TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Di… (NCT05241366) | Clinical Trial Compass
CompletedNot Applicable
TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder
Mexico28 participantsStarted 2022-02-14
Plain-language summary
The aim of the study is to compare the effect of Transcranial Magnetic Stimulation (TMS) versus treatment with selective serotonin reuptake inhibitors (SSRIs), in patients with diagnosis of Functional Neurological Non Epileptic Seizure Disorder (PNES).
Who can participate
Age range
18 Years – 65 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.
Inclusion criteria
. Patients with a diagnosis of PNES, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the ILAE, confirmed by video recording and/or V-EEG monitoring, and who have a monthly seizure frequency greater than 3.
. Patients who have a record at the institute with the diagnosis of PNES.
. Patients with an encephalic MRI.
. Patients who give their written consent to participate in the protocol.
. Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.
Exclusion criteria
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
1
PNES count (1/4)
Timeframe: Baseline PNES count (Starting 1 month before TMS treatment)
2
PNES count (2/4)
Timeframe: Change from Baseline PNES count (immediately after the session 12th -last session-)
3
PNES count (3/4)
Timeframe: Change from Baseline PNES count at month 1 post treatment
4
PNES count (4/4)
Timeframe: Change from Baseline PNES count at month 2 post treatment
Trial details
NCT IDNCT05241366
SponsorEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez