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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Fixed Alpha Frequency Magnetic Stimulation | Active Comparator | Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). |
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| Active Random Frequency Magnetic Stimulation | Active Comparator | Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. |
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| Inactive Sham Treatment | Sham Comparator | Generate sound similar to active treatment, except that no magnetic field is generated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoSync EEG Synchronization Therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment. The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression. | Assessed at baseline and the end of Week 4 of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amen Clinic | Newport Beach | California | 92660 | United States | ||
| Institute of Mental Health, Peking University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24438321 | Derived | 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. |
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Following enrollment and completion of informed consent, subjects were randomized to a treatment arm. Subjects were instructed to continue any concomitant medication throughout the treatment period. There was no wash out or transition required.
Subjects were recruited at two separate psychiatric clinics. The recruitment period was between June 9, 2008 and November 5, 2008. Recruitment was accomplished through selection from the normal patient flow at the clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Fixed Alpha Frequency Magnetic Stimulation | Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). 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. |
| FG001 | Active Random Frequency Magnetic Stimulation | Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. 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. |
| FG002 | Inactive Sham Treatment | Generate sound similar to active treatment, except that no magnetic field is generated. Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Fixed Alpha Frequency Magnetic Stimulation | Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment. The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression. | 52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects. | Posted | Mean | Standard Error | % change in HAM-D score | Assessed at baseline and the end of Week 4 of treatment. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Fixed Alpha Frequency Magnetic Stimulation | Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bill Phillips | NeoSync, Inc. | 949-333-2906 | bill@neosync.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Sham NeoSync EEG Synchronization Therapy | Device | A device that looks and sounds similar to the active treatment, but no magnetic field is generated. |
|
| Beijing |
| China |
| BG001 |
| Active Random Frequency Magnetic Stimulation |
Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. 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. |
| BG002 | Inactive Sham Treatment | Generate sound similar to active treatment, except that no magnetic field is generated. Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
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.
| OG001 | Active Random Frequency Magnetic Stimulation | Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. 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. |
| OG002 | Inactive Sham Treatment | Generate sound similar to active treatment, except that no magnetic field is generated. Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated. |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Active Random Frequency Magnetic Stimulation | Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. 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. | 0 | 14 | 0 | 14 |
| EG002 | Inactive Sham Treatment | Generate sound similar to active treatment, except that no magnetic field is generated. Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated. | 0 | 15 | 0 | 15 |
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| D001519 |
| Behavior |