rTMS Device for Improvement of Obsessive and Compulsive Behaviors

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.

Inclusion criteria

• 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.

Exclusion criteria

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
• 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