Effect of Mozart K.448 on interictal epileptiform discharges in drug-resistant adult epilepsy patients in King Chulalongkorn Memorial hospital

Phase 1

Recruiting

• Conditions: Drug-resistant epilepsy; Mozart K.448; Drug-resistant epilepsy patients; Electroencephalography; Interictal epileptiform discharge; Quantitative Electroencephalography; Heart rate variability; Video EEG monitoring

• Registration Number: TCTR20231019005
• Lead Sponsor: Chulalongkorn Comprehensive Epilepsy Center of Excellence

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Study Completion: 2024-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Age more than 18 years old
2.Drug-resistant epilepsy was diagnosed
3.Stable antiseizure medication dose for 1 months before inclusion

Exclusion Criteria

1.Patients who refused to participate in the research
2.Patients who cannot do an EEG according to the 10-20 principle, such as patients undergoing cranial surgery.
3.Patients with hearing impairment
4.Patient was diagnosed with epilepsy caused by progressive neurological disease such as Rasmussen's encephalitis, mitochondrial disorders, inborn error of metabolism, autoimmune-associated epilepsy, etc.
5.Patients who tend to be unable to tolerate listening to Mozart K.448, such as those with intellectual disabilities and accompanying behavioral problems.
6.In the first 4-hour EEG recording during the first night of the study, there were fewer than 10 interictal epileptiform discharges.
7.The patient has a history of irregular heart rhythm known as atrial fibrillation.
8.The patient has a history of having a permanent pacemaker (PPM) implanted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interictal epileptiform discharge During intervention Pearson chi-square test or Fisher exact test

Secondary Outcome Measures

Name	Time	Method
Quantitative EEG During intervention Pearson chi-square test or Fisher exact test,Heart rate variability During intervention Pearson chi-square test or Fisher exact test