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Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

NCT01370733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2015-10-26

Study results available
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Summary

This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.

Conditions

Interventions

DEVICE

NEST-1 (NeoSync EEG Synchronized TMS)

The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

DEVICE

SHAM

The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Sponsors & Collaborators

  • Wave Neuroscience

    lead INDUSTRY

Principal Investigators

  • Andrew Leuchter, MD · UCLA Depression Research & Clinic Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • United States

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 NCT01370733 on ClinicalTrials.gov