Low Frequency TMS for Depression in Epilepsy

NCT03105700 | Completed Results FDA Device

• 1 other identifier: D16150
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. Patients will have in-person follow up visits after one month and again after six months.

Conditions

Epilepsy; Depressions, Refractory

Keywords

epilepsy; depression; refractory; TMS

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, Post-TMS, 1-month and 6-month follow-up

Secondary Outcomes (1)

• Changes in Depression Severity Related to the Study Interventions.

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

Study Arms (1)

Low Frequency TMS Intervention

EXPERIMENTAL

Patients will receive low-frequency TMS on an accelerated schedule over three consecutive days.

Device: Transcranial Magnetic Stimulation

Interventions

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.

Also known as: Mag-Venture Mag-pro, TMS

Low Frequency TMS Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• The Diamond Foundation Inc.: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy; Depressive Disorder, Treatment-Resistant; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Krzysztof Bujarski, MD
• Organization: Dartmouth Hitchcock Medical Center

krzysztof.a.bujarski@hitchcock.org

6036505000

Study Officials

• Krzysztof A. Bujarski, MD

  Associate Professor of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 10, 2017
• Study Start: April 1, 2017
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)