Repeated TMS at Low Frequencies to Reduce Seizure Occurrence
Stopped early · Not applicable · Has a placebo group
Conditions studied: Epilepsy, Status Epilepticus, Epilepsia Partialis Continua, Epilepsia Partialis Continua, Refractory (Medically)
In brief
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.
Key facts
- Study ID
- NCT03154307
- Run by
- Baptist Health South Florida
- People needed
- 2
- Starts
- 2016-02-19
- Expected to finish
- 2019-08-23
- Last updated by the study team
- 2023-06-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Baptist Hospital of Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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