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Trial Outcomes & Findings for Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression (NCT NCT01683019)

NCT ID: NCT01683019

Last Updated: 2018-12-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

Assessed at baseline and the end of Week 4 of treatment.

Results posted on

2018-12-07

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
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.
Overall Study
STARTED
18
15
19
Overall Study
COMPLETED
16
14
15
Overall Study
NOT COMPLETED
2
1
4

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
Overall Study
Withdrawal by Subject
2
1
4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Fixed Alpha Frequency Magnetic Stimulation
n=18 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.
Active Random Frequency Magnetic Stimulation
n=15 Participants
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.
Inactive Sham Treatment
n=19 Participants
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
n=52 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=5 Participants
14 Participants
n=7 Participants
19 Participants
n=5 Participants
50 Participants
n=4 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Continuous
44.2 years
STANDARD_DEVIATION 15.1 • n=5 Participants
40.7 years
STANDARD_DEVIATION 15.9 • n=7 Participants
46.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
43.5 years
STANDARD_DEVIATION 14.2 • n=4 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
9 Participants
n=7 Participants
9 Participants
n=5 Participants
27 Participants
n=4 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
25 Participants
n=4 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
5 participants
n=7 Participants
5 participants
n=5 Participants
15 participants
n=4 Participants
Region of Enrollment
China
13 participants
n=5 Participants
10 participants
n=7 Participants
14 participants
n=5 Participants
37 participants
n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Active Fixed Alpha Frequency Magnetic Stimulation
n=16 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.
Active Random Frequency Magnetic Stimulation
n=14 Participants
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.
Inactive Sham Treatment
n=15 Participants
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.
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
-53.1 % change in HAM-D score
Standard Error 26.9
-24.2 % change in HAM-D score
Standard Error 24.2

Adverse Events

Active Fixed Alpha Frequency Magnetic Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Random Frequency Magnetic Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Inactive Sham Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bill Phillips

NeoSync, Inc.

Phone: 949-333-2906

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place