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

Epilepsy Clinical Trial

— SONATA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425029
• Other study ID #: STUDY02002411
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Anastasia Kanishcheva, MPH
• Phone: 603-650-0260
• Email: Anastasia.Kanishcheva[@]Hitchcock.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Music
• Refractory Epilepsy

Intervention

Other:
• Experimental Intervention (Music A)
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)
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)
Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (2)

Feng Y, Quon RJ, Jobst BC, Casey MA. Evoked responses to note onsets and phrase boundaries in Mozart's K448. Sci Rep. 2022 Jun 10;12(1):9632. doi: 10.1038/s41598-022-13710-3. — View Citation

Quon RJ, Casey MA, Camp EJ, Meisenhelter S, Steimel SA, Song Y, Testorf ME, Leslie GA, Bujarski KA, Ettinger AB, Jobst BC. Musical components important for the Mozart K448 effect in epilepsy. Sci Rep. 2021 Sep 16;11(1):16490. doi: 10.1038/s41598-021-95922-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Music Intervention and its effects on epileptic activity in human brain	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.	Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)
Secondary	Reduction in patient-reported seizures	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).	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Determining duration of therapeutic effect of music intervention	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.	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Assessment of pre- and post-intervention cognition scores (BRIEF-A)	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).	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Assessment of pre- and post-intervention mood (DASS-21)	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).	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Assessment of pre- and post-intervention quality of life (QOLIE-31)	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).	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Assessment of music preferences pre- and post-intervention	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.	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Secondary	Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy	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.	Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)