Evaluation of the Long Term Efficacy and Durability of the BrainsWay Deep TMS in OCD Subjects

NCT05404360 | Unknown FDA Device

• 1 other identifier: CTP-OCD-02
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Yale Brown Obsessive Compulsive Scale (YBOCS)

  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).

  6 weeks

• Yale Brown Obsessive Compulsive Scale (YBOCS)

  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).

  13 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Sham Control Group

SHAM COMPARATOR

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

Interventions

BrainsWay Deep TMS HAC/H7-Coil DEVICE

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.

Also known as: Active Treatment

Treatment Group

BrainsWay Deep TMS Sham Coil DEVICE

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.

Sham Control Group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brainsway: lead

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Ahava Stein

CONTACT

97297670002; ahava@asteinrac.com

Lisa Bokobza

CONTACT

97297670002; lisa@asteinrac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treatment administrator, all study personnel and patients will be blinded to the treatment being administrated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07