Trial Outcomes & Findings for Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression (NCT NCT01929681)

Results Overview

The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

Variable based on screening visit schedule, > 2 weeks.

Results posted on

2017-09-26

Participant Flow

Recruitment was performed through newspaper advertisement, posting, and referral

Subjects that failed exclusion criteria for variable criteria such as medications change or drug use were permitted to reapply for participation after a washout period of at least 1 month.

Participant milestones

Participant milestones
Measure	LFMS - Active Treatment Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Overall Study STARTED	28	25
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LFMS - Active Treatment Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	1

Baseline Characteristics

Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LFMS - Active Treatment n=28 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=25 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	Total n=53 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 13.5 • n=5 Participants	45.7 years STANDARD_DEVIATION 10.3 • n=7 Participants	45.1 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	28.2 units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants	27.4 units on a scale STANDARD_DEVIATION 5.0 • n=7 Participants	27.8 units on a scale STANDARD_DEVIATION 5.4 • n=5 Participants

PRIMARY outcome

Timeframe: Variable based on screening visit schedule, > 2 weeks.

Population: Subjects completing 3 treatments and 1 visit

The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.

Outcome measures

Outcome measures
Measure	LFMS - Active Treatment n=26 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)	-14.03 units on a scale Standard Deviation 7.85	-9.75 units on a scale Standard Deviation 9.32

PRIMARY outcome

Timeframe: 90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.

Population: subjects completing 3 treatment visits and 1 followup visit

PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (\<30min) prior to the first treatment and immediately after (\<30min) the first treatment.

Outcome measures

Outcome measures
Measure	LFMS - Active Treatment n=26 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale	0.5 units on a scale Standard Deviation 5.8	1.4 units on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: Over 3 days of treatment

Population: Subjects completing 3 treatments and 1 visit

PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (\<30min oost treatment) minus pre (\<30min pre treatment) score differences for the three treatment days

Outcome measures

Outcome measures
Measure	LFMS - Active Treatment n=26 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 2 mean	-0.63 units on a scale Standard Error 0.68	0.21 units on a scale Standard Error 0.91
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale linear coefficient	-0.471 units on a scale Standard Error 0.594	-0.375 units on a scale Standard Error 0.648
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 1 mean	0.50 units on a scale Standard Error 1.14	1.40 units on a scale Standard Error 1.09
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 3 mean	-0.44 units on a scale Standard Error 0.65	0.65 units on a scale Standard Error 0.77

SECONDARY outcome

Timeframe: Over 3 days of treatment

Population: Subjects completing 3 treatments and 1 visit

The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days

Outcome measures

Outcome measures
Measure	LFMS - Active Treatment n=26 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS) day 2 mean	16.81 units on a scale Standard Error 1.31	17.83 units on a scale Standard Error 1.45
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS) linear coefficient	-5.42 units on a scale Standard Error 1.07	-5.60 units on a scale Standard Error 1.07
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS) day 1 mean	26.15 units on a scale Standard Error 1.47	26.13 units on a scale Standard Error 1.44
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS) day 3 mean	15.31 units on a scale Standard Error 1.69	14.92 units on a scale Standard Error 1.66

SECONDARY outcome

Timeframe: Over 3 days of treatment

Population: Subjects completing 3 treatments and 1 visit

PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days

Outcome measures

Outcome measures
Measure	LFMS - Active Treatment n=26 Participants Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 Participants Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale linear coefficient	1.70 units on a scale Standard Error 1.39	0.80 units on a scale Standard Error 1.10
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 2 mean	24.04 units on a scale Standard Error 1.95	23.54 units on a scale Standard Error 1.53
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 3 mean	24.40 units on a scale Standard Error 2.21	23.85 units on a scale Standard Error 1.84
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale day 1 mean	21.00 units on a scale Standard Error 1.82	22.25 units on a scale Standard Error 1.34

Adverse Events

LFMS - Active Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LFMS - 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

Other adverse events
Measure	LFMS - Active Treatment n=26 participants at risk Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.	LFMS - Sham Treatment n=24 participants at risk Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present. Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Psychiatric disorders insomnia	3.8% 1/26 • Number of events 1 • Adverse events data was collected over a period of 3 years.	0.00% 0/24 • Adverse events data was collected over a period of 3 years.

Additional Information

Dr. Michael Rohan

McLean Hospital

Phone: 617-855-3127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place