EpilepsySONATANCT06425029
Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
A study testing Experimental Intervention (Music A), Active Comparator Intervention (Music B) and Active Comparator Intervention (Music C) in people with Epilepsy and Refractory Epilepsy, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Refractory Epilepsy, Music
- What is being tested?
- Experimental Intervention (Music A), Active Comparator Intervention (Music B) and Active Comparator Intervention (Music C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Anastasia Kanishcheva, MPH, 603-650-0260, Anastasia.Kanishcheva@Hitchcock.ORG
Brian C Fidali, MD, 603-650-5104, Brian.C.Fidali@hitchcock.org
- Not yet recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
CJ Hill, Charles.hill6@umassmed.edu
Natalie Erlich-Malona, MD, Natalie.Erlich-Malona@umassmemorial.org
About this study
Official title: SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Read the detailed 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.
- Conditions
- Epilepsy, Refractory Epilepsy, Music
- Being tested
- Experimental Intervention (Music A), Active Comparator Intervention (Music B), Active Comparator Intervention (Music C)
- Keywords
- music, epilepsy, responsive neurostimulation, interictal discharge
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Active Comparator Intervention (Music C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)
Secondary outcomes (7)
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).
Measured: 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
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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 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.
Measured: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
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.
Measured: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start22 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Brian Fidali, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Brian C Fidali, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425029
- Sponsor's protocol ID
- STUDY02002411
- Acronym
- SONATA
- Status last verified
- May 2026
- First submitted
- 9 May 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
Publications
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.
PubMed 34531410Feng 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.
PubMed 35688855
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
- ClinicalTrials.gov ID
- NCT06425029
- Acronym / sponsor ID
- SONATA / STUDY02002411
- Conditions
- Epilepsy, Refractory Epilepsy, Music
- Keywords
- music, epilepsy, responsive neurostimulation, interictal discharge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College, University of Massachusetts, Worcester
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Piece A | Experimental | Other: Experimental Intervention (Music A)Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain. |
| Music Piece B | Active comparator | Other: Active Comparator Intervention (Music 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. |
| Music Piece C | Active comparator | Other: Active Comparator Intervention (Music 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Music Piece A |
| 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. | Other | Music Piece B |
| 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. | Other | Music Piece C |
Primary outcome
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)
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.
7 secondary outcomes
Reduction in patient-reported seizures
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 music preferences pre- and post-intervention
Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy
Time frame: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 34531410Quon 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.
- Background: PubMed 35688855Feng 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.
- Individual participant dataSharing planned: No. The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian C Fidali, MD principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention (Music A), Active Comparator Intervention (Music B) and Active Comparator Intervention (Music C) in people with Epilepsy and Refractory Epilepsy, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Kanishcheva, MPH (603-650-0260, Anastasia.Kanishcheva@Hitchcock.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.