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

• Sponsor: Wave Neuroscience (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01683019
• Collaborator: (none)
• Enrollment: 52
• Locations: 2
• Arms: 3
• Duration (Months): 6
• Patients Per Site: 26
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Device: NeoSync EEG Synchronization Therapy; Device: Sham NeoSync EEG Synchronization Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Fixed Alpha Frequency Magnetic Stimulation Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).	Device: 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.
Active Comparator: Active Random Frequency Magnetic Stimulation Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.	Device: 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.
Sham Comparator: Inactive Sham Treatment Generate sound similar to active treatment, except that no magnetic field is generated.	Device: Sham NeoSync EEG Synchronization Therapy; A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amen Clinic	Newport Beach	California	United States	92660
2	Institute of Mental Health, Peking University	Beijing		China

Sponsors and Collaborators

• Wave Neuroscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wave Neuroscience
• ClinicalTrials.gov Identifier: NCT01683019
• Other Study ID Numbers: NST#002
• First Posted: Sep 11, 2012
• Last Update Posted: Dec 7, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Wave Neuroscience: Depression; magnetic field; alpha frequency; EEG; NeoSync EEG Synchronization Therapy
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

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 Detail	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.

Arm/Group Title	Active Fixed Alpha Frequency Magnetic Stimulation	Active Random Frequency Magnetic Stimulation	Inactive Sham Treatment
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	18	15	19
COMPLETED	16	14	15
NOT COMPLETED	2	1	4

Baseline Characteristics

Arm/Group Title	Active Fixed Alpha Frequency Magnetic Stimulation	Active Random Frequency Magnetic Stimulation	Inactive Sham Treatment	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	18	15	19	52
Age (Count of Participants)
<=18 years	0 0%	1 6.7%	0 0%	1 1.9%
Between 18 and 65 years	17 94.4%	14 93.3%	19 100%	50 96.2%
>=65 years	1 5.6%	0 0%	0 0%	1 1.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.2 (15.1)	40.7 (15.9)	46.3 (12.7)	43.5 (14.2)
Sex: Female, Male (Count of Participants)
Female	9 50%	9 60%	9 47.4%	27 51.9%
Male	9 50%	6 40%	10 52.6%	25 48.1%
Region of Enrollment (participants) [Number]
United States	5 27.8%	5 33.3%	5 26.3%	15 28.8%
China	13 72.2%	10 66.7%	14 73.7%	37 71.2%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Active Fixed Alpha Frequency Magnetic Stimulation	Active Random Frequency Magnetic Stimulation	Inactive Sham Treatment
Arm/Group Description	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.	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.	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.
Measure Participants	16	14	15
Mean (Standard Error) [% change in HAM-D score]	-53.8 (27.8)	-53.1 (26.9)	-24.2 (24.2)

Adverse Events

Arm/Group Title	Active Fixed Alpha Frequency Magnetic Stimulation		Active Random Frequency Magnetic Stimulation		Inactive Sham Treatment
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Active Fixed Alpha Frequency Magnetic Stimulation		Active Random Frequency Magnetic Stimulation		Inactive Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Fixed Alpha Frequency Magnetic Stimulation		Active Random Frequency Magnetic Stimulation		Inactive Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Active Fixed Alpha Frequency Magnetic Stimulation		Active Random Frequency Magnetic Stimulation		Inactive Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.