Trial Outcomes & Findings for Transcranial Magnetic Stimulation for BECTS (NCT NCT04325282)
NCT ID: NCT04325282
Last Updated: 2025-09-04
Results Overview
We will count the number of IEDs/minute before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in IEDs induced by the active and sham stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Results posted on
2025-09-04
Participant Flow
This study enrolled participants with Self Limited Epilepsy with Centrotemporal Spikes (SeLECTS), formerly known as Benign Epilepsy with Centrotemporal Spikes (BECTS).
Participant milestones
| Measure |
Children With SeLECTS - Active, Then Sham rTMS
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham, Then Active rTMS
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
11
|
11
|
|
First Intervention (1 Day)
COMPLETED
|
11
|
10
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
1
|
|
Washout Period (1 Week)
STARTED
|
11
|
10
|
|
Washout Period (1 Week)
COMPLETED
|
11
|
10
|
|
Washout Period (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
11
|
10
|
|
Second Intervention (1 Day)
COMPLETED
|
11
|
9
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Children With SeLECTS - Active, Then Sham rTMS
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham, Then Active rTMS
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
|---|---|---|
|
First Intervention (1 Day)
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention (1 Day)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Transcranial Magnetic Stimulation for BECTS
Baseline characteristics by cohort
| Measure |
Children With SeLECTS - Active, Then Sham rTMS
n=11 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham, Then Active rTMS
n=8 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
9.8 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)Population: Participants with Analyzable Data (Remained awake for both active \& sham rTMS sessions)
We will count the number of IEDs/minute before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in IEDs induced by the active and sham stimulation.
Outcome measures
| Measure |
Children With SeLECTS - Active rTMS
n=19 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham rTMS
n=19 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
|---|---|---|
|
Interictal Epileptiform Discharge (IED) Frequency
Before rTMS
|
0 IEDs per 5 minutes
Interval 0.0 to 20.5
|
0 IEDs per 5 minutes
Interval 0.0 to 18.0
|
|
Interictal Epileptiform Discharge (IED) Frequency
After rTMS
|
0 IEDs per 5 minutes
Interval 0.0 to 12.0
|
0 IEDs per 5 minutes
Interval 0.0 to 18.5
|
|
Interictal Epileptiform Discharge (IED) Frequency
Change from pre-rTMS to post-rTMS
|
0 IEDs per 5 minutes
Interval -6.5 to 0.0
|
0 IEDs per 5 minutes
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)Population: Participants with Analyzable Data (Remained awake for both active \& sham rTMS sessions)
We will measure brain connectivity before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in connectivity induced by the active and sham stimulation. In particular, we will look at how connectivity changes between the motor cortex and language regions of the brain. We chose 3 regions of interest per hemisphere (-F: Frontal, -M: Motor, -T: Temporal). rTMS was applied to the hemisphere with more spikes on clinical EEG, and hence all regions were further qualified as being ipsilateral (i-) or contralateral (c-) to rTMS application. Connectivity is measured in the weighted Phase Lag Index (wPLI) in the beta-frequency band, a phase-based connectivity measure which runs from a theoretical minimum of 0 (no connectivity) to 1 (complete connectivity).
Outcome measures
| Measure |
Children With SeLECTS - Active rTMS
n=19 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham rTMS
n=19 Participants
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
|---|---|---|
|
Change in Brain Connectivity
Change in cF-iT Connectivity
|
-0.025147033 wPLI
Interval -0.06736053235 to -0.009095556347
|
0.001240549 wPLI
Interval -0.01674470333 to 0.03546101011
|
|
Change in Brain Connectivity
Change in cM-iT Connectivity
|
-0.026464821 wPLI
Interval -0.09033280758 to -0.004439810119
|
0.015413055 wPLI
Interval -0.009845339466 to 0.05680533952
|
|
Change in Brain Connectivity
Change in iF-cM Connectivity
|
-0.038566551 wPLI
Interval -0.07507071808 to -0.000831546384
|
0.009032342 wPLI
Interval -0.01706492182 to 0.02160196731
|
|
Change in Brain Connectivity
Change in iF-iT Connectivity
|
-0.031871907 wPLI
Interval -0.06020716415 to -0.008456458479
|
0.005724761 wPLI
Interval -0.01917787091 to 0.03179566288
|
|
Change in Brain Connectivity
Change in iF-cF Connectivity
|
-0.017828074 wPLI
Interval -0.131733617 to -0.005389702698
|
0.004773205 wPLI
Interval -0.01693847284 to 0.04093271291
|
|
Change in Brain Connectivity
Change in iM-cT Connectivity
|
-0.016437136 wPLI
Interval -0.05883184645 to 0.009583756
|
0.010533673 wPLI
Interval -0.01520736144 to 0.02572202471
|
|
Change in Brain Connectivity
Change in iF-cT Connectivity
|
-0.017946561 wPLI
Interval -0.05996626405 to 0.001548810394
|
0.008023921 wPLI
Interval -0.005516234384 to 0.02195947435
|
|
Change in Brain Connectivity
Change in iF-iM Connectivity
|
-0.028419447 wPLI
Interval -0.06790541051 to -0.01930392446
|
0.011937066 wPLI
Interval -0.01998846337 to 0.03538472482
|
|
Change in Brain Connectivity
Change in iT-cT Connectivity
|
-0.041984947 wPLI
Interval -0.08226344292 to 0.00820188987
|
-0.000655525 wPLI
Interval -0.009649517287 to 0.0352091797
|
|
Change in Brain Connectivity
Change in cF-cT Connectivity
|
-0.022140561 wPLI
Interval -0.04754855866 to 0.006893751688
|
0.006909577 wPLI
Interval -0.01526276726 to 0.03540581226
|
|
Change in Brain Connectivity
Change in cF-cM Connectivity
|
-0.011221254 wPLI
Interval -0.0543134682 to 0.006043824425
|
0.009773165 wPLI
Interval -0.009669095958 to 0.03596951991
|
|
Change in Brain Connectivity
Change in cF-iM Connectivity
|
-0.031668097 wPLI
Interval -0.05419498148 to 0.003974133567
|
0.01966644 wPLI
Interval -0.009877540375 to 0.0318713625
|
|
Change in Brain Connectivity
Change in iM-iT Connectivity
|
-0.030898043 wPLI
Interval -0.05097858412 to -0.003586219461
|
0.002850137 wPLI
Interval -0.004130106912 to 0.02728766311
|
|
Change in Brain Connectivity
Change in cM-cT Connectivity
|
-0.029060306 wPLI
Interval -0.05558707448 to 0.01102180261
|
-0.00727134 wPLI
Interval -0.0244931598 to 0.02049569394
|
|
Change in Brain Connectivity
Change in iM-cM Connectivity
|
-0.032771045 wPLI
Interval -0.07116425937 to 0.004104307197
|
0.004707047 wPLI
Interval -0.02741234695 to 0.02510245297
|
Adverse Events
Children With SeLECTS - Active rTMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Children With SeLECTS - Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Children With SeLECTS - Active rTMS
n=19 participants at risk
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
Children With SeLECTS - Sham rTMS
n=19 participants at risk
Children will receive sham and active (1 Hz) rTMS on 2 separate study visits separated by at least 1 week.
|
|---|---|---|
|
Nervous system disorders
Head pain during stimulation
|
10.5%
2/19 • 1 week
|
0.00%
0/19 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place