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

NCT06425029 | Recruiting

• 1 other identifier: STUDY02002411
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Epilepsy; Refractory Epilepsy; Music

Keywords

music; epilepsy; responsive neurostimulation; interictal discharge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Reduction in patient-reported seizures

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

• Determining duration of therapeutic effect of 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)

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

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

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

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

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

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

Study Arms (3)

Music Piece A

EXPERIMENTAL

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

Other: Experimental Intervention (Music A)

Music Piece B

ACTIVE COMPARATOR

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.

Other: Active Comparator Intervention (Music B)

Music Piece C

ACTIVE COMPARATOR

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

Other: Active Comparator Intervention (Music C)

Interventions

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.

Music Piece A

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.

Music Piece B

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.

Music Piece C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (2)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

NOT YET RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 34531410 BACKGROUND

• 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.

  PMID: 35688855 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Brian C Fidali, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Kanishcheva, MPH

CONTACT

603-650-0260; Anastasia.Kanishcheva@Hitchcock.ORG

Brian C Fidali, MD

CONTACT

603-650-5104; Brian.C.Fidali@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not be informed of their group assignment. The study team will have no knowledge of randomization sequence until all participants complete the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The primary endpoint is to assess the reduction in epileptiform activity (as defined by change in normalized RNS 'long episode' detection frequency) during the 14-day stimulus presentation block for three music pieces. 1) Music piece (A) previously shown to reduce interictal epileptiform discharges (IEDs)). 2) Music piece (B) (previously shown to not reduce IEDs in the same population despite rhythmic similarities), and 3) Music piece (C) - a selection from the participant's preferred musical style that is also matched for musical characteristics.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 22, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)