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Behavioural Intervention
Music Therapy for Epilepsy (SONATA Trial)
N/A
Waitlist Available
Led By Brian C Fidali, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Awards & highlights
Summary
This trial is going to test a new type of hearing intervention at home.
Who is the study for?
This trial is for adults with hard-to-treat focal epilepsy who have had an RNS device implanted at least six months ago and are on a stable RNS treatment. Participants must be able to attend study visits, complete procedures, and have regular access to Wi-Fi and a personal mobile device.
What is being tested?
The study tests three different music interventions (Music A, B, C) delivered through a web app for epilepsy therapy. It's designed to see if any of the music types can help manage seizures better than usual care in a home setting.
What are the potential side effects?
Since this trial involves listening to music as an intervention, there may not be direct side effects like those seen with medications or invasive treatments. However, participants should report any discomfort or unusual reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Music Intervention and its effects on epileptic activity in human brain
Secondary outcome measures
Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy
Assessment of music preferences pre- and post-intervention
Assessment of pre- and post-intervention cognition scores (BRIEF-A)
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Music Piece AExperimental Treatment1 Intervention
Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.
Group II: Music Piece BActive Control1 Intervention
Participants will be asked to listen to a musical except very similar to the experimental stimuli that has not been shown to have a positive effect on epileptic activity.
Group III: Music Piece CActive Control1 Intervention
Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
530 Previous Clinical Trials
2,544,910 Total Patients Enrolled
13 Trials studying Epilepsy
1,160 Patients Enrolled for Epilepsy
Dartmouth CollegeOTHER
84 Previous Clinical Trials
1,419,439 Total Patients Enrolled
1 Trials studying Epilepsy
175 Patients Enrolled for Epilepsy
University of Massachusetts, WorcesterOTHER
350 Previous Clinical Trials
989,806 Total Patients Enrolled
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