An interventional study of Transcranial Magnetic Stimulation in Epilepsy and Depressions, Refractory, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days.
Device: 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.
Also known as: Mag-Venture Mag-pro, TMS
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post-TMS, 1-month and 6-month follow-up
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.
Time frame: 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up
| Milestone | Low Frequency TMS Intervention |
|---|---|
| Started | 15 |
| Completed | 8 |
| Not completed | 7 |
| Withdrew: Screen fail | 3 |
| Withdrew: Lost to follow-up | 4 |
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.
| average number of seizures | Low Frequency TMS Intervention |
|---|---|
| Baseline | 5.83 (0 to 40) |
| 1-week post-treatment | 0 (0 to 0) |
| 1-month post-treatment | 1.42 (0 to 12) |
| 6-month post-treatment | 1.0 (0 to 6) |
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 | Low Frequency TMS Intervention |
|---|---|
| Percentage of Participants Who Complete the TMS Treatment | 12 |
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.
| adverse events | Low Frequency TMS Intervention |
|---|---|
| Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE). | 1 |
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.
| frontal alpha power ratio R/L | Low Frequency TMS Intervention |
|---|---|
| Baseline alpha power asymmetry | 1.29 ± 0.88 |
| Post-TMS alpha power asymmetry | 1.10 ± 0.21 |
| 1-Month Follow-up alpha power asymmetry | 1.35 ± 0.53 |
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.
| score on a scale | Low Frequency TMS Intervention |
|---|---|
| Screening Visit | 16.9 (9 to 21) |
| 1-week post treatment | 8.2 (2 to 15) |
| 1-month post treatment | 8.7 (3 to 17) |
| 3-month post-treatment | 8.8 (3 to 19) |
| 6-month post-treatment | 9.6 (3 to 14) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Frequency TMS Intervention | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Low Frequency TMS Intervention |
|---|---|
| Mild HeadacheGeneral disorders | 11/12 |
| Eye PainGeneral disorders | 4/12 |
| FatigueGeneral disorders | 3/12 |
| Lower Back PainMusculoskeletal and connective tissue disorders | 2/12 |
| NauseaGastrointestinal disorders | 1/12 |
| Bilateral Ear DiscomfortGeneral disorders | 1/12 |
| Blurry VisionGeneral disorders | 1/12 |
| LightheadednessGeneral disorders | 1/12 |
Patients that were enrolled.
| Age, Categorical(Participants) | Low Frequency TMS Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Low Frequency TMS Intervention |
|---|---|
| Female | 8 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Low Frequency TMS Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Low Frequency TMS Intervention |
|---|---|
| United States | 12 |
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Plan to share: No — Individual participant data will be de-identified and then available upon request from PI.
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Dartmouth-Hitchcock Medical Center