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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Music Intervention and its effects on epileptic activity in human brain

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

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