Low Frequency TMS for Depression in Epilepsy



Status:Recruiting
Conditions:Depression, Depression, Neurology, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:6/23/2018
Start Date:April 1, 2017
End Date:April 2020
Contact:Harold H Yang, B.A.
Email:Harold.H.Yang@hitchcock.org
Phone:603-650-0260

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

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 focal 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.

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 enroll 20 patients with focal 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.

Inclusion Criteria:

- Age 18 or older

- Able and willing to provide informed consent.

- Diagnosis of focal epilepsy 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 > 6)

- 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.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Krzysztof A Bujarski, MD
Phone: 603-650-4506
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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