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Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)

NCT03012724 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-07-15

No results posted yet for this study

Summary

The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DEVICE

H7-Coil

Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil

DEVICE

H1-Coil

Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Israel

Study Locations

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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 NCT03012724 on ClinicalTrials.gov