RECRUITINGINTERVENTIONAL
Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
About This Trial
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form from the patient or legally authorized representative
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Experimental Intervention (Music A)
Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.
OTHER
Active Comparator Intervention (Music B)
Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.
OTHER
Active Comparator Intervention (Music C)
Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.
Locations (2)
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States