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

NCT05404360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-07-20

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404360 on ClinicalTrials.gov