Eating Scale will be enrolled and assigned into one experimental study arm. All participants will receive six treatments with the BTL-995-rTMS device, administered 2 to 4 days apart.

Therapy parameters will be adjusted based on patient feedback and comfort, up to 70% of the individual's motor threshold.

Examination for possible adverse effects will be assessed at each visit.

The Binge Eating Scale will be administered before the first treatment, after the last treatment, and at the 1-month follow-up visit after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at the follow-up visit.

Connect with a study center

  • Medical Center "Intermedica"

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Medical Center "Intermedica"

    Sofia 727011, 1680
    Bulgaria

    Site Not Available

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