Recruiting

Auditory Intervention

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06425029

Conditions

Epilepsy

Refractory Epilepsy

Music

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental Intervention (Music A)

Active Comparator Intervention (Music B)

Active Comparator Intervention (Music C)

Study Details

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

Study ID

NCT06425029

Start date

Jul 22, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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: 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.

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Anastasia Kanishcheva, MPH

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

Brian C Fidali, MD

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

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Anastasia Kanishcheva, MPH

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

Brian C Fidali, MD

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

Principal Investigator:

Brian C Fidali, MD

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • music
  • epilepsy
  • responsive neurostimulation
  • interictal discharge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-05-20.