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

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

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 treatment

Number of weekly seizure-events recorded using seizure logs.

Outcome measures

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

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

Dr. Mandana Modirrousta

University of Manitoba

Phone: 2042372303

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place