Nonepileptic SeizuresNCT02796924
Treating Non-epileptic Seizures Using Magnetic Brain Stimulation
A study testing MagStim Rapid2 Transcranial Magnetic Simulation in people with Nonepileptic Seizures, run by University of Manitoba.
Trial summary
The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonepileptic Seizures
- What is being tested?
- MagStim Rapid2 Transcranial Magnetic Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Psychogenic Non-Epileptic Seizures
Who cannot join
- Evidence of previous or comorbid epileptic seizures
- Major comorbid neurological diseases
- Currently taking medications that are known to reduce seizure-threshold
- Currently pregnant
About this study
Official title: The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures
The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.
Read the detailed description
This study is an open label pilot study that aims to recruit 15 individuals with diagnosed PNES to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) to decreasing the frequency of psychogenic non-epileptic seizure (PNES) episodes. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to active neurons in a specified target location of the brain.
Electronic as well as paper-and-pencil questionnaires will be used to asses patient's psychiatric symptoms and functional impairment both before and after treatment to monitor symptom-changes.Treatment will consist of daily sessions of high frequency (20 Hz) rTMS applied over the right temporoparietal junction (TPJ) of the cerebral cortex. Patients will receive two sessions per day for 15 consecutive weekdays. Each session will take approximately 20 minutes to complete.
Results of the questionnaires will be analyzed to determine the effect of the treatment on PNES episodes and functional impairment. As a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.
- Conditions
- Nonepileptic Seizures
- Being tested
- MagStim Rapid2 Transcranial Magnetic Simulation
- Keywords
- Psychogenic Non-Epileptic Seizure, Transcranial Magnetic Stimulation, Brain Stimulation
- Medical subject headings
- Seizures, Psychogenic Nonepileptic Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagStim Rapid2 Transcranial Magnetic SimulationDevice
A non-invasive method of brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine. Receives: Device: MagStim Rapid2 Transcranial Magnetic Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Weekly Psychogenic Non-epileptic Seizure-events
Number of weekly seizure-events recorded using seizure logs.
Measured: One week and three months post-rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonepileptic SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandana Modirrousta, MD PhD FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796924
- Sponsor's protocol ID
- B2016:039
- Status last verified
- Mar 2020
- First submitted
- 3 Jun 2016
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures
- ClinicalTrials.gov ID
- NCT02796924
- Acronym / sponsor ID
- B2016:039
- Conditions
- Nonepileptic Seizures
- Keywords
- Psychogenic Non-Epileptic Seizure, Transcranial Magnetic Stimulation, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.
Detailed description
This study is an open label pilot study that aims to recruit 15 individuals with diagnosed PNES to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) to decreasing the frequency of psychogenic non-epileptic seizure (PNES) episodes. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to active neurons in a specified target location of the brain.
Electronic as well as paper-and-pencil questionnaires will be used to asses patient's psychiatric symptoms and functional impairment both before and after treatment to monitor symptom-changes.Treatment will consist of daily sessions of high frequency (20 Hz) rTMS applied over the right temporoparietal junction (TPJ) of the cerebral cortex. Patients will receive two sessions per day for 15 consecutive weekdays. Each session will take approximately 20 minutes to complete.
Results of the questionnaires will be analyzed to determine the effect of the treatment on PNES episodes and functional impairment. As a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: MagStim Rapid2 Transcranial Magnetic Simulation30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed Psychogenic Non-Epileptic Seizures
Key exclusion criteria (4 listed)
- Evidence of previous or comorbid epileptic seizures
- Major comorbid neurological diseases
- Currently taking medications that are known to reduce seizure-threshold
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagStim Rapid2 Transcranial Magnetic SimulationA non-invasive method of brain stimulation | Device | Patients |
Primary outcome
Number of Weekly Psychogenic Non-epileptic Seizure-events
Time frame: One week and three months post-rTMS treatment
Number of weekly seizure-events recorded using seizure logs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nonepileptic Seizures
RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
RecruitingPhase 1/2
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
Non Epileptic Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandana Modirrousta, MD PhD FRCPC principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing MagStim Rapid2 Transcranial Magnetic Simulation in people with Nonepileptic Seizures, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Weekly Psychogenic Non-epileptic Seizure-events (time frame: One week and three months post-rTMS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.