Epilepsy, Music, Refractory Epilepsy
Conditions
Keywords
music, epilepsy, responsive neurostimulation, interictal discharge
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.
Interventions
OTHERExperimental Intervention (Music A)
Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.
OTHERActive 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.
OTHERActive 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Dartmouth College
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Music Intervention and its effects on epileptic activity in human brain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
| 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) | 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. |
| 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) | 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). |
| 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) | 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). |
| 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) | 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). |
| Assessment of music 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) | 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. |
| Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy | Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment) | 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. |
Countries
United States
Contacts
CONTACTAnastasia Kanishcheva, MPH
CONTACTBrian C Fidali, MD
PRINCIPAL_INVESTIGATORBrian C Fidali, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed