rTMS Device for Improvement of Obsessive and Compulsive Behaviors

NCT07679750 | Not Yet Recruiting FDA Device

• 1 other identifier: BTL-699_CTUS1100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Obsessive-Compulsive Behavior

Keywords

rTMS; Obsessive-Compulsive Behavior; EXOMIND; Accelerated protocol; Trigger recall; Adults; ExoTMS; Medical device

Outcome Measures

Primary Outcomes (1)

• 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.

  15 month

Secondary Outcomes (7)

• Evaluation of Change in Self- Reported Impulsivity in Adults

  15 months

• Evaluation of Change in Self-Reported Well-Being in Adults

  15 months

• Evaluation of Change in Self-Reported Depression Severity in Adults

  15 months

• Evaluation of Satisfaction

  15 months

• Evaluation of Therapy Comfort

  15 months

Study Arms (2)

Active treatment with BTL-699-2

EXPERIMENTAL

Participants will receive active treatment (BTL-699-2 intensity: up to 80% of MT)

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)

Device: EXOMIND (BTL-699-2) Sham treatment

Interventions

EXOMIND (BTL-699-2) Active treatment DEVICE

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.

Active treatment with BTL-699-2

EXOMIND (BTL-699-2) Sham treatment DEVICE

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.

Sham treatment with BTL-699-2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Contour Medical

Gilbert, Arizona, 85296, United States

Location

Luxury Psychiatry Clinic

Winter Garden, Florida, 34787, United States

Location

Aesthetic + Mind

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Compulsive Behavior

Condition Hierarchy (Ancestors)

Impulsive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)