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The goal of this clinical trial is to evaluate if the treatment with the BTL-995-rTMS device is able to reduce binge eating in adults above the age of 22 years. The main question it aims to answer is:
Whether the treatment with the BTL-995-rTMS device reduces binge eating.
Participants will be asked to:
Undergo six treatments Undergo weight measurements Complete the Binge Eating Scale Complete the Therapy Comfort Questionnaire Complete the Satisfaction Questionnaire
This study uses a single-center, single-arm, open-label, interventional design.
Subjects scoring more than 17 points on the Binge Eating Scale will be enrolled and assigned into one experimental study arm. All participants will receive six treatments with the BTL-995-rTMS device, administered 2 to 4 days apart.
Therapy parameters will be adjusted based on patient feedback and comfort, up to 70% of the individual's motor threshold.
Examination for possible adverse effects will be assessed at each visit.
The Binge Eating Scale will be administered before the first treatment, after the last treatment, and at the 1-month follow-up visit after the final session.
The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at the follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with BTL-995-rTMS | Experimental | Transcranial magnetic stimulation treatment with the BTL-995-rTMS device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BTL-995-rTMS | Device | Six transcranial magnetic stimulation treatments with the BTL-995-rTMS device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 4 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Change in Binge Eating | The change in the score obtained from the Binge Eating Scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the1-month follow-up visit. The score ranges from 0 to 46 and higher scores indicate more frequent and severe binge eating. An improvement is defined as a decrease in score. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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") and the 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Analog Scale for pain indicate higher therapy comfort. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center "Intermedica" | Sofia | 1680 | Bulgaria |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D052018 | Bulimia Nervosa |
| D006963 | Hyperphagia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 3 months |
| Assessment of Satisfaction | Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Satisfaction questionnaire. The questionnaire will be administered after the last treatment, and at the 1-month follow-up visits. Responses to questions about binge eating and satisfaction with the treatment outcomes will range from "strongly agree" (5 points) to "strongly disagree" (1 point). A higher score for each statement indicate better outcomes. | 3 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-995-rTMS device for the reduction of binge eating and to identify side effects and adverse events associated with the study treatment. | 3 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |