Ignite Creation Date:
2024-05-06 @ 12:54 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01683019
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2012-09-04
Brief Title:
Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
Sponsor:
Wave Neuroscience
Organization:
Wave Neuroscience
Study Overview
Official Title:
A MULTICENTER RANDOMIZED BLINDED SHAM CONTROLLED PARALLEL GROUP TRIAL TO TEST CLINICAL EFFICACY OF LOW FREQUENCY AC MAGNETIC FIELD INDUCED EEG SYNCHRONIZATION IN MAJOR DEPRESSION
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This feasibility study investigates effects of EEG-based low frequency low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder
Detailed Description:
Major Depressive Disorder MDD is associated with functional impairment and disability and results in a significant burden on the affected individual his or her family and society in general Psychopharmacological therapy has been shown to be effective but may be accompanied by significant side effects The investigators propose an alternative model based on the relationship between symptoms brain metabolism and neural activity as recorded with electroencephalography EEG Subjects with MDD often have decreased brain metabolism accompanied by increased EEG activity in the alpha band The investigators hypothesis is that a gentle non-significant risk sinusoidal magnetic field above the subjects scalp which oscillates at precisely his or her Intrinsic Alpha Frequency IAF can take advantage of this relationship to reduce symptoms without the significant side effects associated with pharmaceuticals The investigators propose a 4-week sham controlled randomized double-blind multi-center feasibility study to determine the efficacy of synchronized low energy magnetic fields delivered at the subjects IAF to treat MDD Treatment will be given concomitant to the subjects existing medication and will occur 5 days per week at the clinical site Target enrollment is 45 adult subjects diagnosed with MDD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None