Dartmouth-Hitchcock Medical Center
Brian Fidali, MD
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Epilepsy
Refractory Epilepsy
Music
Experimental Intervention (Music A)
Active Comparator Intervention (Music B)
Active Comparator Intervention (Music C)
NA
This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music. It is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation. Primary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends. Secondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece. This study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 24 participants |
| Masking : | DOUBLE |
| Masking Description : | Participants will not be informed of their group assignment. The study team will have no knowledge of randomization sequence until all participants complete the study. |
| Primary Purpose : | BASIC_SCIENCE |
| Official Title : | SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application |
| Actual Study Start Date : | 2024-12-01 |
| Estimated Primary Completion Date : | 2025-12-01 |
| Estimated Study Completion Date : | 2026-03-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Not yet recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756