Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
NCT ID: NCT06425029
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-07-22
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Music Piece A
Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.
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.
Music Piece B
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.
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.
Music Piece C
Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Dartmouth College
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Brian Fidali, MD
Principal Investigator
Principal Investigators
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Brian C Fidali, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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STUDY02002411
Identifier Type: -
Identifier Source: org_study_id
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