EXOMIND Device for OCD

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: BTL Industries Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

This trial is for adults aged 22 and older who have obsessive-compulsive disorder (OCD).

Inclusion Criteria

I am willing to avoid other OCD treatments during the study.
Women of child-bearing potential required to use birth control measures during the whole duration of the study
Voluntarily signed an informed consent form
See 5 more

Exclusion Criteria

Device specific: Implanted stimulator devices including deep brain stimulators, cochlear implants, ocular implants, vagus nerve stimulators
Device specific: Application in the heart area
I have heart disease that is not well controlled.
See 22 more

What Are the Treatments Tested in This Trial?

Interventions

  • EXOMIND (BTL-699-2) Active treatment

Trial Overview

The study tests the EXOMIND (BTL-699-2) device, which uses repetitive transcranial magnetic stimulation (rTMS), to see if it can safely reduce OCD symptoms. Participants are randomly assigned to receive either real or sham (inactive) treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatment with BTL-699-2Experimental Treatment1 Intervention
Group II: Sham treatment with BTL-699-2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials
59
Recruited
2,000+