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| Name | Class |
|---|---|
| The Diamond Foundation Inc. | OTHER |
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The purpose of this study is to determine if low-frequency transcranial magnetic stimulation (TMS) is safe and feasible for treating depressive symptoms in patients with epilepsy. Patients will receive an accelerated protocol of TMS consisting of three consecutive days of treatment. Patients will have in-person follow up visits after one month and again after six months.
This is a pilot study designed primarily to assess whether patients with epilepsy can safely tolerate low-frequency transcranial magnetic stimulation in an accelerated protocol to treat depression. The investigators aim to treat 12 patients with epilepsy and comorbid depression to receive a total of 15 hours of transcranial magnetic stimulation over 3 days at Dartmouth-Hitchcock Medical Center (DHMC). The investigators will assess safety of this protocol with regards to seizure frequency and other side effects of TMS treatment and the feasibility of using an accelerated protocol in this patient population. In addition to these primary aims, our secondary goal is to determine if dense array EEG can provide a useful biomarker for depression and its treatment in focal epilepsy. A structural and functional MRI will be obtained before treatment and a dense array EEG before and after TMS treatment to assess for changes in specific dense array EEG based biomarkers.
In addition to recruiting patients, the study staff will likewise request that family members or friends of the patient accompany the patient monitor him/her for increased seizure frequency. The recruited family member will bring the patient to the treatment and stay with the patient overnight at a local hotel and monitor for possible seizures or other adverse events of treatment. Family members will be instructed in seizure safety and be given emergency phone numbers to call if the patient is experiencing adverse effects of TMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Frequency TMS Intervention | Experimental | Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study. | The hypothesis is that TMS treatment will not produce serious adverse events defined as an increase in the average number of seizures across all participants. This data is collected from the time of enrollment, and then at baseline, 1-week post treatment, 1-month post-treatment, and 6-month post treatment. The seizures are reported directly by the participants during check-ins with the research staff at the study specified study timepoints. | Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up |
| Percentage of Participants Who Complete the TMS Treatment | The percentage of participants who completed the TMS treatment as measured by the total number of participants (expressed as percentage) who completed 15-hour sessions of TMS over 3 days. | 15 one-hour sessions of TMS over 3 days |
| Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE). | The hypothesis is that TMS treatment will not be associated with a higher rate of adverse events as measured by a modified Systematic Assessment for Treatment Emergent Events (SAFTEE) given pre-TMS treatment and immediately post-TMS sessions. SAFTEE is a tool used to assess participants' adverse events and is presented to all participants before and right after each TMS session. The outcome is expressed as a total number of adverse events across all participants and all TMS treatment sessions. | Day 1, 2, and 3 of TMS treatment |
| Measuring Biomarker for Depression Using Dense-array EEG | Examine the utility of dense-array electroencephalogram (EEG) as a biological marker (biomarker) of depression and response to treatment with low-frequency transcranial magnetic stimulation (TMS) in patients with Epilepsy. The ratio of alpha power between the right and the left hemispheres is considered an EEG based biomarker for depression. It is obtained by dividing alpha power from the right brain hemisphere divided by alpha power measured from the left brain hemisphere. A ratio higher than 1 (1 infers that both sides of the brain are equal) correlates with depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Depression Severity Related to the Study Interventions. | Exploratory analyses will investigate changes in depression scores as a result of the study protocol and interventions. Quick Inventory of Depressive Symptomology (QIDS) is a self-assessment questionnaire used in this study to measure participants' depression symptoms. For Major Depressive Disorder scores of 0-5 indicate no depression, 6-10 indicates mild depression, 11-15 is moderate depression, 16-20 is severe depression, and 21-27 is very severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krzysztof A. Bujarski, MD | Associate Professor of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Individual participant data will be de-identified and then available upon request from PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Frequency TMS Intervention | Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days. Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients that were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Frequency TMS Intervention | Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days. Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 3 prospective participants were screen fails |
| 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 Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study. | The hypothesis is that TMS treatment will not produce serious adverse events defined as an increase in the average number of seizures across all participants. This data is collected from the time of enrollment, and then at baseline, 1-week post treatment, 1-month post-treatment, and 6-month post treatment. The seizures are reported directly by the participants during check-ins with the research staff at the study specified study timepoints. | Subjects 3 and14 were lost to 6-month follow-up for unknown reasons. Subjects 9 and 13 were lost to 6-month follow-up due to COVID 19. | Posted | Mean | Full Range | average number of seizures | Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up |
|
The adverse events are collected from each participant beginning at the screening visit up to the 6-month follow up visit. The results are expressed as the total number of adverse events recorded from all participants at the above specific study timeframe.
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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 | Low Frequency TMS Intervention | Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days. Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Bujarski, MD | Dartmouth Hitchcock Medical Center | 6036505000 | krzysztof.a.bujarski@hitchcock.org |
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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 | Oct 25, 2019 | Jun 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2020 | Jun 21, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
|
| Baseline, Post-TMS, 1-month and 6-month follow-up |
| 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 3 prospective participants were screen fails | Count of Participants | Participants |
|
| Race (NIH/OMB) | 3 prospective participants were screen fails | Count of Participants | Participants |
|
| Region of Enrollment | 3 prospective participants were screen fails | Number | participants |
|
Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days.
Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain.
|
|
| Primary | Percentage of Participants Who Complete the TMS Treatment | The percentage of participants who completed the TMS treatment as measured by the total number of participants (expressed as percentage) who completed 15-hour sessions of TMS over 3 days. | Participants who started the TMS treatment and completed all sessions | Posted | Count of Participants | Participants | 15 one-hour sessions of TMS over 3 days |
|
|
|
| Primary | Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE). | The hypothesis is that TMS treatment will not be associated with a higher rate of adverse events as measured by a modified Systematic Assessment for Treatment Emergent Events (SAFTEE) given pre-TMS treatment and immediately post-TMS sessions. SAFTEE is a tool used to assess participants' adverse events and is presented to all participants before and right after each TMS session. The outcome is expressed as a total number of adverse events across all participants and all TMS treatment sessions. | Posted | Number | adverse events | Day 1, 2, and 3 of TMS treatment |
|
|
|
| Primary | Measuring Biomarker for Depression Using Dense-array EEG | Examine the utility of dense-array electroencephalogram (EEG) as a biological marker (biomarker) of depression and response to treatment with low-frequency transcranial magnetic stimulation (TMS) in patients with Epilepsy. The ratio of alpha power between the right and the left hemispheres is considered an EEG based biomarker for depression. It is obtained by dividing alpha power from the right brain hemisphere divided by alpha power measured from the left brain hemisphere. A ratio higher than 1 (1 infers that both sides of the brain are equal) correlates with depression. | Subject 1: post-TMS HD-EEG data file is not retrievable. Subject 3 and 4: baseline and post-TMS data were too noisy for analysis in frequency domain, and therefore, were excluded from the following analysis. 6-month follow-up: was not collected for this outcome measure due to COVID-19 pandemic | Posted | Mean | Standard Deviation | frontal alpha power ratio R/L | Baseline, Post-TMS, 1-month and 6-month follow-up |
|
|
|
| Secondary | Changes in Depression Severity Related to the Study Interventions. | Exploratory analyses will investigate changes in depression scores as a result of the study protocol and interventions. Quick Inventory of Depressive Symptomology (QIDS) is a self-assessment questionnaire used in this study to measure participants' depression symptoms. For Major Depressive Disorder scores of 0-5 indicate no depression, 6-10 indicates mild depression, 11-15 is moderate depression, 16-20 is severe depression, and 21-27 is very severe depression. | 3-month follow-up: subjects 1 & 2: data not available as this was not in the protocol at the time 6-month follow-up: subjects 3, 9, 13, 14: lost to follow-up, no data available for analysis | Posted | Mean | Full Range | score on a scale | 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| Mild Headache | General disorders | Non-systematic Assessment |
|
| Eye Pain | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bilateral Ear Discomfort | General disorders | Non-systematic Assessment |
|
| Blurry Vision | General disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
|
| 1-Month Follow-up alpha power asymmetry |
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| 1-month post treatment |
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| 3-month post-treatment |
|
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| 6-month post-treatment |
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