rTMS Device for Improvement of Obsessive and Compulsive Behaviors

Starting soon · Not applicable · Has a placebo group

Conditions studied: Obsessive-Compulsive Behavior

In brief

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

Key facts

Study ID

NCT07679750

Run by

BTL Industries Ltd.

People needed

60

Starts

2026-06-24

Expected to finish

2026-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Contour Medical — Gilbert, Arizona, United States
• Luxury Psychiatry Clinic — Winter Garden, Florida, United States
• Aesthetic + Mind — Wellesley, Massachusetts, United States

Full record on ClinicalTrials.gov

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