Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425029
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-09
Brief Title:
Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
SONATA Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONATA
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None