Major Depressive Disorder (MDD)
Conditions
Keywords
Depression, magnetic field, alpha frequency, EEG, NeoSync EEG Synchronization Therapy
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 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.
Interventions
DEVICENeoSync 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.
DEVICESham NeoSync EEG Synchronization Therapy
A device that looks and sounds similar to the active treatment, but no magnetic field is generated.
Sponsors
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | Assessed 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. |
Countries
China, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 15 |
| 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. | 19 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Active Fixed Alpha Frequency Magnetic Stimulation | Active Random Frequency Magnetic Stimulation | Inactive Sham Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 14 Participants | 19 Participants | 50 Participants |
| Age, Continuous | 44.2 years STANDARD_DEVIATION 15.1 | 40.7 years STANDARD_DEVIATION 15.9 | 46.3 years STANDARD_DEVIATION 12.7 | 43.5 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment China | 13 participants | 10 participants | 14 participants | 37 participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 | 0 / 15 |
Outcome results
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.
Time frame: Assessed at baseline and the end of Week 4 of treatment.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Fixed Alpha Frequency Magnetic Stimulation | Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | -53.8 % change in HAM-D score | Standard Error 27.8 |
| Active Random Frequency Magnetic Stimulation | Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | -53.1 % change in HAM-D score | Standard Error 26.9 |
| Inactive Sham Treatment | Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. | -24.2 % change in HAM-D score | Standard Error 24.2 |