Trial Outcomes & Findings for Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation (NCT NCT02339376)
NCT ID: NCT02339376
Last Updated: 2025-05-29
Results Overview
The primary outcome measure will be the self-reported frequency of seizures with loss of awareness, as recorded by participants in written seizure diaries to be provided to investigators at the end of the 12-week assessment period beginning with the initial day of intervention. This seizure frequency will be expressed as the number of days on which seizures with loss of awareness occurred per 4-week interval during the assessment period.
COMPLETED
NA
5 participants
12 weeks
2025-05-29
Participant Flow
Participant milestones
| Measure |
Group 1
Low-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 1-Hz continuous stimulation at 95% resting motor threshold, with one session each day over 10 consecutive weekdays
Low-frequency repetitive transcranial magnetic stimulation
|
Group 2
High-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 10-Hz continuous stimulation at 110% resting motor threshold, with one session each day over 10 consecutive weekdays
High-frequency repetitive transcranial magnetic stimulation
|
Group 3
Sham repetitive transcranial magnetic stimulation: use of a specially fabricated coil that provides no magnetic stimulation but has a similar appearance and creates an auditory artifact that mimics TMS
Sham repetitive transcranial magnetic stimulation
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Baseline characteristics by cohort
| Measure |
Group 1
n=5 Participants
Low-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 1-Hz continuous stimulation at 95% resting motor threshold, with one session each day over 10 consecutive weekdays
Low-frequency repetitive transcranial magnetic stimulation
|
Group 2
High-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 10-Hz continuous stimulation at 110% resting motor threshold, with one session each day over 10 consecutive weekdays
High-frequency repetitive transcranial magnetic stimulation
|
Group 3
Sham repetitive transcranial magnetic stimulation: use of a specially fabricated coil that provides no magnetic stimulation but has a similar appearance and creates an auditory artifact that mimics TMS
Sham repetitive transcranial magnetic stimulation
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
—
|
—
|
5 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
—
|
—
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
—
|
—
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
—
|
—
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
—
|
—
|
5 participants
n=7 Participants
|
|
self-reported seizure frequency
|
6.4 seizure days per 4-week interval
STANDARD_DEVIATION 5.4 • n=99 Participants
|
—
|
—
|
6.4 seizure days per 4-week interval
STANDARD_DEVIATION 5.4 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Group 1 comprised 5 participants. We were unable to recruit participants for Groups 2 and 3.
The primary outcome measure will be the self-reported frequency of seizures with loss of awareness, as recorded by participants in written seizure diaries to be provided to investigators at the end of the 12-week assessment period beginning with the initial day of intervention. This seizure frequency will be expressed as the number of days on which seizures with loss of awareness occurred per 4-week interval during the assessment period.
Outcome measures
| Measure |
Group 1
n=5 Participants
Low-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 1-Hz continuous stimulation at 95% resting motor threshold, with one session each day over 10 consecutive weekdays
Low-frequency repetitive transcranial magnetic stimulation
|
|---|---|
|
Self-reported Seizure Frequency
|
6.4 seizure days per 4 weeks
Standard Deviation 5.4
|
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bernard S. Chang, M.D.
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place