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Trial record 1 of 1 for:    NCT05404360
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Evaluation of the Long Term Efficacy and Durability of the BrainsWay Deep TMS in OCD Subjects

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ClinicalTrials.gov Identifier: NCT05404360
Recruitment Status : Not yet recruiting
First Posted : June 3, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Brainsway

Brief Summary:
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: BrainsWay Deep TMS HAC/H7-Coil Device: BrainsWay Deep TMS Sham Coil Not Applicable

Detailed Description:
The study is a randomized, double-blind, multi-center trial comparing active Deep TMS treatment to sham treatment over the course of the trial. The treatment phase will consist of 44 treatments over thirteen weeks. The acute treatment phase will consist five daily treatments over the course of six weeks, followed by twice weekly continuation treatments for seven weeks. Responders will be eligible to enter the durability phase. For assessment of durability, responders will be assessed quarterly for up to one year from the end of the treatment phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The BrainsWay Deep TMS device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The treatment administrator, all study personnel and patients will be blinded to the treatment being administrated.
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
During the acute treatment phase, subjects will receive daily prefrontal Deep TMS treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly Deep TMS stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks.
Device: BrainsWay Deep TMS HAC/H7-Coil
The BrainsWay HAC/H7-Coil Deep TMS System is composed of four main components: an electromagnetic H7/HAC-Coil, TMS stimulator, cooling system and positioning arm.
Other Name: Active Treatment

Sham Comparator: Sham Control Group
During the acute treatment phase, subjects will receive daily prefrontal sham treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly sham stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks.
Device: BrainsWay Deep TMS Sham Coil

The experimental system has two coils in the same helmet, a sham and active coil.

The sham coil has a similar acoustic artifact as the active coil and it administers a superficial stimulation to maintain blinding. The system assigns the active or sham coil based on the patient ID during the high frequency treatment.





Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 6 weeks ]

    Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups.

    Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).


  2. Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 13 weeks ]

    Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups.

    Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Males and females, 18-88 years of age
  • Diagnosed as suffering from OCD according to the DSM-V.
  • Subjects with a YBOCS score of >20.
  • If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
  • If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
  • Have negative or justified responses by the investigator to all questions listed on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
  • According to the treating physician the subject is compliant with taking medication, if applicable.
  • Subject is capable and willing to provide informed consent and assent.
  • Willing and able to adhere to the treatment schedule.
  • Must own a smartphone.
  • All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.

Exclusion Criteria:

  • Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
  • Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
  • Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
  • History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
  • History of head injury necessitating cranial surgery or prolonged coma.
  • History of any ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
  • Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
  • History of significant hearing loss.
  • Subjects with significant neurological disorder or insult including, but not limited to
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion
  • History of cerebrovascular accident
  • Transient ischemic attack within two years
  • Cerebral aneurysm
  • Multiple sclerosis
  • Substance use disorder within the past 6 months (except nicotine and caffeine).
  • Currently participating in another therapeutic clinical study.
  • Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
  • Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
  • Significant possibility of death within eighteen months of baseline.
  • Planned surgeries that will interrupt the study schedule within eighteen months of baseline
  • Treatment with any TMS in the past year.
  • Women who are breast-feeding.
  • Women who are pregnant or with suspected pregnancy.
  • Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05404360


Contacts
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Contact: Ahava Stein 97297670002 ahava@asteinrac.com
Contact: Lisa Bokobza 97297670002 lisa@asteinrac.com

Sponsors and Collaborators
Brainsway
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Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT05404360    
Other Study ID Numbers: CTP-OCD-02
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Mental Disorders
Anxiety Disorders