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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06425029
Other study ID # STUDY02002411
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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