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Brainsway DTMS for Treatment of MDD Using iTBS

NCT04679753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2020-12-23

No results posted yet for this study

Summary

The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.

Conditions

Interventions

DEVICE

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Brainsway DTMS with iTBS

DEVICE

Brainsway DTMS with High Frequency (HF) Stimulation

Brainsway DTMS with HF

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Principal Investigators

  • Oluremi Adefolarin, MD · SynapseTMS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-07-01
Completion
2020-07-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04679753 on ClinicalTrials.gov