Nonepileptic Seizures
Conditions
Keywords
Psychogenic Non-Epileptic Seizure, Transcranial Magnetic Stimulation, Brain Stimulation
Brief 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.
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.
Interventions
A non-invasive method of brain stimulation
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed Psychogenic Non-Epileptic Seizures
Exclusion criteria
* Evidence of previous or comorbid epileptic seizures * Major comorbid neurological diseases * Currently taking medications that are known to reduce seizure-threshold * Currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Weekly Psychogenic Non-epileptic Seizure-events | One week and three months post-rTMS treatment | Number of weekly seizure-events recorded using seizure logs. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients 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.
MagStim Rapid2 Transcranial Magnetic Simulation: A non-invasive method of brain stimulation | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 8 |
| Number of weekly seizure-events | 8.1 events STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment Canada | 10 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
| Sex/Gender, Customized Gender Female | 7 Participants |
| Sex/Gender, Customized Gender Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Weekly Psychogenic Non-epileptic Seizure-events
Number of weekly seizure-events recorded using seizure logs.
Time frame: One week and three months post-rTMS treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients | Number of Weekly Psychogenic Non-epileptic Seizure-events | One week post-rTMS | 6.9 events | Standard Deviation 15.5 |
| Patients | Number of Weekly Psychogenic Non-epileptic Seizure-events | Three months post-rTMS | 5.3 events | Standard Deviation 9.6 |