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NCT Number: NCT06425029

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Music Nervous System Diseases Refractory Epilepsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Intervention (Music A)

Other

Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.

Active Comparator Intervention (Music B)

Other

Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.

Active Comparator Intervention (Music C)

Other

Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.

Primary outcomes

  1. Music Intervention and its effects on epileptic activity in human brain

    Time frame: Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)

    This measure aims to determine if specific music intervention has positive effect on epileptic activity in participants with responsive neurostimulation device (RNS) implanted for drug-resistant epilepsy (DRE). The effect will be measured as a change in the number of "long episodes" or epileptic activity in a participants' brain as detected and recorded by the RNS device before and after study music interventions.

Secondary outcomes

  1. Reduction in patient-reported seizures

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will collect and assess the number of seizures reported by participants during the 4-week period before enrollment (retrospective or going back in time) and 4 1/2 months throughout the study (prospective or going forward in time).

  2. Determining duration of therapeutic effect of music intervention

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will assess the time frame (seconds, hours, days, weeks, etc.) during which the reduction of "long episodes" or epileptic activity in participants' brain, as detected by the RNS system, lasts after each music intervention.

  3. Assessment of pre- and post-intervention cognition scores (BRIEF-A)

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will measure this outcome by comparing the difference in individual scores collected via cognition questionnaire (BRIEF-A) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).

  4. Assessment of pre- and post-intervention mood (DASS-21)

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will measure this outcome by comparing the difference in individual scores collected via mood questionnaire (DASS-21) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).

  5. Assessment of pre- and post-intervention quality of life (QOLIE-31)

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will measure this outcome by comparing the difference in individual scores collected via quality-of-life questionnaire (QOLIE-31) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).

  6. Assessment of music preferences pre- and post-intervention

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will review participants' responses to study specific music questionnaire. The outcome will be measured as percentage of participants and their specific musical preferences pre- and post-intervention.

  7. Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy

    Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)

    The study team will assess participants' engagement with study interventions over the course of this study. This will be measured as a number of days each participant missed each music intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia Kanishcheva, MPH

CONTACT

[email protected]

603-650-0260

Brian C Fidali, MD

CONTACT

[email protected]

603-650-5104

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • University of Massachusetts, Worcester

Registry information

Official study title

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

Acronym: SONATA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 22, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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