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
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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