Refractory Epilepsy
Conditions
Brief summary
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We compared the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.
Interventions
OTHERNeurostimulation
Electrical stimulation
Sponsors
Massachusetts General Hospital
Boston University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation. * Consented for stimulation experiment.
Exclusion criteria
* Baseline spike ripple rate \< 0.5/min. * Did not complete 3 hours of stimulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spike Ripple Rate (Events Per Minute) | 3 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spike Rate (Events Per Minute) | 3 hours | Spike 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine Chu, MD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.73 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed