NCT05404360

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-06-03
• Last updated: 2022-07-20

Regulatory

• FDA-regulated device study