rTMS Device for Improvement of Obsessive and Compulsive Behaviors
ConditionObsessive-Compulsive Behavior
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBTL Industries Ltd.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EXOMIND (BTL-699-2) Active treatment
DeviceParticipants 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 treatment
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active treatment with BTL-699-2Experimental treatment 1 intervention
Group B: Sham treatment with BTL-699-2Sham comparator 1 intervention
Trial outcomes
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.
Time frame
15 monthSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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