What this study is
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
What's being tested
- Experimental Intervention (Music A)
Intervention · OTHER
Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.
- Active Comparator Intervention (Music B)
Intervention · OTHER
Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.
- Active Comparator Intervention (Music C)
Intervention · OTHER
Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.
Study details
- Official title
- SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Epilepsy · Refractory Epilepsy · Music
- Enrolling
- 24 people
- Starts
- 2025-07-22
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
- CJ Hill · ContactCharles.hill6@umassmed.edu
- Natalie Erlich-Malona, MD · ContactNatalie.Erlich-Malona@umassmemorial.org
- Felicia Chu, MD · Sub-investigator
- Natalie Erlich-Malona, MD · Principal investigator
Not yet recruitingDartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
- Anastasia Kanishcheva, MPH · Contact603-650-0260Anastasia.Kanishcheva@Hitchcock.ORG
- Brian C Fidali, MD · Contact603-650-5104Brian.C.Fidali@hitchcock.org
- Brian C Fidali, MD · Principal investigator
- Barbara C Jobst, MD · Sub-investigator
Recruiting
Study team
Sponsor
Dartmouth-Hitchcock Medical Center
Study ID STUDY02002411
Principal investigator
Brian C Fidali, MD
Dartmouth-Hitchcock Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.