One-of-a-kind self‑administered web music therapy for epilepsy
SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
This test sees if daily listening to specific music through a web app can reduce epileptic brain activity in adults with medication‑resistant focal epilepsy who have an RNS implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 2 sites (Worcester, Massachusetts and 1 other locations) |
| Trial ID | NCT06425029 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blinded, placebo‑controlled study has participants listen to one of three music tracks at home using a web app and compares effects across treatment blocks. Participants are adults with drug‑resistant focal epilepsy already implanted with a NeuroPace RNS system, which provides continuous electrocorticographic recordings used as the primary outcome measure. The primary outcome is reduction in RNS-detected long episode events during and after the music intervention; secondary outcomes include patient‑reported mood, quality of life, and cognitive measures. The study is self‑administered in a naturalistic home environment and uses active comparator tracks to mask allocation.
Who should consider this trial
Good fit: Adults with medication‑refractory focal epilepsy who have had an RNS implant for at least six months, are on a stable RNS regimen, can use a mobile device and wireless data, and can attend study visits are ideal candidates.
Not a fit: Patients without an RNS implant, those with musicogenic or auditory‑triggered seizures, or those unable to use a mobile device or consent are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a simple daily music intervention could lower epileptiform activity and improve mood and quality of life without changing medications or surgery.
How similar studies have performed: Prior electrophysiological studies have reported reductions in epileptiform discharges and seizures with specific music, but this is among the first randomized, self‑administered home studies using RNS recordings to test daily music over weeks.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Worcester, Massachusetts and 1 other locations
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (Not_yet_recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Brian C Fidali, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Anastasia Kanishcheva, MPH
- Email: Anastasia.Kanishcheva@Hitchcock.ORG
- Phone: 603-650-0260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.