Self-ControlNCT07056036
EXOMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings
A study testing ActiveTreatment with BTL-699-2 in people with Self-Control and Food Cravings, run by BTL Industries Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-Control, Food Cravings
- What is being tested?
- ActiveTreatment with BTL-699-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Diagnosis of major depression, depression, post-traumatic stress disorder, psychotic disorder or current psychotic symptoms, bipolar disorder, obsessive-compulsive disorder, borderline personality disorder
- Personal history of syncope (except the reflex syncope)
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
- Withdrawal from one of the following drugs could form a relative hazard for the application of rTMS due to the resulting significant seizure threshold lowering potential: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrate etc.)
- Systemic infection
- Patients with a broad range of neuropsychiatric diseases are at elevated risk for seizures. Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative 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 medications due to reduced clearance
- Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
- The use of methamphetamine, barbiturates, cocaine metabolites, opiates and phencyclidine 72 hours before the therapy
- Contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jiva Med Spa
Columbus, Ohio, 43215
Aria Integrative Health
Denver, Colorado, 80211
A New You Wellness
Miami, Florida, 33156
Cady Wellness Institute
Newburgh, Indiana, 47630
About this study
Official title: Safety and Efficacy of BTL-699-2 for the Improvement in Willpower, Self-control & Food Cravings
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
Read the detailed 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.
- Conditions
- Self-Control, Food Cravings
- Being tested
- ActiveTreatment with BTL-699-2, Sham Treatment with BTL-699-2
- Keywords
- self-control, willpower, food cravings, rTMS, ExoTMS, EXOMIND
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveTreatment with BTL-699-2Device
Also called EXOMIND (BTL-699-2) ActiveTreatment
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.
Sham Treatment with BTL-699-2Device
Also called EXOMIND (BTL-699-2) ShamTreatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Treatment with BTL-699-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (5)
Assessment of Change in Food Cravings
The change in the score obtained from the Food Cravings Questionnaire - Trait (FCQ-T) 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 39 to 234 and higher scores indicate more frequent and intense experiences of food craving in general. An improvement is defined as a decrease in score.
Measured: 15 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction Questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicate better outcomes.
Measured: 15 months
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicate higher therapy comfort.
Measured: 15 months
Assessment of Pain During Therapy
The Therapy Comfort Questionnaire will be used to evaluate pain experienced during treatment sessions. It will be administered after the final treatment. The questionnaire includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
Measured: 15 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the treatment with the BTL-699-2 device for the improvement of well-being and to identify side effects and adverse events associated with the study treatment.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Nov 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056036
- Sponsor's protocol ID
- BTL-699_CTUS200
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of BTL-699-2 for the Improvement in Willpower, Self-control & Food Cravings
- ClinicalTrials.gov ID
- NCT07056036
- Acronym / sponsor ID
- BTL-699_CTUS200
- Conditions
- Self-Control, Food Cravings
- Keywords
- self-control, willpower, food cravings, rTMS, ExoTMS, EXOMIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment with BTL-699-2 | Experimental | Device: ActiveTreatment with BTL-699-2Participants will receive BTL-699-2 treatments with an intensity of up to 70% of their motor threshold. |
| Sham treatment with BTL-699-2 | Sham comparator | Device: Sham Treatment with BTL-699-2Participants will receive BTL-699-2 treatments with an intensity of 5% of their motor threshold. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveTreatment with BTL-699-2Also: EXOMIND (BTL-699-2) ActiveTreatmentParticipants 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. | Device | Active treatment with BTL-699-2 |
| Sham Treatment with BTL-699-2Also: EXOMIND (BTL-699-2) ShamTreatmentParticipants 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. | Device | Sham treatment with BTL-699-2 |
Primary outcome
Assessment of Change in Willpower and Self-control
Time frame: 15 months
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.
5 secondary outcomes
Assessment of Change in Food Cravings
Time frame: 15 months
Assessment of Satisfaction
Time frame: 15 months
Assessment of Therapy Comfort
Time frame: 15 months
Assessment of Pain During Therapy
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveTreatment with BTL-699-2 in people with Self-Control and Food Cravings, run by BTL Industries Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Change in Willpower and Self-control (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.