rTMS Device for Improvement of Obsessive and Compulsive Behaviors
Condition(s) studied
Investigational drug(s) / intervention(s)
EXOMIND (BTL-699-2) Active treatment: Participants will receive twelve transcranial magnetic stimulation treatment sessions during 6 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsomedial prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 80% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
EXOMIND (BTL-699-2) Sham treatment: Participants will receive twelve transcranial magnetic stimulation treatment sessions during 6 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsomedial prefrontal cortex. The intensity will be set to 5% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
Study summary
The goal of this investigational study is to evaluate if the treatment using EXOMIND(BTL-699-2) device is able to improve severity of obsessive and compulsive symptoms in adults (aged 22 and older).
The main question it aims to answer is:
Does the treatment using EXOMIND (BTL-699-2) device is able safely and efficiently reduce the severity of obsessive and compulsive behaviors?
Participants will be asked to:
* Complete six treatment visits (twelve treatment sessions)
* Complete The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR)
* Complete Short UPPS-P Impulsive Behaviour Scale (SUPPS-P)
* Compete The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
* Compete The Patient Health Questionnaire-9 (PHQ-9)
* Compete Columbia Suicide Severity Rating Scale -screen version(CSSRS)
* Complete Trigger Recall Experience Questionnaire (only for participants who agree to participate in trigger recall procedure during the treatment sessions)
* Compete The Therapy Comfort Questionnaire
* Compete The Subject Satisfaction Questionnaire
Eligibility
Primary outcome measure(s)
- The Evaluation of the Change in Obsessive-Compulsive Behaviours in Adults — 15 month
The change in the score obtained from the self-reported The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR). The baseline score will be compared to the 3-month score. The 3-month score change will be compared between the active and sham groups. The total score ranges from 0 to 50, with higher scores indicating greater behavior severity. Improvement is considered a decrease in the obtained score.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Contour Medical | Gilbert | Arizona | |
| Luxury Psychiatry Clinic | Winter Garden | Florida | |
| Aesthetic + Mind | Wellesley | Massachusetts |
More BTL Industries Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07679750 on ClinicalTrials.gov ↗ ← All trials in the USA