Trial Outcomes & Findings for Optimal Stimulation Parameters to Disrupt Epileptiform Activity (NCT NCT06141668)
NCT ID: NCT06141668
Last Updated: 2026-09-02
Results Overview
Spike ripple rate \~ 1 + condition + (1\|subject) This is a within-subject repeated-measures study design analyzed using a generalized linear mixed-effects model. Effect size for each arm (+/- 95% confidence interval) reported below. Treatment response was assessed using the change in spike ripple rate (SR rate) relative to each subject's baseline. For each subject, the treatment response at each stimulation frequency (1 Hz, 20 Hz, 40 Hz, 140 Hz, and 200 Hz) was calculated by subtracting the subject's baseline SR rate from the SR rate measured after stimulation at that frequency. Positive values indicate an increase in SR Rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
COMPLETED
NA
16 participants
3 hours
2026-09-02
Participant Flow
Participant milestones
| Measure |
Within Subject Multi-frequency Stimulation
Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
1 Hz Stimulation
|
11
|
|
Overall Study
20 Hz Stimulation
|
11
|
|
Overall Study
40 Hz Stimulation
|
11
|
|
Overall Study
140 Hz Stimulation
|
11
|
|
Overall Study
200Hz Stimulation
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Baseline characteristics by cohort
| Measure |
Within Subject Multi-frequency Stimulation
n=11 Participants
Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation
|
|---|---|
|
Age, Continuous
|
27.73 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 3 hoursSpike ripple rate \~ 1 + condition + (1\|subject) This is a within-subject repeated-measures study design analyzed using a generalized linear mixed-effects model. Effect size for each arm (+/- 95% confidence interval) reported below. Treatment response was assessed using the change in spike ripple rate (SR rate) relative to each subject's baseline. For each subject, the treatment response at each stimulation frequency (1 Hz, 20 Hz, 40 Hz, 140 Hz, and 200 Hz) was calculated by subtracting the subject's baseline SR rate from the SR rate measured after stimulation at that frequency. Positive values indicate an increase in SR Rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
Outcome measures
| Measure |
Within Subject Multi-frequency Stimulation
n=11 Participants
Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation
|
|---|---|
|
Spike Ripple Rate (Events Per Minute)
Baseline Stimulation
|
5.9 events per minute
Interval 3.5 to 8.3
|
|
Spike Ripple Rate (Events Per Minute)
1 Hz Stimulation
|
0.2 events per minute
Interval -0.7 to 1.1
|
|
Spike Ripple Rate (Events Per Minute)
20 Hz Stimulation
|
-0.4 events per minute
Interval -1.3 to 0.5
|
|
Spike Ripple Rate (Events Per Minute)
40 Hz Stimulation
|
-0.6 events per minute
Interval -1.5 to 0.3
|
|
Spike Ripple Rate (Events Per Minute)
140 Hz Stimulation
|
-0.8 events per minute
Interval -1.7 to 0.1
|
|
Spike Ripple Rate (Events Per Minute)
200 Hz Stimulation
|
-1.0 events per minute
Interval -2.0 to -0.1
|
SECONDARY outcome
Timeframe: 3 hoursSpike rate \~ 1 + condition + (1\|subject) This is a within-subject repeated-measures study design analyzed using a generalized linear mixed-effects model. Effect size for each arm (+/- 95% confidence interval) reported below. Treatment response was assessed using the change in spike rate relative to each subject's baseline. For each subject, the treatment response at each stimulation frequency (1 Hz, 20 Hz, 40 Hz, 140 Hz, and 200 Hz) was calculated by subtracting the subject's baseline spike rate from the spike rate measured after stimulation at that frequency. Positive values indicate an increase in spike rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
Outcome measures
| Measure |
Within Subject Multi-frequency Stimulation
n=11 Participants
Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation
|
|---|---|
|
Spike Rate (Events Per Minute)
Baseline stimulation
|
30.6 events per minute
Interval 16.2 to 45.0
|
|
Spike Rate (Events Per Minute)
1 Hz stimulation
|
-7.7 events per minute
Interval -12.4 to -3.0
|
|
Spike Rate (Events Per Minute)
20 Hz stimulation
|
-6.9 events per minute
Interval -11.6 to -2.2
|
|
Spike Rate (Events Per Minute)
40 Hz stimulation
|
-7.7 events per minute
Interval -12.4 to -3.0
|
|
Spike Rate (Events Per Minute)
140 Hz stimulation
|
-8.7 events per minute
Interval -13.4 to -4.0
|
|
Spike Rate (Events Per Minute)
200 Hz stimulation
|
-11.3 events per minute
Interval -16.0 to -6.6
|
Adverse Events
Within Subject Multi-frequency Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place