rTMS Device for Improvement of Obsessive and Compulsive Behaviors

N/ANot Yet RecruitingNCT07679750

BTL Industries Ltd.60 enrolled

Overview

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

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.

Interventions

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.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

rTMS Device for Improvement of Obsessive and Compulsive Behaviors

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes