TerminatedNot Applicable

Repeated TMS at Low Frequencies to Reduce Seizure Occurrence

Stopped: Low Recruitment

United States2 participantsStarted 2016-02-19

Plain-language summary

Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with the intent to reduce the occurrence of seizures over time (long-term protocol). Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module. Up to 100 individuals 18 to 80 years with epilepsy will be enrolled. In addition, a short-term protocol has been added to test whether LF-rTMS can reduce or suppress status epilepticus in medically refractory participants.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Long-term protocol: Inclusion Criteria: * Experience ≥ 3 seizures/month in the month prior to starting study (any type of seizure will count) * No status epilepticus in the last 12 months * No change in medication in last 30 days Exclusion Criteria: * Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant) * Presence of intracranial metal (e.g., aneurysm clip) * Unable to cooperate with non-sedated, navigated TMS testing Short-term protocol: Inclusion Criteria: * Epilepsia partialis continua or status epilepticus * At least 2 medications failed * At least 24 hours of acute phase Exclusion Criteria: * Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant) * Presence of intracranial metal (e.g., aneurysm clip)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Weekly Seizure Frequency

Timeframe: 6 and 7 weeks post rTMS treatment

Scalp EEG: Number of Interictal Epileptiform Discharges

Timeframe: From start of intervention through 5 days of treatment

Seizure Duration Proxy for Seizure Severity

Timeframe: 6-7-weeks post rTMS treatment

Trial details

NCT IDNCT03154307

SponsorBaptist Health South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-23

Results submitted2022-11-09

View on ClinicalTrials.gov More Epilepsy trials