Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate if the treatment with EXOMIND (BTL-699-2) device is able to improve mental well-being 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 mental well-being?
Participants will be asked to:
The study uses a multi-center, single-arm, open-label, interventional study design. The subjects will be enrolled and assigned to one experimental study arm. All enrolled participants will receive four treatment visits, 5-10 days apart.
The Warwick Edinburgh Mental Well-being Scale (WEMWBS) 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 & Mental Wellness 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with BTL-699-2 | Experimental | Transcranial magnetic stimulation treatments with the BTL-699-2 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BTL-699-2 | Device | Four transcranial magnetic stimulation treatments with the BTL-699-2 device will be delivered over the left dorsolateral prefrontal cortex, spaced 5 to 10 days apart. The intensity will be adjusted according to the subject's feedback, up to 100% of the individual's motor threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Change in Mental Well-Being | The change in the score obtained from the Warwick Edinburgh Mental Well-being 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 14 to 70 and higher scores indicate greater mental well-being. An improvement is defined as an increase in score. | 15 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Medical | Gilbert | Arizona | 85296 | United States | ||
| Luxury Psychiatry Medical and Spa |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 15 months |
| Assessment of Satisfaction | Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction & Mental Wellness 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 |
| 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 |
| Winter Garden |
| Florida |
| 34787 |
| United States |
| Yael Halaas, M.D., F.A.C.S. | New York | New York | 10022 | United States |