Obsessive-Compulsive BehaviorNCT07679750
rTMS Device for Improvement of Obsessive and Compulsive Behaviors
A study testing EXOMIND (BTL-699-2) Active treatment in people with Obsessive-Compulsive Behavior, run by BTL Industries Ltd. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Behavior
- What is being tested?
- EXOMIND (BTL-699-2) Active treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 22 years and older
- Voluntarily signed an informed consent form
- Current presence of obsessive-compulsive behaviors of at least mild severity, defined as a Y-BOCS-II Self-Report total score ≥15.
- Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of obsessive-compulsive behaviours, including non-invasive brain stimulation treatments other than the study procedure during study participation
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.
- If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and neuropsychiatric prescribed medications (including SSRI or other medication, except for more than 2mg of lorazepam or equivalent) at a stable therapeutic dosage for at least 2 months prior to study entry
- Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
- Willingness to comply with study instructions and to return to the clinic for the required visits *Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Who cannot join
- Device specific:
- Metallic objects in or near the head
- rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil
- Implanted stimulator devices
- rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators.
- Contraindicated use could result in serious injury or death.
Show all 28Show fewer
- Drug pumps
- Application in the heart area
- Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
- Anticoagulation therapy
- Severe or life-threatening condition
- Pulmonary insufficiency
- Heart disorders
- Renal insufficiency
- Decompensated hemorrhagic conditions
- Decompensated blood coagulation disorders
- Decompensated cardiovascular diseases
- Malignant tumor or benign tumor
- Fever
- Pregnancy
- Study specific:
- Active suicidal intent
- Prior treatment with TMS, rTMS, dTMS in the past 6 months or vagus nerve stimulator implant
- Nursing
- Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
- History of increased intracranial pressure
- Current head trauma
- Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Contour Medical
Gilbert, Arizona, 85296
JD McCoy, NMD, (480) 545-2832, dr_jdmccoy@mac.com
Aesthetic + Mind
Wellesley, Massachusetts, 02481
Omotola T'Sarumi, MD, 617-668-1239, Info@drtola.com
Luxury Psychiatry Clinic
Winter Garden, Florida, 34787
Michelle Dees, MD, (407) 603-0925, michelledees@hotmail.com
About this study
Official title: Evaluation of the Efficacy and Safety of an Accelerated Protocol for Obsessive and Compulsive Behaviour Using the BTL-699-2 Device
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:
Read more
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
Read the detailed description
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.
- Conditions
- Obsessive-Compulsive Behavior
- Being tested
- EXOMIND (BTL-699-2) Active treatment, EXOMIND (BTL-699-2) Sham treatment
- Keywords
- rTMS, Obsessive-Compulsive Behavior, EXOMIND, Accelerated protocol, Trigger recall, Adults, ExoTMS, Medical device
- Medical subject headings
- Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOMIND (BTL-699-2) Active treatmentDevice
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 treatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Active treatment with BTL-699-2 | Experimental | Participants will receive active treatment (BTL-699-2 intensity: up to 80% of MT) Receives: Device: EXOMIND (BTL-699-2) Active treatment |
| Sham treatment with BTL-699-2 | Sham comparator | Participants will receive sham treatment (BTL-699-2 intensity: 5% of MT) Receives: Device: EXOMIND (BTL-699-2) Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 month
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start24 Jun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679750
- Sponsor's protocol ID
- BTL-699_CTUS1100
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Accelerated Protocol for Obsessive and Compulsive Behaviour Using the BTL-699-2 Device
- ClinicalTrials.gov ID
- NCT07679750
- Acronym / sponsor ID
- BTL-699_CTUS1100
- Conditions
- Obsessive-Compulsive Behavior
- Keywords
- rTMS, Obsessive-Compulsive Behavior, EXOMIND, Accelerated protocol, Trigger recall, Adults, ExoTMS, Medical device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment with BTL-699-2 | Experimental | Device: EXOMIND (BTL-699-2) Active treatmentParticipants will receive active treatment (BTL-699-2 intensity: up to 80% of MT) |
| Sham treatment with BTL-699-2 | Sham comparator | Device: EXOMIND (BTL-699-2) Sham treatmentParticipants will receive sham treatment (BTL-699-2 intensity: 5% of MT) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 22 years and older
- Voluntarily signed an informed consent form
- Current presence of obsessive-compulsive behaviors of at least mild severity, defined as a Y-BOCS-II Self-Report total score ≥15.
- Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of obsessive-compulsive behaviours, including non-invasive brain stimulation treatments other than the study procedure during study participation
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.
Key exclusion criteria (28 listed)
- Metallic objects in or near the head
- rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil
- Implanted stimulator devices
- rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators.
- Contraindicated use could result in serious injury or death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOMIND (BTL-699-2) Active treatmentParticipants 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. | Device | Active treatment with BTL-699-2 |
| EXOMIND (BTL-699-2) Sham treatmentParticipants 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. | Device | Sham treatment with BTL-699-2 |
Primary outcome
The Evaluation of the Change in Obsessive-Compulsive Behaviours in Adults
Time frame: 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.
7 secondary outcomes
Evaluation of Change in Self- Reported Impulsivity in Adults
Time frame: 15 months
Evaluation of Change in Self-Reported Well-Being in Adults
Time frame: 15 months
Evaluation of Change in Self-Reported Depression Severity in Adults
Time frame: 15 months
Evaluation of Satisfaction
Time frame: 15 months
Evaluation of Therapy Comfort
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Time frame: 15 months
The subject-reported experience during trigger recall procedure
Time frame: 15 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOMIND (BTL-699-2) Active treatment in people with Obsessive-Compulsive Behavior, run by BTL Industries Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Evaluation of the Change in Obsessive-Compulsive Behaviours in Adults (time frame: 15 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.