Trial Outcomes & Findings for Low Field Magnetic Stimulation for Treatment Resistant Depression (NCT NCT01944644)
NCT ID: NCT01944644
Last Updated: 2018-09-17
Results Overview
This is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
7 days after baseline
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Active Low Field Magnetic Stimulation
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Field Magnetic Stimulation for Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Active Low Field Magnetic Stimulation
n=34 Participants
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 Participants
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Hamilton Scale for Depression (HamD) 6 Item
|
11.8 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
11.6 units on a scale
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Visual Analog Scale
|
55.4 units on a scale
STANDARD_DEVIATION 19.9 • n=5 Participants
|
49.9 units on a scale
STANDARD_DEVIATION 21.8 • n=7 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
Positive and Negative Affect Score (PANAS) - Negative Subscale
|
23.7 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 8.9 • n=7 Participants
|
25.6 units on a scale
STANDARD_DEVIATION 8.25 • n=5 Participants
|
|
Positive and Negative Affect Score (PANAS) - Positive Subscale
|
23.1 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 8.0 • n=7 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after baselineThis is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=34 Participants
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 Participants
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
6 Item Hamilton Depression Rating Scale
|
7.4 units on a scale
Standard Deviation 3.4
|
7.6 units on a scale
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: 7 days after baselineA Visual Analog Scale is a measurement of subjective characteristics that cannot be directly measured. Using this self questionnaire, subjects specify their level of depression along a continuous line between two end-points ranging from 0-100 (higher score means better mood).
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=34 Participants
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 Participants
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
Visual Analog Scale
|
74 units on a scale
Standard Deviation 20.6
|
59.4 units on a scale
Standard Deviation 26.2
|
PRIMARY outcome
Timeframe: 7 days after baselineThe Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This negative subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=34 Participants
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 Participants
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
Positive and Negative Affect Score (PANAS) - Negative Subscale
|
15.8 units on a scale
Standard Deviation 7.2
|
18.6 units on a scale
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: 7 days after baselineThe Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This positive subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=34 Participants
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 Participants
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
Positive and Negative Affect Score (PANAS) - Positive Subscale
|
24.8 units on a scale
Standard Deviation 8.7
|
25.5 units on a scale
Standard Deviation 11.9
|
Adverse Events
Active Low Field Magnetic Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Sham Low Field Magnetic Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Low Field Magnetic Stimulation
n=34 participants at risk
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Active Low Field Magnetic Stimulation: Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
|
Sham Low Field Magnetic Stimulation
n=32 participants at risk
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Sham Low Field Magnetic Stimulation: Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
|
|---|---|---|
|
Psychiatric disorders
Panic Attack
|
2.9%
1/34 • Number of events 1 • 7 days.
|
0.00%
0/32 • 7 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place