Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Non-English speaking
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the music and epilepsy trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Music Stimuli, Mozart Music Therapy, Music Stimuli, Auditory Stimulation for epilepsy?
Research shows that listening to Mozart's music, particularly the Sonata for Two Pianos in D major, K.448, can reduce epileptiform discharges (abnormal brain activity) in people with epilepsy. Studies have found significant decreases in these discharges and improvements in seizure control and behavior in children with epilepsy when exposed to Mozart's compositions.
12345Is listening to recorded music, like Mozart's compositions, safe for people with epilepsy?
Research on using Mozart's music for epilepsy shows it can reduce seizure-related brain activity without any reported safety concerns, suggesting it is generally safe for humans.
12346How is the treatment of recorded music for epilepsy different from other treatments?
This treatment is unique because it uses specific music, like Mozart's Sonata K.448, to reduce seizure activity and epileptiform discharges, offering a non-drug, auditory approach that can be more easily integrated into daily life compared to traditional medication.
12456Eligibility Criteria
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.Inclusion Criteria
I am a child aged 4-17 staying in an Epilepsy Monitoring Unit for up to 7 days.
Exclusion Criteria
Non-English Speaking
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants listen to Mozart K.448 and instrumental age-appropriate songs with washout periods in between during EMU stays
Up to 7 days
2 to 7 EMU stay days
Follow-up
Participants are monitored for changes in epileptiform discharges, heart rate variability, and blood pressure variability
1 week
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins School of MedicineBaltimore, MD
Loading ...
Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
References
Mozart K.448 and epileptiform discharges: effect of ratio of lower to higher harmonics. [2010]Certain music has been shown to improve mental function, leading to what is known as the Mozart effect. This study measured the impact of Mozart's Sonata for two pianos in D major, K.448, on different epileptic foci of epileptiform discharge in Taiwanese children (n=58) with seizure disorders and investigated the characteristics of the musical stimulus presented that resulted in epileptiform discharge reduction.
The acute effect of music on interictal epileptiform discharges. [2007]This study was a prospective, randomized, single-blinded, crossover, placebo-controlled, pilot clinical trial investigating the effect of Mozart's Sonata for Two Pianos (K448) on the frequency of interictal epileptiform discharges (IEDs) from the EEGs of children with benign childhood epilepsy with centrotemporal spikes, or "rolandic" epilepsy. The goal was to demonstrate decreased frequency of IEDs with exposure to K448. Four subjects were recruited and 4-hour awake EEG recordings performed. IED frequency per minute was averaged over each of three epochs per hour. Mean IED count per epoch, standard deviations, and variance were calculated. Only complete waking epochs were analyzed. Two subjects demonstrated sufficient waking IEDs for statistical analysis, consisting of three epochs of K448-related effects. Significant decreases in IEDs per minute (33.7, 50.6, and 33.9%) were demonstrated comparing baseline with exposure to K448, but not to control music (Beethoven's Für Elise).
Mozart effect in epilepsy: Why is Mozart better than Haydn? Acoustic qualities-based analysis of stereoelectroencephalography. [2021]We aimed to confirm the Mozart effect in epileptic patients using intracerebral electroencephalography recordings and the hypothesis that the reduction of epileptiform discharges (EDs) can be explained by the music's acoustic properties.
Safe and sound: Meta-analyzing the Mozart effect on epilepsy. [2021]The use of music-based neuro-stimulation for treating seizures and interictal epileptiform discharges (IED) (the so-called "Mozart effect") remains a controversial issue. We have conducted an updated meta-analysis in order to systematically review literature evidence and provide further insights about the role of the Mozart effect in epilepsy.
Mozart's music in children with drug-refractory epileptic encephalopathies: Comparison of two protocols. [2018]In this prospective, randomized, open label study, we compared the effect on seizure recurrence and quality-of-life parameters, of two different protocols of music therapy in children and adolescents with refractory epileptic encephalopathies. Nine out of 19 patients (13 males and 6 females, aged between 1 and 24years) were randomized to listen to Mozart's sonata in D major for two pianos K448 for 2h/day for 2weeks; other 10 children were randomized on a set of Mozart's compositions. In group 1 (K448), 2/9 children (22.2%) had a ≥75% seizure decrease; two patients had less than 50% seizure reduction, and the other five were unchanged. In group 2 (set Mozart), 7/10 patients (70%) had a significant seizure reduction (specifically, ≥50% in 1/10; ≥75% in 4/10; 100% in 2/10). An overall more significant behavioral improvement including less irritability and tearfulness, reduced self-/heteroaggression, a better daytime vigilance, and nighttime sleep quality, was also reported in children from group 2. In conclusion, the present study seems to confirm that music therapy may be an additional, nonpharmacological, effective treatment for patients with refractory epileptic seizures in childhood. The Mozart's set of different compositions can be better accepted and effective than the K448.
Mozart K.448 listening decreased seizure recurrence and epileptiform discharges in children with first unprovoked seizures: a randomized controlled study. [2021]Increasing numbers of reports show the beneficial effects of listening to Mozart music in decreasing epileptiform discharges as well as seizure frequency in epileptic children. There has been no effective method to reduce seizure recurrence after the first unprovoked seizure until now. In this study, we investigated the effect of listening to Mozart K.448 in reducing the seizure recurrence rate in children with first unprovoked seizures.