Transcranial Magnetic Stimulation for Epilepsy

NCT02757547 | Terminated Results DMC

• 1 other identifier: IDEG150216
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Suppression of Seizure Frequency

  The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.

  Placebo compared to Active

Study Arms (2)

Transcranial magnetic stimulation - Placebo Arm

PLACEBO COMPARATOR

A placebo TMS coil is used.

Device: Transcranial magnetic stimulation - Placebo Arm

Transcranial magnetic stimulation - Active Arm

ACTIVE COMPARATOR

An active TMS coil is used.

Device: Transcranial magnetic stimulation - Active Arm

Interventions

Transcranial magnetic stimulation - Placebo Arm DEVICE

Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.

Transcranial magnetic stimulation - Placebo Arm

Transcranial magnetic stimulation - Active Arm DEVICE

Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.

Also known as: STM9000 Transcranial Magnetic Stimulator

Transcranial magnetic stimulation - Active Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failure of adequate seizure control with prior use of at least 2 anti-seizure drugs.
• 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.
• two or more partial seizures, with or without secondary generalization, in the last month, but less than 10 seizures per day.
• 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.
• a history of epilepsy for at least 2 years.
• age of 22 years and older.

You may not qualify if:

• If of childbearing potential, the patient must agree to use an effective method of birth control during the study and cease participation if pregnant.
• Nursing mothers are excluded.
• 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.
• A history or condition of (generalized) status epilepticus or psychogenic seizures.
• 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.
• Previous surgery involving opening the skull.
• Unable to express presence of pain or discomfort.

Sponsors & Collaborators

• Electrical Geodesics, Inc.: lead
• Stanford University: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Pat Olsen
• Organization: Philips

pat.olsen@philips.com

(303) 475-3417

Study Officials

• Robert S Fisher, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 2, 2016
• Study Start: September 1, 2015
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: July 23, 2020
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share