An interventional study of ActiveTreatment with BTL-699-2 and Sham Treatment with BTL-699-2 in Self-Control and Food Cravings, sponsored by BTL Industries Ltd.. Completed at 4 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
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.
168 studies on the registry are indexed under Self-Control; 22 are open to participants now.
This study's enrollment of 51 is below the median of 88 across 144 interventional studies indexed under Self-Control.
Browse Self-Control studies →BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive BTL-699-2 treatments with an intensity of up to 70% of their motor threshold.
Device: ActiveTreatment with BTL-699-2
Participants will receive BTL-699-2 treatments with an intensity of 5% of their motor threshold.
Device: Sham Treatment with BTL-699-2
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
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
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.
Time frame: 15 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15 months
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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