Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Experimental Intervention (Music A)
Other interventionParticipants 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 interventionParticipants 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 interventionParticipants will be asked to listen to music C on their personal device daily, at a time most convenient for them.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Music Piece AExperimental treatment 1 intervention
Group B: Music Piece BActive comparator 1 intervention
Group C: Music Piece CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)Secondary outcomes
1
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).
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)2
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.
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)3
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).
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)4
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).
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
University of Massachusetts, Worcester
Collaborator
Source ClinicalTrials.gov