Low Frequency TMS for Depression in Epilepsy

NCT ID: NCT03105700

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-11-15

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Frequency TMS Intervention

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

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Mag-Venture Mag-pro; TMS

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Diamond Foundation Inc.

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Bujarski

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krzysztof A. Bujarski, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Neurology

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D16150

Identifier Type: -

Identifier Source: org_study_id