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Limited resources and funding resulted in a decision to prematurely halt study and redirect remaining funds to partner study Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression (Protocol #2017P002783).
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The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar depression. The investigators also aim to assess any cognitive benefits from regular LFMS treatments in older adults suffering from bipolar depression.
The investigators have previously observed mood improvement in participants with bipolar depression in a population aged 21-60. Here the investigators hope to extend these results to a similar but new population, geriatric bipolar depression (GPD). In addition to the evaluation of the effect of multiple treatments, as well as observation of the duration of the effect after a delay of one week in this population, the investigators will assess whether this population presents any noticeable difference in tolerance or effect.
This study was completed in two phases; the design of the second phase was revised based on results from a related study (2012P002380). The first phase had a randomized, double-blind, sham-controlled crossover design. Subjects were distributed equally into two groups; one group received three active LFMS sessions during a first treatment week and three sham LFMS sessions during a second treatment week, while the second group received sham LFMS first and then active LFMS. Specifically, all subjects made a baseline visit during week 0 (visit 1, any day) where scales of depression (Montgomery-Asberg Rating Scale (MADRS)), anxiety (Hamilton Anxiety Rating Scale (HARS)), and positive affect (Positive and Negative Affect Schedule (PANAS)) were completed. Subjects returned during week 1 for three treatment visits (visits 2,3,4 any days) during which they received active or sham LFMS according to their order assignment. Subject returned for the same mood ratings during week 2 (visit 5, any day). Subjects returned during week 3 for three treatment visits and received the alternate treatment according to their order assignment (visits 6,7,8, any days). Finally, subjects returned week 4 for to receive the mood ratings (visit 9, any day). The MADRS, HARS, and PANAS scales completed during weeks 0, 2, and 4 were the outcome measures. Treatment order assignments were randomized and balanced within blocks of 10 via a random number generator.
Following review of data from a different Low Field Magnetic Stimulation study (2012P002380), the study design was revised, and a second phase of this protocol resulted. This is a randomized, double-blind, sham-controlled study with a parallel design (subjects will either receive active treatment or sham treatment for all treatment sessions). Specifically, the MADRS, HARS, and PANAS were completed on baseline visit 1 (day 0, Friday); 5 treatment visits were made on days 3,4,5,6,7 (visits 2-6); a mood rating visit 7 was made on day 10. The MADRS, HARS, and PANAS scales completed during days 0 and 10 were the outcome measures. Treatment order assignments were randomized and balanced within blocks of 10 via a random number generator.
The mechanisms of depression in a geriatric population may differ from those in a younger population. Brain structures and connectivity have changed, and there is the increased risk of comorbid diagnoses such as dementia that might confound treatment and assessment. In this study the investigators hope to extend the findings of LFMS in the general population to directly address the treatment of bipolar depression in a geriatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Cross-Over, Active LFMS first | Experimental | Phase 1 crossover: three 20 minute treatments of active low field magnetic stimulation, once per day for three consecutive days during week 1. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days during week 3. |
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| Phase 1: Cross-Over, Sham LFMS first | Sham Comparator | Phase 1 crossover: three 20 minute treatments of sham low field magnetic stimulation, once per day for three consecutive days during week 1. Then repeat with three 20 minute treatments of active LFMS, once per day for three consecutive days during week 3. |
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| Phase 2: Parallel, Active LFMS | Experimental | Phase 2 parallel: five 20-minute active low field magnetic stimulation treatments, once per day for five consecutive days during week 1. |
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| Phase 2: Parallel, Sham LFMS | Sham Comparator | Phase 2 parallel: five 20-minute sham low field magnetic stimulation treatments, once per day for five consecutive days during week 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Device | Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement. | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
| Change in Hamilton Anxiety Rating Scale (HARS) | The Hamilton Anxiety Rating Scale (HARS) assesses the severity of anxiety symptoms. It is a 14-item scale covering psychic and somatic anxiety. Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Thus, the total score range is 0-56, wither higher scores indicating higher anxiety severity. | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
| Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale | The Positive and Negative Affect Schedule (PANAS) assesses the presence and severity of two factors: positive affect (PA), which indicates the extent that a person is experiencing high energy, enthusiastic, mood state, and negative affect (NA), which indicates the extent a person is experiencing an aversive mood state. The PANAS is a 20-item scale, with 10 items measured PA and 10 items measuring NA. Each item is scored on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Thus, the score range for PA is 10-50, and the score range for NA is 10-50, with higher scores indicated more endorsement of PA (more energy, concentration, and pleasure) or NA (more anger, disgust, contempt). This study reports data on the score ranges for the PA sub-scale. | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent Forester, M.D. MSc. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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Enrolled subjects underwent thorough screening procedures to determine diagnostic status. Two subjects did not meet diagnostic criteria and thus were not assigned to a group. One subject withdrew from the study due to personal reasons before being assigned to a group.
Recruitment spanned from 2017 to 2019. 30 subjects in total were screened, while 16 of those subjects enrolled in the study. All subjects were recruited through the Mass General Brigham Clinical Trials Portal or through referrals via our internal McLean "Successful Aging through Group Engagement" program.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cross-Over Phase; Active LFMS First | Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| FG001 | Cross-Over Phase; Sham LFMS First | Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| FG002 | Parallel Phase; Active LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) |
| FG003 | Parallel Phase; Sham LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population is the same as the assignment in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Cross-Over, Active LFMS First | Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Montgomery Asberg Depression Rating Scale (MADRS) | The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement. | Posted | Mean | Standard Deviation | score on scale | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
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Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active LFMS | Includes subjects in phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days. Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Non-systematic Assessment | headache that resolved spontaneously with cessation of treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Rohan | McLean Hospital | 617-855-3127 | mrohan@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2018 | Sep 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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There are two phases. The first, pilot phase was a randomized, double-blinded crossover design. Following review of data from a different Low Field Magnetic Stimulation study (2012P002380) that showed a large order effect from the crossover design, revision of study design was prompted. The study design for this second phase was a randomized, double-blinded sham-controlled parallel design.
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The system can operate in sham mode, with identical sounds to active mode. The system can be programmed to randomize subjects automatically without the knowledge of study staff.
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| Sham Low Field Magnetic Stimulation | Device | The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment by producing mimicking sounds. |
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| BG001 | Phase 1: Cross-Over, Sham LFMS First | Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| BG002 | Phase 2: Parallel, Active LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) |
| BG003 | Phase 2: Parallel, Sham LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| MADRS Baseline | The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement. | Mean | Standard Deviation | scores on a scale |
|
| HARS Hamilton Anxiety Rating Scale | The Hamilton Anxiety Rating Scale (HARS) assesses the severity of anxiety symptoms. It is a 14-item scale covering psychic and somatic anxiety. Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Thus, the total score range is 0-56, wither higher scores indicating higher anxiety severity. | Mean | Standard Deviation | scores on a scale |
|
| PANAS: Positive and Negative Affect Scale, Positive Subscale | The Positive and Negative Affect Schedule (PANAS) assesses the presence and severity of two factors: positive affect (PA) and negative affect (NA). The PANAS is a 20-item scale, with 10 items measured PA and 10 items measuring NA. Each item is scored on a 5-point scale ranging from 1 (very slightly/not at all) to 5 (extremely). The score range for PA is 10-50, and the score range for NA is 10-50, with higher scores indicated more endorsement of PA (more energy, concentration, and pleasure) or NA (more anger, disgust, contempt). This study reports data on the score ranges for the PA sub-scale. | Mean | Standard Deviation | score on a scale |
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| OG001 | Phase 1: Cross-Over, Sham LFMS First | Sham Low Field Magnetic Stimulation Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
| OG002 | Phase 2: Parallel, Active LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT) |
| OG003 | Phase 2: Parallel, Sham LFMS | Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. |
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| Primary | Change in Hamilton Anxiety Rating Scale (HARS) | The Hamilton Anxiety Rating Scale (HARS) assesses the severity of anxiety symptoms. It is a 14-item scale covering psychic and somatic anxiety. Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Thus, the total score range is 0-56, wither higher scores indicating higher anxiety severity. | Posted | Mean | Standard Deviation | score on a scale | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
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| Primary | Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale | The Positive and Negative Affect Schedule (PANAS) assesses the presence and severity of two factors: positive affect (PA), which indicates the extent that a person is experiencing high energy, enthusiastic, mood state, and negative affect (NA), which indicates the extent a person is experiencing an aversive mood state. The PANAS is a 20-item scale, with 10 items measured PA and 10 items measuring NA. Each item is scored on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Thus, the score range for PA is 10-50, and the score range for NA is 10-50, with higher scores indicated more endorsement of PA (more energy, concentration, and pleasure) or NA (more anger, disgust, contempt). This study reports data on the score ranges for the PA sub-scale. | Posted | Mean | Standard Deviation | score on a scale | Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1. |
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| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Sham LFMS | Includes subjects in phase 1 crossover: three 20 minute treatments of sham LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment. | 0 | 7 | 0 | 7 | 2 | 7 |
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| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Event resolved spontaneously with cessation of treatment |
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| Pressure in Head | Nervous system disorders | Non-systematic Assessment | events resolve spontaneously with cessation of treatment |
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| Sham |
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ANCOVA: Analysis of group differences in change scores with baseline as a covariate |
| ANCOVA |
baseline as covariate |
| <0.32 |
| Mean Difference (Final Values) |
| -4.33 |
| Standard Deviation |
| 4.00 |
| 2-Sided |
pooled deviation |
| Superiority |
| Sham LFMS |
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| ANCOVA: Analysis of group differences in change scores with baseline as a covariate | ANCOVA | baseline as covariate | <0.99 | Mean Difference (Final Values) | -0.33 | Standard Deviation | 2.42 | 2-Sided | pooled deviation | Superiority |