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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sham treatment with BTL-699-2 | Sham Comparator | Participants will receive BTL-699-2 treatments with an intensity of 5% of their motor threshold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aria Integrative Health | Denver | Colorado | 80211 | United States | ||
| A New You Wellness |
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| ID | Term |
|---|---|
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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|
| 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. |
|
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| 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. | 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. | 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. | 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. | 15 months |
| Miami |
| Florida |
| 33156 |
| United States |
| Cady Wellness Institute | Newburgh | Indiana | 47630 | United States |
| Jiva Med Spa | Columbus | Ohio | 43215 | United States |