EpilepsyLFTMSNCT03105700

Low Frequency TMS for Depression in Epilepsy

A study testing Transcranial Magnetic Stimulation in people with Epilepsy and Depressions, Refractory, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Epilepsy, Depressions, Refractory
What is being tested?: Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2017to 15 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 or older
Able and willing to provide informed consent.
Diagnosis of epilepsy confirmed by the study neurologist (KB).
English-speaking
Not pregnant
Able to safely undergo MRI (as assessed by MRI safety form).
Have a family member or friend (proxy) who will be able to bring the patient to the hospital and serve as a safety monitor during stay in study hotel for two consecutive nights.
Patients on stable doses of current antiepileptic and antidepressant medications for 1 month.

Who cannot join

Significant cognitive impairment measured by the Montreal Cognitive Assessment (MOCA) <23.
History of other major psychiatric disorders (e.g., schizophrenia, bipolar disorder, substance use disorder (except caffeine and nicotine) or presence of unstable medical comorbidities.
Actively/imminently suicidal (QIDS item 12 score > 2 or Mini-International Neuropsychiatric Interview (MINI) Suicidality module score > 16)
Greater than 10 seizures per week during 1 month prior.
History of stroke, moderate-severe traumatic brain injury or other major neurological disorder.
Any magnetic or implanted device that will interfere with ability to safely receive MRI and/or TMS treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Safety and Feasibility of Accelerated Low-Frequency Transcranial Magnetic Stimulation for Medication-Resistant Depression in Patients With Epilepsy

Read the detailed description

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.

Conditions: Epilepsy, Depressions, Refractory
Being tested: Transcranial Magnetic Stimulation
Keywords: epilepsy, depression, refractory, TMS
Medical subject headings: Epilepsy, Depressive Disorder, Treatment-Resistant, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Magnetic StimulationDevice
Also called Mag-Venture Mag-pro, TMS
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.

Study groups in NCT03105700
Study group	Role	What they receive
Low Frequency TMS Intervention	Experimental	Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days. Receives: Device: Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-TMS, 1-month and 6-month follow-up

Secondary outcomes (1)

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.
Measured: 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201715 Nov 2021

First posted10 Apr 2017
Study start1 Apr 2017
Primary completion15 Nov 2021
Study completion15 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03105700
Sponsor's protocol ID: D16150
Acronym: LFTMS
Status last verified: Mar 2023
First submitted: 6 Mar 2017
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Individual participant data will be de-identified and then available upon request from PI.

Publications

Bujarski K, Knight J, Song Y, Streltzov N, Castelblanco-Riveros C, Plumber J, Bursey J, Snogren S, Schommer L, Holtzheimer P. Open-label Study of Accelerated Low-Frequency TMS for Treatment-Resistant Depression in People With Epilepsy. Neuromodulation. 2026 Jun 6:S1094-7159(26)00150-9. doi: 10.1016/j.neurom.2026.05.008. Online ahead of print.
PubMed 42747369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Feasibility of Accelerated Low-Frequency Transcranial Magnetic Stimulation for Medication-Resistant Depression in Patients With Epilepsy
ClinicalTrials.gov ID: NCT03105700
Acronym / sponsor ID: LFTMS / D16150
Conditions: Epilepsy, Depressions, Refractory
Keywords: epilepsy, depression, refractory, TMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: The Diamond Foundation Inc.
Study start: 1 Apr 2017 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 15 Nov 2021 (actual)
First posted: 10 Apr 2017 (actual)
Results: Posted 21 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Low Frequency TMS Intervention	Experimental	Device: Transcranial Magnetic StimulationPatients will receive low-frequency TMS on an accelerated schedule over three consecutive days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 or older
Able and willing to provide informed consent.
Diagnosis of epilepsy confirmed by the study neurologist (KB).
English-speaking
Not pregnant

Key exclusion criteria (6 listed)

Significant cognitive impairment measured by the Montreal Cognitive Assessment (MOCA) <23.
History of other major psychiatric disorders (e.g., schizophrenia, bipolar disorder, substance use disorder (except caffeine and nicotine) or presence of unstable medical comorbidities.
Actively/imminently suicidal (QIDS item 12 score > 2 or Mini-International Neuropsychiatric Interview (MINI) Suicidality module score > 16)
Greater than 10 seizures per week during 1 month prior.
History of stroke, moderate-severe traumatic brain injury or other major neurological disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Magnetic StimulationAlso: Mag-Venture Mag-pro, TMSRepetitive 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.	Device	Low Frequency TMS Intervention

Primary outcome

Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study.
Time frame: Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up
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.
Percentage of Participants Who Complete the TMS Treatment
Time frame: 15 one-hour sessions of TMS over 3 days
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.
Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE).
Time frame: Day 1, 2, and 3 of TMS treatment
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.
Measuring Biomarker for Depression Using Dense-array EEG
Time frame: Baseline, Post-TMS, 1-month and 6-month follow-up
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.

1 secondary outcome

Changes in Depression Severity Related to the Study Interventions.
Time frame: 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up

Results and safety

Results posted to the registry on 21 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Frequency TMS Intervention	15	8

Primary outcome: Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study.

Time frame: Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up. Mean (Full Range). Unit: average number of seizures

Measure	Low Frequency TMS Intervention n = 12
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)

Population analysed: 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.

Primary outcome: Percentage of Participants Who Complete the TMS Treatment

Time frame: 15 one-hour sessions of TMS over 3 days. Count of participants. Unit: Participants

Measure	Low Frequency TMS Intervention n = 12
Value	12

Population analysed: Participants who started the TMS treatment and completed all sessions

Primary outcome: Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE).

Time frame: Day 1, 2, and 3 of TMS treatment. Number. Unit: adverse events

Measure	Low Frequency TMS Intervention n = 12
Value	1

Primary outcome: Measuring Biomarker for Depression Using Dense-array EEG

Time frame: Baseline, Post-TMS, 1-month and 6-month follow-up. Mean (Standard Deviation). Unit: frontal alpha power ratio R/L

Measure	Low Frequency TMS Intervention n = 10
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)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Frequency TMS Intervention	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42747369Bujarski K, Knight J, Song Y, Streltzov N, Castelblanco-Riveros C, Plumber J, Bursey J, Snogren S, Schommer L, Holtzheimer P. Open-label Study of Accelerated Low-Frequency TMS for Treatment-Resistant Depression in People With Epilepsy. Neuromodulation. 2026 Jun 6:S1094-7159(26)00150-9. doi: 10.1016/j.neurom.2026.05.008. Online ahead of print.
Individual participant dataSharing planned: No. Individual participant data will be de-identified and then available upon request from PI.

Related trials for Epilepsy

RecruitingObservational study
Tumor Related Epilepsy
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An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Krzysztof A. Bujarski, MD principal investigator

Associate Professor of Neurology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with Epilepsy and Depressions, Refractory, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study. (time frame: Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03105700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.