ExoMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings

Last updated: July 10, 2025
Sponsor: BTL Industries Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ActiveTreatment with BTL-699-2

Sham Treatment with BTL-699-2

Clinical Study ID

NCT07056036
BTL-699_CTUS200
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 in adults above the age of 22 years. The main question it aims to answer is:

Does the treatment with ExoMIND (BTL-699-2) device improve willpower, self-control and food cravings?

Participants will be asked to:

  • Undergo six treatments

  • Complete the Brief Self-control Scale

  • Complete the Food Cravings Questionnaire - Trait

  • Complete the Therapy Comfort Questionnaire

  • Complete the Subject Satisfaction Questionnaire

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 22 years

  • 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 treatments other than thestudy procedure for the improvement of willpower and self-control and rI eduction offood cravings, including non-invasive brain stimulation treatments other than thestudy procedure during study participation

  • Subjects willing and able to maintain their regular (pre-procedure) exercise regimenwithout affecting significant change in either direction 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

  • If applicable, subjects will be maintained on pre-study prescribed medications at astable therapeutic dosage for at least 2 months prior to study entry

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

  • Drug pump(s)

  • Application in the heart area

  • Persons with a tendency to seizure (hypotonic, epileptic), or a personal history ofepilepsy

  • 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 tumor

  • Fever

  • Ongoing pregnancy or nursing

  • Ongoing intake disorders such as bulimia or anorexia

  • Diagnosis of major depression, depression, post-traumatic stress disorder, psychoticdisorder or current psychotic symptoms, bipolar disorder, obsessive-compulsivedisorder, borderline personality disorder

  • 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)

  • 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

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

  • The use of methamphetamine, 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: 60
Treatment Group(s): 2
Primary Treatment: ActiveTreatment with BTL-699-2
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study uses a prospective, multi-center, two-arm, sham-controlled, single-blinded interventional study design.

The subjects will be enrolled and assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with the BTL-699-2 device. Group A will receive rTMS treatment with an intensity of up to 70% of their MT, while Group B will receive rTMS treatment with an intensity of 5% of their MT. Six (6) treatments will be delivered, 3-7 days apart. Examination for possible adverse effects will be conducted after each treatment.

The Brief Self-Control Scale and the Food Cravings Questionnaire - Trait (FCQ-T) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.

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

The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.

Connect with a study center

  • Aria Integrative Health

    Denver, Colorado 80211
    United States

    Active - Recruiting

  • A New You Wellness

    Miami, Florida 33156
    United States

    Active - Recruiting

  • Cady Wellness Institute

    Newburgh, Indiana 47630
    United States

    Active - Recruiting

  • Jiva Med Spa

    Columbus, Ohio 43215
    United States

    Active - Recruiting

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