Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant.
The primary objective of this study:
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFMS Sham | Sham Comparator | For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. |
|
| LFMS 20 minutes | Active Comparator | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. |
|
| LFMS 60 minutes | Active Comparator | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. |
|
| LFMS 120 min | Other | Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFMS | Device | Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score. | Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more. | Week 1 Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS | Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4". To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11. Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more. |
Not provided
Inclusion Criteria: (Key)
Exclusion Criteria: (Key)
Have failed four or more lifetime adequate ADT treatment regimens (including the ongoing ADT for the current MDE).
Have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
Are deemed to be at significant risk for suicidal behavior
Are unable to lie on their back for the duration of study treatment
Have a lifetime history of:
Have a current DSM-5 diagnosis at the screening visit (Visit 1) of:
Have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
Have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
Have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
Have a lifetime history of seizures or clinically significant electroencephalography abnormalities. A history of childhood febrile seizures is permitted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Atul Pande, MD | Tal Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS Trials | Garden Grove | California | 92845 | United States | ||
| Synergy Escondido |
Not provided
Not provided
Not provided
Not provided
Not provided
Subject screening period was up to 14 days before receiving first study treatment. Subjects were contacted by an independent Massachusetts General Hospital-Clinical Trials Network and Institute (MGH-CTNI) rater to perform the Antidepressant Treatment Response Questionnaire (ATRQ) and SAFER assessments to confirm eligibility.
12clinical study sites in the US recruited 122 subjects that were randomized into the study. The date of first subject enrollment was 03 September 2015 and the date of last subject enrolled was 22 July 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LFMS Sham | For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Week 1 Initial Randommization |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Day 11 (Week 2) |
| Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score | To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates. | Day 42 |
| Lemon Grove |
| California |
| 91945 |
| United States |
| Pacific Trials Partners | Oakland | California | 94612 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| Segal Institute | Lauderhill | Florida | 33319 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Radiant Research | Atlanta | Georgia | 30328 | United States |
| Neurobehavioral-Clinical Research | Canton | Ohio | 44718 | United States |
| Midwest Clinical | Dayton | Ohio | 45417 | United States |
| Future Search Trials | Dallas | Texas | 75231 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| FG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation. |
| FG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation. |
| FG003 | LFMS 120 Min | Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Week 2 Stratification & Re-Randomization |
|
|
| Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LFMS Sham | For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| BG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| BG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| BG003 | LFMS 120 Min | Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | White, Black or African American, Asian | Count of Participants | Participants |
|
| 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 From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score. | Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more. | Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 1 Day 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS | Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4". To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11. Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more. | Only non-responders at end of Day 4 comprise this Wk 2 analysis . (Non-responders were defined as those who didn't reach a decrease in 6-item Hamilton Rating Scale for Depression (HAM-D6) total score of 50% compared to baseline Day 1, Week 1). 41 subjects entered Week 2: 1 subject withdrew consent on Day 8 and was not part of the Full Analysis Set. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 11 (Week 2) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score | To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates. | Subjects who were HAM-D6 Day 4 responders, defined as those subjects who achieved a 50% or greater decrease in their HAM-D6 total score compared to Baseline ( Day1, Wk 1). | Posted | Number | percentage of LFMS responders | Day 42 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4) | The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60. Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score | Full Analysis Set, Week1 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 4 Week 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score | The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert. | Full Analysis Set (Week 1). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 4 Week 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4 | The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome treated Item #2 as random missing data. | Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 4, Week 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4 | The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome treated Incorrect Item #2 where Item #2 data was removed. | Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4 | The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome approach took Incorrect Item #2 and imputed using worst possible value. | Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Day 4, Week 1 |
|
Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx & original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LFMS Sham | For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. | 0 | 79 | 0 | 79 | 20 | 79 |
| EG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. | 0 | 40 | 0 | 40 | 14 | 40 |
| EG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. | 0 | 41 | 0 | 41 | 13 | 41 |
| EG003 | LFMS 120 Min - Week 2 | Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. | 0 | 41 | 0 | 41 | 10 | 41 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headche | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Head Discomfort | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gasrtoenteritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Gasrtoenteritis viral | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infecrion | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ear infection viral | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Traumatic arthropathy | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
The study was not powered for secondary measures. Statistical significance for group-wise comparisons wasn't expected.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Atul Pande, MD, Chief Medical Officer | Tal Medical | apande@talmedical.com |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Lost to Follow-up |
|
| Subject left town on Day 42 |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Superiority |
To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance. |
| Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS & sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score. | Mixed Models Analysis | Week 1 baseline HAM-D6 total score, treatment,visit treatment*visit age, & gender included in model. Visit was the repeated measure within subjects. | 0.859 | P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model. | Superiority | To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance. |
| OG001 | LFMS 120 Min | Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| OG002 | LFMS Sham | For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
| OG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| OG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
| OG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| OG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
| OG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| OG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|
| OG001 | LFMS 20 Minutes | LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
| OG002 | LFMS 60 Minutes | LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. |
|
|
|