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

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ClinicalTrials.gov Identifier: NCT01683019
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : May 5, 2014
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
NeoSync, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder (MDD)
Interventions Device: NeoSync EEG Synchronization Therapy
Device: Sham NeoSync EEG Synchronization Therapy
Enrollment 52
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.
Arm/Group Title Active Fixed Alpha Frequency Magnetic Stimulation Active Random Frequency Magnetic Stimulation Inactive Sham Treatment
Hide 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
Reason Not Completed
Withdrawal by Subject             2             1             4
Arm/Group Title Active Fixed Alpha Frequency Magnetic Stimulation Active Random Frequency Magnetic Stimulation Inactive Sham Treatment Total
Hide 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 Number of Baseline Participants 18 15 19 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 19 participants 52 participants
<=18 years
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.9%
Between 18 and 65 years
17
  94.4%
14
  93.3%
19
 100.0%
50
  96.2%
>=65 years
1
   5.6%
0
   0.0%
0
   0.0%
1
   1.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 19 participants 52 participants
44.2  (15.1) 40.7  (15.9) 46.3  (12.7) 43.5  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 19 participants 52 participants
Female
9
  50.0%
9
  60.0%
9
  47.4%
27
  51.9%
Male
9
  50.0%
6
  40.0%
10
  52.6%
25
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 19 participants 52 participants
United States 5 5 5 15
China 13 10 14 37
1.Primary Outcome
Title Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 16 14 15
Mean (Standard Error)
Unit of Measure: % change in HAM-D score
-53.8  (27.8) -53.1  (26.9) -24.2  (24.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Fixed Alpha Frequency Magnetic Stimulation Active Random Frequency Magnetic Stimulation Inactive Sham Treatment
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Fixed Alpha Frequency Magnetic Stimulation Active Random Frequency Magnetic Stimulation Inactive Sham Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Fixed Alpha Frequency Magnetic Stimulation Active Random Frequency Magnetic Stimulation Inactive Sham Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bill Phillips
Organization: NeoSync, Inc.
Phone: 949-333-2906
EMail: bill@neosync.com
Layout table for additonal information
Responsible Party: NeoSync, Inc.
ClinicalTrials.gov Identifier: NCT01683019     History of Changes
Other Study ID Numbers: NST#002
First Submitted: September 4, 2012
First Posted: September 11, 2012
Results First Submitted: October 28, 2013
Results First Posted: May 5, 2014
Last Update Posted: December 7, 2018