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Behavioral Intervention
Recorded Music for Epilepsy
N/A
Recruiting
Led By Sarah Kelley, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up epilepsy monitoring units stay (up to day 7)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if listening to Mozart's music and other suitable songs can reduce seizures in children with epilepsy. The idea is that music might calm brain activity, helping to lower seizure frequency. Promising effects of listening to Mozart on reducing seizure frequency in individuals with epilepsy have been demonstrated over time.
Who is the study for?
This trial is for English-speaking children aged 4 to 17 with epilepsy, who are staying in Epilepsy Monitoring Units for up to a week. Children who do not speak English cannot participate.
What is being tested?
The study is testing whether listening to Mozart music or other age-appropriate music can help reduce the number of seizures and abnormal brain activity as seen on EEG in children with epilepsy.
What are the potential side effects?
Since this trial involves listening to music, there are no direct medical side effects expected. However, individual responses to music may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ epilepsy monitoring units stay (up to day 7)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~epilepsy monitoring units stay (up to day 7)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the frequency of epileptiform discharges (number of seconds with spikes)
Change in the frequency of epileptiform discharges (number of spikes)
Secondary study objectives
Change in blood pressure variability (BPV)
Change in heart rate variability (HRV)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Children with EpilepsyExperimental Treatment1 Intervention
Children (age: 4- 17 years old) will participate in this study, and they will listen to Mozart K.448 (1st movement) and instrumental age-appropriate song with 10 minutes wash out in between, each lasting up to 9 minutes in the daytime (between 1-5 pm). The music stimuli will be randomly played in 2 to 7 days during the EMU stay (average 4 days). Music will be delivered via single-use earbuds.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for epilepsy primarily include antiseizure medications, which work by stabilizing neuronal membranes and reducing excitability through various mechanisms such as enhancing inhibitory neurotransmission (e.g., GABAergic activity) or inhibiting excitatory neurotransmission (e.g., glutamatergic activity). Other treatments include neuromodulation techniques like vagus nerve stimulation and deep brain stimulation, which modulate neural circuits to prevent seizure activity.
Understanding these mechanisms is crucial for epilepsy patients as it helps in tailoring treatments that can effectively reduce seizure frequency and improve quality of life. Similar to these treatments, music therapy is being studied for its potential to modulate neural activity and reduce seizure frequency, offering a non-invasive alternative that could complement existing therapies.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,333 Previous Clinical Trials
14,875,585 Total Patients Enrolled
19 Trials studying Epilepsy
1,479 Patients Enrolled for Epilepsy
Sarah Kelley, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child aged 4-17 staying in an Epilepsy Monitoring Unit for up to 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Children with Epilepsy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.