Trial Outcomes & Findings for Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device (NCT NCT00578383)
NCT ID: NCT00578383
Last Updated: 2016-05-16
Results Overview
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
COMPLETED
NA
107 participants
Once just before and once just after treatment
2016-05-16
Participant Flow
Subjects were recruited from March 2008 though February 2011. They were recruited through flyers distributed around McLean Hospital (Belmont, MA), referral by clinic doctors and direct recruitment on the hospital's units.
Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.
Participant milestones
| Measure |
Bipolar Disorder Active LFMS Treatment
Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Bipolar Disorder Sham LFMS Treatment
Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
Major Depressive Disorder Active LFMS Treatment
Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Major Depressive Disorder Sham LFMS Treatment
Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
19
|
15
|
|
Overall Study
COMPLETED
|
21
|
20
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Baseline characteristics by cohort
| Measure |
Bipolar Disorder Active LFMS Treatment
n=37 Participants
Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Bipolar Disorder Sham LFMS Treatment
n=36 Participants
Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
Major Depressive Disorder Active LFMS Treatment
n=19 Participants
Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Major Depressive Disorder Sham LFMS Treatment
n=15 Participants
Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 14.9 • n=4 Participants
|
42.9 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
19 participants
n=5 Participants
|
15 participants
n=4 Participants
|
107 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=19 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=20 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
|
-8.3 units on a scale
Standard Error 1.0
|
-5.79 units on a scale
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=10 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=9 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
|
-7.19 units on a scale
Standard Error 1.44
|
-4.02 units on a scale
Standard Error 1.54
|
PRIMARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=21 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=20 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
|
-1.18 units on a scale
Standard Error 0.37
|
-1.05 units on a scale
Standard Error 0.35
|
PRIMARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=13 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=9 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
|
-1.33 units on a scale
Standard Error 0.53
|
0.25 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=32 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=29 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
|
-8.13 units on a scale
Standard Error 0.87
|
-5.02 units on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores.
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=34 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=29 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS): Combined Diagnostic Groups.
|
-1.66 units on a scale
Standard Error 0.29
|
-0.60 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=34 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=29 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
|
3.16 units on a scale
Standard Error 0.93
|
-0.94 units on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: once pre and once post LFMS treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=34 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=29 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
|
-7.00 units on a scale
Standard Error 1.02
|
-5.00 units on a scale
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=21 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=20 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
|
4.18 units on a scale
Standard Error 1.37
|
-0.79 units on a scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Once just before and once just after treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=13 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=9 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
|
1.05 units on a scale
Standard Error 1.07
|
-0.63 units on a scale
Standard Error 1.11
|
SECONDARY outcome
Timeframe: once pre and once post LFMS treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=21 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=20 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
|
-7.66 units on a scale
Standard Error 1.45
|
-6.31 units on a scale
Standard Error 1.39
|
SECONDARY outcome
Timeframe: once pre and once post LFMS treatmentPopulation: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Outcome measures
| Measure |
Combined Group Active LFMS Treatment
n=13 Participants
Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Combined Group Sham LFMS Treatment
n=9 Participants
Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
|
-5.28 units on a scale
Standard Error 1.10
|
-3.04 units on a scale
Standard Error 0.63
|
Adverse Events
Bipolar Disorder Active LFMS Treatment
Bipolar Disorder Sham LFMS Treatment
Major Depressive Disorder Active LFMS Treatment
Major Depressive Disorder Sham LFMS Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bipolar Disorder Active LFMS Treatment
n=37 participants at risk
Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Bipolar Disorder Sham LFMS Treatment
n=36 participants at risk
Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
Major Depressive Disorder Active LFMS Treatment
n=19 participants at risk
Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
|
Major Depressive Disorder Sham LFMS Treatment
n=15 participants at risk
Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
|
|---|---|---|---|---|
|
General disorders
dizziness at venepuncture
|
0.00%
0/37 • 2 years, 10 months
participant self report
|
5.6%
2/36 • Number of events 2 • 2 years, 10 months
participant self report
|
0.00%
0/19 • 2 years, 10 months
participant self report
|
0.00%
0/15 • 2 years, 10 months
participant self report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place