Acute effects of Mozart K.448 on interictal epileptiform discharges in adult patients with drug-resistant focal epilepsy: A crossover randomized controlled trial
•Despite its promising effects in epilepsy, only few studies have evaluated the Mozart effect in a randomized controlled trial (RCT) design.•Our crossover RCT study demonstrated significant effects of Mozart K.448 in reducing IEDs, especially in patients with temporal epileptic foci.•Its long-term e...
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Published in | Seizure (London, England) Vol. 123; pp. 66 - 73 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Elsevier Ltd
01.12.2024
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Subjects | |
Online Access | Get full text |
ISSN | 1059-1311 1532-2688 1532-2688 |
DOI | 10.1016/j.seizure.2024.10.016 |
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Abstract | •Despite its promising effects in epilepsy, only few studies have evaluated the Mozart effect in a randomized controlled trial (RCT) design.•Our crossover RCT study demonstrated significant effects of Mozart K.448 in reducing IEDs, especially in patients with temporal epileptic foci.•Its long-term effect in helping control seizures is of great interest for further investigation.
This study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant focal epilepsy (DRE).
This is a crossover RCT study. Adults with DRE were included. Stratified 1:1 randomization by epileptic foci i.e., temporal versus extratemporal foci, was performed. Intervention consisted of two study arms i.e., “Mozart arm” and “Control arm”. Study period encompassed 2 consecutive nights, each night consisted of baseline and intervention period. Outcomes were IED number and proportion of patients with significant IED reduction i.e., reduction ≥ 25 %. Within-group, within-subject and between-group analyses were used to test differences of IED number when listened to the Mozart piece as compared with baseline or with Control.
Twenty-six patients were randomized; 13 in Mozart and 13 in Control arm. Overall, 16 (61.54 %) out of 26 patients had significant IED reduction when listening to the Mozart piece, as compared with only 7 (26.92 %) when continuing sleep (silence). Between-group analysis showed that IED number during intervention period i.e., listening to the Mozart piece in Mozart arm and silence in Control arm was significantly different, with a lower number in Mozart arm, 39.5 (IQR 89) vs 56.5 (IQR 114); p = 0.007.
Our study demonstrates an acute effect of the Mozart K.448 on reducing IEDs in adult patients with DRE. Patients with temporal rather than extratemporal lobe epilepsy better responded to the Mozart piece. Mozart K.448 is safe and feasible in real practice. Further RCT study assessing its long-term effect is warranted.
Thai Clinical Trials Registry, TCTR20231019005, 19 October 2023, “retrospectively registered” |
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AbstractList | •Despite its promising effects in epilepsy, only few studies have evaluated the Mozart effect in a randomized controlled trial (RCT) design.•Our crossover RCT study demonstrated significant effects of Mozart K.448 in reducing IEDs, especially in patients with temporal epileptic foci.•Its long-term effect in helping control seizures is of great interest for further investigation.
This study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant focal epilepsy (DRE).
This is a crossover RCT study. Adults with DRE were included. Stratified 1:1 randomization by epileptic foci i.e., temporal versus extratemporal foci, was performed. Intervention consisted of two study arms i.e., “Mozart arm” and “Control arm”. Study period encompassed 2 consecutive nights, each night consisted of baseline and intervention period. Outcomes were IED number and proportion of patients with significant IED reduction i.e., reduction ≥ 25 %. Within-group, within-subject and between-group analyses were used to test differences of IED number when listened to the Mozart piece as compared with baseline or with Control.
Twenty-six patients were randomized; 13 in Mozart and 13 in Control arm. Overall, 16 (61.54 %) out of 26 patients had significant IED reduction when listening to the Mozart piece, as compared with only 7 (26.92 %) when continuing sleep (silence). Between-group analysis showed that IED number during intervention period i.e., listening to the Mozart piece in Mozart arm and silence in Control arm was significantly different, with a lower number in Mozart arm, 39.5 (IQR 89) vs 56.5 (IQR 114); p = 0.007.
Our study demonstrates an acute effect of the Mozart K.448 on reducing IEDs in adult patients with DRE. Patients with temporal rather than extratemporal lobe epilepsy better responded to the Mozart piece. Mozart K.448 is safe and feasible in real practice. Further RCT study assessing its long-term effect is warranted.
Thai Clinical Trials Registry, TCTR20231019005, 19 October 2023, “retrospectively registered” This study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant focal epilepsy (DRE).BACKGROUNDThis study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant focal epilepsy (DRE).This is a crossover RCT study. Adults with DRE were included. Stratified 1:1 randomization by epileptic foci i.e., temporal versus extratemporal foci, was performed. Intervention consisted of two study arms i.e., "Mozart arm" and "Control arm". Study period encompassed 2 consecutive nights, each night consisted of baseline and intervention period. Outcomes were IED number and proportion of patients with significant IED reduction i.e., reduction ≥ 25 %. Within-group, within-subject and between-group analyses were used to test differences of IED number when listened to the Mozart piece as compared with baseline or with Control.METHODSThis is a crossover RCT study. Adults with DRE were included. Stratified 1:1 randomization by epileptic foci i.e., temporal versus extratemporal foci, was performed. Intervention consisted of two study arms i.e., "Mozart arm" and "Control arm". Study period encompassed 2 consecutive nights, each night consisted of baseline and intervention period. Outcomes were IED number and proportion of patients with significant IED reduction i.e., reduction ≥ 25 %. Within-group, within-subject and between-group analyses were used to test differences of IED number when listened to the Mozart piece as compared with baseline or with Control.Twenty-six patients were randomized; 13 in Mozart and 13 in Control arm. Overall, 16 (61.54 %) out of 26 patients had significant IED reduction when listening to the Mozart piece, as compared with only 7 (26.92 %) when continuing sleep (silence). Between-group analysis showed that IED number during intervention period i.e., listening to the Mozart piece in Mozart arm and silence in Control arm was significantly different, with a lower number in Mozart arm, 39.5 (IQR 89) vs 56.5 (IQR 114); p = 0.007.RESULTSTwenty-six patients were randomized; 13 in Mozart and 13 in Control arm. Overall, 16 (61.54 %) out of 26 patients had significant IED reduction when listening to the Mozart piece, as compared with only 7 (26.92 %) when continuing sleep (silence). Between-group analysis showed that IED number during intervention period i.e., listening to the Mozart piece in Mozart arm and silence in Control arm was significantly different, with a lower number in Mozart arm, 39.5 (IQR 89) vs 56.5 (IQR 114); p = 0.007.Our study demonstrates an acute effect of the Mozart K.448 on reducing IEDs in adult patients with DRE. Patients with temporal rather than extratemporal lobe epilepsy better responded to the Mozart piece. Mozart K.448 is safe and feasible in real practice. Further RCT study assessing its long-term effect is warranted.CONCLUSIONSOur study demonstrates an acute effect of the Mozart K.448 on reducing IEDs in adult patients with DRE. Patients with temporal rather than extratemporal lobe epilepsy better responded to the Mozart piece. Mozart K.448 is safe and feasible in real practice. Further RCT study assessing its long-term effect is warranted.Thai Clinical Trials Registry, TCTR20231019005, 19 October 2023, "retrospectively registered".TRIAL REGISTRATIONThai Clinical Trials Registry, TCTR20231019005, 19 October 2023, "retrospectively registered". This study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant focal epilepsy (DRE). This is a crossover RCT study. Adults with DRE were included. Stratified 1:1 randomization by epileptic foci i.e., temporal versus extratemporal foci, was performed. Intervention consisted of two study arms i.e., "Mozart arm" and "Control arm". Study period encompassed 2 consecutive nights, each night consisted of baseline and intervention period. Outcomes were IED number and proportion of patients with significant IED reduction i.e., reduction ≥ 25 %. Within-group, within-subject and between-group analyses were used to test differences of IED number when listened to the Mozart piece as compared with baseline or with Control. Twenty-six patients were randomized; 13 in Mozart and 13 in Control arm. Overall, 16 (61.54 %) out of 26 patients had significant IED reduction when listening to the Mozart piece, as compared with only 7 (26.92 %) when continuing sleep (silence). Between-group analysis showed that IED number during intervention period i.e., listening to the Mozart piece in Mozart arm and silence in Control arm was significantly different, with a lower number in Mozart arm, 39.5 (IQR 89) vs 56.5 (IQR 114); p = 0.007. Our study demonstrates an acute effect of the Mozart K.448 on reducing IEDs in adult patients with DRE. Patients with temporal rather than extratemporal lobe epilepsy better responded to the Mozart piece. Mozart K.448 is safe and feasible in real practice. Further RCT study assessing its long-term effect is warranted. Thai Clinical Trials Registry, TCTR20231019005, 19 October 2023, "retrospectively registered". |
Author | Kiatprungvech, Thanakorn Limotai, Chusak Tosamran, Somjet Asavalertpalakorn, Thtiwat Pakotiprapha, Thanaporn Surawattanawong, Totsapol |
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Keywords | Mozart K.448 Interictal epileptiform discharges Drug-resistant epilepsy Acute effects |
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Snippet | •Despite its promising effects in epilepsy, only few studies have evaluated the Mozart effect in a randomized controlled trial (RCT) design.•Our crossover RCT... This study aimed to validly assess the efficacy of Mozart K.448 on reducing interictal epileptiform discharges (IEDs) in adult patients with drug-resistant... |
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SubjectTerms | Acute effects Adult Cross-Over Studies Drug Resistant Epilepsy - physiopathology Drug-resistant epilepsy Electroencephalography Epilepsies, Partial - drug therapy Epilepsies, Partial - physiopathology Female Humans Interictal epileptiform discharges Male Middle Aged Mozart K.448 Music Therapy - methods Treatment Outcome Young Adult |
Title | Acute effects of Mozart K.448 on interictal epileptiform discharges in adult patients with drug-resistant focal epilepsy: A crossover randomized controlled trial |
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