Clinical trial NCT03105700: Low Frequency TMS for Depression in Epilepsy
Official title: Safety and Feasibility of Accelerated Low-Frequency Transcranial Magnetic Stimulation for Medication-Resistant Depression in Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Depressions, Refractory
Keywords: epilepsy
depression
refractory
TMS
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: The Diamond Foundation Inc.
First posted: 2017-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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.
timeFrame: Baseline, 1-week post-treatment, 1-month post-treatment, 6-month post-treatment follow-up
measure: Percentage of Participants Who Complete the TMS Treatment
timeFrame: 15 one-hour sessions of TMS over 3 days
measure: Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE).
timeFrame: Day 1, 2, and 3 of TMS treatment
measure: Measuring Biomarker for Depression Using Dense-array EEG
timeFrame: Baseline, Post-TMS, 1-month and 6-month follow-up
Secondary outcomes:
measure: Changes in Depression Severity Related to the Study Interventions.
timeFrame: 1-week post-treatment, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Associate Professor of Neurology
name: Krzysztof A. Bujarski, MD
role: PRINCIPAL_INVESTIGATOR
References: