Clinical trial NCT06425029: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Official title: SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Refractory Epilepsy
Music
Keywords: music
epilepsy
responsive neurostimulation
interictal discharge
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: University of Massachusetts, Worcester
First posted: 2024-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The primary endpoint is to assess the reduction in epileptiform activity (as defined by change in normalized RNS 'long episode' detection frequency) during the 14-day stimulus presentation block for three music pieces. 1) Music piece (A) previously shown to reduce interictal epileptiform discharges (IEDs)). 2) Music piece (B) (previously shown to not reduce IEDs in the same population despite rhythmic similarities), and 3) Music piece (C) - a selection from the participant's preferred musical style that is also matched for musical characteristics.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation
* Willing to attend all study visits and complete all required study procedures
* Access to private or public wireless data service at regular intervals
* Access to personal mobile device

Exclusion Criteria:

* Documentation of a musicogenic, or auditory-triggered focal seizure semiology
* Participant is unable to reasonably participate in study tasks as determined by the investigator
* Inability to obtain informed consent from the patient or legally authorized representative

Primary outcomes:
measure: Music Intervention and its effects on epileptic activity in human brain
timeFrame: Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)
Secondary outcomes:
measure: Reduction in patient-reported seizures
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Determining duration of therapeutic effect of music intervention
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Assessment of pre- and post-intervention cognition scores (BRIEF-A)
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Assessment of pre- and post-intervention mood (DASS-21)
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Assessment of pre- and post-intervention quality of life (QOLIE-31)
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Assessment of music preferences pre- and post-intervention
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
measure: Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy
timeFrame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Brian C Fidali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quon RJ, Casey MA, Camp EJ, Meisenhelter S, Steimel SA, Song Y, Testorf ME, Leslie GA, Bujarski KA, Ettinger AB, Jobst BC. Musical components important for the Mozart K448 effect in epilepsy. Sci Rep. 2021 Sep 16;11(1):16490. doi: 10.1038/s41598-021-95922-7.
citation: Feng Y, Quon RJ, Jobst BC, Casey MA. Evoked responses to note onsets and phrase boundaries in Mozart's K448. Sci Rep. 2022 Jun 10;12(1):9632. doi: 10.1038/s41598-022-13710-3.