Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Recruiting · NCT06425029 · Interventional (participants receive a specific treatment) · Lead sponsor: Dartmouth-Hitchcock Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Active Comparator Intervention (Music B)Active Comparator Intervention (Music C)Experimental Intervention (Music A)
What this trial is about
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 2 US states.
- University of Massachusetts Chan Medical School - Worcester, Massachusetts, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States