CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Active Low Field Magnetic Stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01944644
NCT01944644N/ACompleted
CompareCT.gov

The Effect of Low Field Magnetic Stimulation on Resting State Networks in Major Depressive Disorder

Weill Medical College of Cornell University·interventional·Posted Sep 17, 2013·Updated Sep 17, 2018

In Brief

A clinical study evaluating Active Low Field Magnetic Stimulation and Sham Low Field Magnetic Stimulation for Treatment Resistant Depression. Completed, enrolled 66 participants across 1 site.

Detailed Summary

This is a double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting state fMRI will be performed at baseline and following the third and final treatment session.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartAug 1, 2013
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.8 years ago

Interventions

Active Low Field Magnetic Stimulationdevice

Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.

Sham Low Field Magnetic Stimulationdevice

Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.