MedDataX Logo

Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression

NCT ID: NCT01683019

Last Updated: 2018-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 subject's 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 subject's IAF to treat MDD. Treatment will be given concomitant to the subject's existing medication, and will occur 5 days per week at the clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder (MDD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression magnetic field alpha frequency EEG NeoSync EEG Synchronization Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Fixed Alpha Frequency Magnetic Stimulation

Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).

Group Type ACTIVE_COMPARATOR

NeoSync EEG Synchronization Therapy

Intervention Type DEVICE

Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.

Active Random Frequency Magnetic Stimulation

Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.

Group Type ACTIVE_COMPARATOR

NeoSync EEG Synchronization Therapy

Intervention Type DEVICE

Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.

Inactive Sham Treatment

Generate sound similar to active treatment, except that no magnetic field is generated.

Group Type SHAM_COMPARATOR

Sham NeoSync EEG Synchronization Therapy

Intervention Type DEVICE

A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NeoSync EEG Synchronization Therapy

Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.

Intervention Type DEVICE

Sham NeoSync EEG Synchronization Therapy

A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older
* Diagnosis of MDD with HAMD-17 greater than or equal to 17
* On a stable dose of existing medication or no medication for 1 month or longer prior to the study

Exclusion Criteria

* Diagnosed with another primary Axis I illness
* Recent history of or current substance abuse
* Clinically significant medical illness, including any thyroid disorders
* Known pregnancy and/or lactation, or intent to become pregnant during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wave Neuroscience

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amen Clinic

Newport Beach, California, United States

Site Status

Institute of Mental Health, Peking University

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China

References

Explore related publications, articles, or registry entries linked to this study.

Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.

Reference Type DERIVED
PMID: 24438321 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NST#002

Identifier Type: -

Identifier Source: org_study_id