LFTMS: Low Frequency TMS for Depression in Epilepsy

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03105700

Collaborator

The Diamond Foundation (Other)

Enrollment

Location

Arm

55.5

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Depressions, Refractory	Device: Transcranial Magnetic Stimulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Nov 15, 2021

Actual Study Completion Date :

Nov 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Frequency TMS Intervention 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. Other Names: Mag-Venture Mag-pro TMS

Arm

Intervention/Treatment

Experimental: Low Frequency TMS Intervention

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.

Other Names:

Mag-Venture Mag-pro

TMS

Outcome Measures

Primary Outcome Measures

Change in seizure frequency [6 month follow up]
Treatment will not produce serious adverse events defined as an increase in seizure rate.
Percentage of patients who complete the study. [6 month follow up]
at least 80% of patients will complete the study protocol.
Increase in treatment-emergent adverse events [Day 3 of TMS treatment (Visit 5)]
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 at baseline and immediately post-TMS

Secondary Outcome Measures

Biomarker for Depression (dense-array EEG) [6 month follow up]
Examine the utility of dense-array EEG as a biomarker of depression and response to treatment with TMS in patients with TLE
Correlation between task performance and changes in depression severity. [6 month follow up]
Exploratory analyses will correlate baseline and change in performance on the executive function task (AX-CPT) and theory of mind (Mind in the eyes task) with changes in depression severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.