Trial Outcomes & Findings for Treating Non-epileptic Seizures Using Magnetic Brain Stimulation (NCT NCT02796924)
NCT ID: NCT02796924
Last Updated: 2020-09-30
Results Overview
Number of weekly seizure-events recorded using seizure logs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
One week and three months post-rTMS treatment
Results posted on
2020-09-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Non-epileptic Seizures Using Magnetic Brain Stimulation
Baseline characteristics by cohort
| Measure |
Patients
n=10 Participants
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
|
|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
7 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=5 Participants
|
|
Number of weekly seizure-events
|
8.1 events
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: One week and three months post-rTMS treatmentNumber of weekly seizure-events recorded using seizure logs.
Outcome measures
| Measure |
Patients
n=10 Participants
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
|
|---|---|
|
Number of Weekly Psychogenic Non-epileptic Seizure-events
One week post-rTMS
|
6.9 events
Standard Deviation 15.5
|
|
Number of Weekly Psychogenic Non-epileptic Seizure-events
Three months post-rTMS
|
5.3 events
Standard Deviation 9.6
|
Adverse Events
Patients
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients
n=10 participants at risk
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
|
|---|---|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 6 • 4 months
|
|
Nervous system disorders
Fatigue
|
40.0%
4/10 • Number of events 4 • 4 months
|
|
Nervous system disorders
Vivid dreams
|
40.0%
4/10 • Number of events 4 • 4 months
|
|
Nervous system disorders
Pain
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Nervous system disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place