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
Qualifiers
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
Treatments tested in this trial
- EXOMIND (BTL-699-2) Active treatment
- EXOMIND (BTL-699-2) Sham treatment
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov