## Protocol Section
### Identification Module
**NCT ID:** NCT06425029

**Acronym:** SONATA

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

**Official Title:** SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

#### Organization Study ID Info
**ID:** STUDY02002411
#### Organization
**Class:** OTHER
**Full Name:** Dartmouth-Hitchcock Medical Center
### Status Module
#### Completion Date
**Date:** 2026-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Dartmouth College

**Class:** OTHER

**Name:** University of Massachusetts, Worcester

#### Lead Sponsor

**Class:** OTHER

**Name:** Dartmouth-Hitchcock Medical Center

#### Responsible Party

**Investigator Affiliation:** Dartmouth-Hitchcock Medical Center

**Investigator Full Name:** Brian Fidali, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Epilepsy

- Refractory Epilepsy

- Music

**Keywords:**

- music

- epilepsy

- responsive neurostimulation

- interictal discharge

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention 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 Info

**Masking:** DOUBLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Experimental Intervention (Music A)

**Label:** Music Piece A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Active Comparator Intervention (Music B)

**Label:** Music Piece B

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: Active Comparator Intervention (Music C)

**Label:** Music Piece C

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music Piece A

**Description:** Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.

**Name:** Experimental Intervention (Music A)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Music Piece B

**Description:** Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.

**Name:** Active Comparator Intervention (Music B)

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Music Piece C

**Description:** Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.

**Name:** Active Comparator Intervention (Music C)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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)

#### Secondary Outcomes

**Description:** 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).

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

**Description:** 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).

**Measure:** 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)

**Description:** 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).

**Measure:** 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)

**Description:** 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).

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Anastasia.Kanishcheva@Hitchcock.ORG

**Name:** Anastasia Kanishcheva, MPH

**Phone:** 603-650-0260

**Role:** CONTACT

**Contact 2:**

**Email:** Brian.C.Fidali@hitchcock.org

**Name:** Brian C Fidali, MD

**Phone:** 603-650-5104

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Worcester

**Contacts:**

***Contact 1:***

- **Email:** Charles.hill6@umassmed.edu

- **Name:** CJ Hill

- **Role:** CONTACT

***Contact 2:***

- **Email:** Natalie.Erlich-Malona@umassmemorial.org

- **Name:** Natalie Erlich-Malona, MD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Felicia Chu, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Natalie Erlich-Malona, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Massachusetts Chan Medical School

**State:** Massachusetts

**Zip:** 01655

**Location 2:**

**City:** Lebanon

**Contacts:**

***Contact 1:***

- **Email:** Anastasia.Kanishcheva@Hitchcock.ORG

- **Name:** Anastasia Kanishcheva, MPH

- **Phone:** 603-650-0260

- **Role:** CONTACT

***Contact 2:***

- **Email:** Brian.C.Fidali@hitchcock.org

- **Name:** Brian C Fidali, MD

- **Phone:** 603-650-5104

- **Role:** CONTACT

***Contact 3:***

- **Name:** Brian C Fidali, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Barbara C Jobst, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Dartmouth-Hitchcock Medical Center

**State:** New Hampshire

**Zip:** 03756

#### Overall Officials

**Official 1:**

**Affiliation:** Dartmouth-Hitchcock Medical Center

**Name:** Brian C Fidali, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 34531410

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: HIGH

- As Found: Epilepsy

- ID: M369

- Name: Drug Resistant Epilepsy

- Relevance: HIGH

- As Found: Refractory Epilepsy

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004827

- Term: Epilepsy

- ID: D000069279

- Term: Drug Resistant Epilepsy

### Intervention Browse Module - Browse Branches

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M250768

- Name: Zaleplon

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
