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

NCT07056036 | Completed FDA Device

• 1 other identifier: BTL-699_CTUS200
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Self-Control; Food Cravings

Keywords

self-control; willpower; food cravings; rTMS; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Willpower and Self-control

  The change in the score obtained from the Brief Self-Control scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, at the 1-month and 3-month follow-up visits. The score ranges from 13 to 65 and higher scores indicate a higher level of self-control. An improvement is defined as an increase in score.

  15 months

Secondary Outcomes (5)

• Assessment of Change in Food Cravings

  15 months

• Assessment of Satisfaction

  15 months

• Assessment of Therapy Comfort

  15 months

• Assessment of Pain During Therapy

  15 months

• Incidence of Treatment-related Adverse Events

  15 months

Study Arms (2)

Active treatment with BTL-699-2

EXPERIMENTAL

Participants will receive BTL-699-2 treatments with an intensity of up to 70% of their motor threshold.

Device: ActiveTreatment with BTL-699-2

Sham treatment with BTL-699-2

SHAM COMPARATOR

Participants will receive BTL-699-2 treatments with an intensity of 5% of their motor threshold.

Device: Sham Treatment with BTL-699-2

Interventions

ActiveTreatment with BTL-699-2 DEVICE

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

Also known as: EXOMIND (BTL-699-2) ActiveTreatment

Active treatment with BTL-699-2

Sham Treatment with BTL-699-2 DEVICE

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will se to 5% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

Also known as: EXOMIND (BTL-699-2) ShamTreatment

Sham treatment with BTL-699-2

Eligibility Criteria

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

You may qualify if:

• Age \> 22 years
• 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 treatments other than the study procedure for the improvement of willpower and self-control and rI eduction of food cravings, including non-invasive brain stimulation treatments other than the study procedure during study participation
• Subjects willing and able to maintain their regular (pre-procedure) exercise regimen without affecting significant change in either direction 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
• If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry

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, conductive, ferromagnetic or other magnetic sensitive implants/objects in the head or within 30 cm of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes) with some exceptions in the mouth as standard amalgam dental fillings, single post dental implants, and dental bridge work. Failure to follow this 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 of epilepsy
• 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 tumor
• Fever
• Ongoing pregnancy or nursing
• Ongoing intake disorders such as bulimia or anorexia

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (4)

Aria Integrative Health

Denver, Colorado, 80211, United States

Location

A New You Wellness

Miami, Florida, 33156, United States

Location

Cady Wellness Institute

Newburgh, Indiana, 47630, United States

Location

Jiva Med Spa

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

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 10, 2025
• First Posted: July 9, 2025
• Study Start: November 1, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-06

Locations

US (4)