Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application (SONATA)

Dartmouth Health

Status: Enrolling

Conditions: Epilepsy; Music; Refractory Epilepsy

Treatments: Other: Active Comparator Intervention (Music B); Other: Experimental Intervention (Music A); Other: Active Comparator Intervention (Music C)

Study type: Interventional

Funder types: Other

Identifiers

NCT06425029

STUDY02002411

Details and patient eligibility

About

This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.

Full description

This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music.

It is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation.

Primary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends.

Secondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece.

This study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Music Piece A

Experimental group

Description:

Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.

Treatment:

Other: Experimental Intervention (Music A)

Music Piece B

Active Comparator group

Description:

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.

Treatment:

Other: Active Comparator Intervention (Music B)

Music Piece C

Active Comparator group

Description:

Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.

Treatment:

Other: Active Comparator Intervention (Music C)