An interventional study of EXOMIND (BTL-699-2) Active treatment and EXOMIND (BTL-699-2) Sham treatment in Obsessive-Compulsive Behavior, sponsored by BTL Industries Ltd.. Not yet recruiting at 3 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
This is a prospective, interventional, multi-centre, single-blinded, two-arm study. The subjects will be enrolled and randomly 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 active treatment (BTL-699-2 with intensity up to 80% of the individual's motor threshold (MT), and Group B will receive sham treatment (BTL-699-2 with intensity of 5% of the individual's MT).
The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR), Short UPPS-P Impulsive Behavior Scale (SUPPS-P), The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Columbia Suicide Severity Rating Scale -screen version(CSSRS) and the urinary pregnancy test will be given to the subjects at baseline, at the last treatment visit, at the 1-month and at 3-month follow-up visits. The Patient Health Questionnaire-9 (PHQ-9) will be administered at baseline, after the second, fourth, and last treatment visits, at the 1-month and 3-month follow-up visits. The Trigger Recall Experience Questionnaire (TREQ) will be conducted at the end of each treatment session only for participants who voluntarily choose to engage in trigger recall procedure. Therapy Comfort questionnaires will be given to the subjects after the last treatment. Subject Satisfaction Questionnaire will be given to the subjects after the last treatment, and at both 1-month and 3-month follow-ups.
The approximate subject participation duration is six (6) months after the enrollment.
30 studies on the registry are indexed under Compulsive Behavior; 6 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 27 interventional studies indexed under Compulsive Behavior.
Browse Compulsive Behavior 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:
Device specific:
Study specific:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Participants will receive active treatment (BTL-699-2 intensity: up to 80% of MT)
Device: EXOMIND (BTL-699-2) Active treatment
Participants will receive sham treatment (BTL-699-2 intensity: 5% of MT)
Device: 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 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.
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.
The Evaluation of the Change in Obsessive-Compulsive Behaviours in Adults
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.
Time frame: 15 month
Evaluation of Change in Self- Reported Impulsivity in Adults
The change in the score obtained from the self-reported Short UPPS-P Impulsive Behavior Scale (SUPPS-P). The baseline score will be compared to the 3-months follow-up visit. The questionnaire includes 20 items relating aspects of impulsive personality and total score ranges from 20 to 80 with higher scores indicating higher levels of impulsivity. Improvement is considered a decrease in the obtained score.
Time frame: 15 months
Evaluation of Change in Self-Reported Well-Being in Adults
The change in the score obtained from the self-reported Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The baseline score will be compared to the 1-month follow-up score. The total score ranges from 14 to 70, with higher scores indicating greater mental well-being and quality of life. Improvement is considered an increase in the obtained score.
Time frame: 15 months
Evaluation of Change in Self-Reported Depression Severity in Adults
The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 3-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Time frame: 15 months
Evaluation 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
Evaluation of Therapy Comfort
Therapy Comfort questionnaire consist of two questions and will be used for evaluating the comfort and pain during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. The first 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. The second question 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 obsessive and compulsive behaviors and to identify side effects and adverse events associated with the study treatment.
Time frame: 15 months
The subject-reported experience during trigger recall procedure
The Trigger Recall Experience Questionnaire (TREQ) is a self-administered questionnaire fill out at the end of each treatment session to evaluate subjective experiences of participants, who voluntarily engage in the trigger recall procedure. The questionnaire consists of 5 questions: one question (2nd question) utilizes a checklist with a list of specific thoughts and physical sensations, and the remaining four use Numerical Rating Scales (0 = none, 10 = maximum). It assesses three independent domains: 1) urge intensity(1st question), 2) emotional manageability(3rd and 4th question), and 3) sense of control(5th question). For urge intensity, a lower score indicates a lower strength of urges. For emotional manageability and sense of control, a higher score indicates greater manageability and control.
Time frame: 15 month
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.