Transcranial Magnetic Stimulation for Epilepsy

Recruiting

Trial ID: NCT02757547

Purpose

The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS can induce long term depression in epileptogenic cortex and thus suppress cortical excitability at the epileptic focus.

Official Title

Registered Electrical Sources for Effective TMS Treatment of Epilepsy

Stanford Investigator(s)

Robert Fisher, MD, PhD
Robert Fisher, MD, PhD

The Maslah Saul, MD, Professor and Professor, by courtesy, of Neurosurgery

Eligibility


Inclusion Criteria:

   1. Failure of adequate seizure control with prior use of at least 2 anti-seizure drugs.

   2. at least one clearly identified and localizable likely seizure onset focus, as defined
   by the discharges (typically epileptiform spikes) and as identified by dEEG assessment
   through one or more routine clinical dEEG evaluations. This focus must be 2 to 3 cm
   from the head surface (to be reachable by TMS). Where multiple spike foci are present
   and meet these criteria, then the focus with either clinically relevant symptoms or
   the most spikes (or both) will be chosen as the target for treatment.

   3. two or more partial seizures, with or without secondary generalization, in the last
   month, but less than 10 seizures per day.

   4. Anti-seizure drug regimen has remained unchanged for the month before study entry, and
   there is reasonable likelihood of stability for the duration of the study, with the
   exception of allowing short-term rescue medications, such as lorazepam.

   5. a history of epilepsy for at least 2 years.

   6. age of 22 years and older.

Exclusion Criteria:

   1. If of childbearing potential, the patient must agree to use an effective method of
   birth control during the study and cease participation if pregnant.

   2. Nursing mothers are excluded.

   3. A history or condition of progressive brain disorders, serious systemic diseases,
   symptomatic cerebrovascular disease, cardiac disease, or alcohol abuse. Special
   conditions, for example, non-malignant brain tumors and vascular malformations, can be
   considered for entry on a case-by-case basis. Patients are not excluded on the basis
   of previous psychiatric hospitalizations or suicide attempts.

   4. A history or condition of (generalized) status epilepticus or psychogenic seizures.

   5. Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implantation in the
   body (other than the teeth) including neurostimulators, cochlear implants, and
   implanted medication pumps.

   6. Previous surgery involving opening the skull.

   7. Unable to express presence of pain or discomfort.

Intervention(s):

device: Transcranial magnetic stimulation - placebo arm

device: Transcranial magnetic stimulation - active arm

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305