Music as an Adjunctive Epileptic Seizure Treatment Option

NCT05545540 | Unknown

• 1 other identifier: 1-106-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Mozart's Sonata for two pianos in D major (K448) has been found to reduce the presence of abnormalities in the electroencephalograms of patients with epilepsy. We will examine the long term effects of listening to the K448 sonata on seizure frequency and cognitive functioning in children with drug resistant epilepsy allocated to either a study group or a control group. Patients' parents will complete a seizure diary for the whole study period, during which antiepileptic drug therapy of the child will remain unchanged. Baseline neuropsychological testing will be performed and a seizure diary will be kept for 3 months. The study group will listen to K448 for 8 continuous minutes every day for 2 months, while those in the control group will listen to control music for the same amount of time. Neuropsychological testing will be repeated at the end of the study period and any change from baseline examined. Seizure frequency during periods of exposure to music will be compared to baseline in both groups. Feedback questionnaires and parent focus groups will be used to gather information around the practicalities of exposure to music, potential problems and suggestions for how future studies might be improved.

Conditions

Epilepsy; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency

  Changes in epileptic seizure frequency before and after exposure to musical neurostimulation.

  4 months after recruitment

Secondary Outcomes (6)

• Changes in cognitive functioning from baseline to follow-up (at 2 months) on the Bayley Scales of Infant and Toddler Development-Third Edition, Screening Test.

  4 months after recruitment

• Changes in cognitive functioning from baseline to follow-up (at 2 months) on the Wechsler Preschool & Primary Scale of Intelligence-Fourth Edition (WPPSI-IV).

  4 months after recruitment

• Changes in cognitive functioning from baseline to follow-up (at 2 months) on the Wechsler Intelligence Scale for Children-Fifth Edition (WISC-V).

  4 months after recruitment

• Changes in cognitive functioning from baseline to follow-up (at 2 months) on the NEPSY-II.

  4 months after recruitment

• Changes in cognitive functioning from baseline to follow-up (at 2 months) on the Test of Everyday attention for Children (TEA-Ch).

  4 months after recruitment

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients will be issued Mp3 players and speakers with music files in Mp3 formatted by the randomization team. The intervention arm will be issued the first movement (8 minutes, 22 seconds) of Mozart's Sonata for Two Pianos in D Major, K448. They will be exposed to it once a day during wakefulness for two consecutive months.

Other: Musical Neurostimulation

Control arm

PLACEBO COMPARATOR

Patients will be issued Mp3 players and speakers with music files in Mp3 formatted by the randomization team. The control arm will receive the first movement (8 minutes, 34 seconds) of Mozart's Fantasia for Piano in C Minor, K 475. Although from the same composer, the control sonata has been found not to have neurostimulating properties. They will be exposed to it once a day during wakefulness for two consecutive months.

Other: Placebo Musical Neurostimuloation

Interventions

Musical Neurostimulation OTHER

Daily exposure to musical composition found to have antiseizure properties

Intervention arm

Placebo Musical Neurostimuloation OTHER

Daily exposure to musical composition found NOT to have antiseizure properties

Control arm

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with drug resistant epilepsy as per International League Against Epilepsy criteria: failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules to achieve sustained seizure freedom.

You may not qualify if:

• Children who undergo changes in ASM treatment during the study period.
• Children with a seizure frequency of less than two episodes per month.
• Children who underwent changes in ASM therapy less than one month before the study period.
• Children included in other clinical intervention studies at the time of recruitment.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Royal Aberdeen Children's Hospital

Aberdeen, AB25 2ZG, United Kingdom

RECRUITING

Related Publications (6)

• Hughes JR. The Mozart Effect. Epilepsy Behav. 2001 Oct;2(5):396-417. doi: 10.1006/ebeh.2001.0250.

  PMID: 12609277 BACKGROUND

• Leng X, Shaw GL, Wright EL. Coding of musical structure and trion model of cortex. Music Percept 1990;8(1):9-62.

  BACKGROUND

• Leng X, McGrann JV, Shaw GL. Reversal of epileptic state by patterned electrical stimulation suggested by trion model calculations. Neurol Res. 1992 Mar;14(1):57-61. doi: 10.1080/01616412.1992.11740012.

  PMID: 1351261 BACKGROUND

• Grylls E, Kinsky M, Baggott A, Wabnitz C, McLellan A. Study of the Mozart effect in children with epileptic electroencephalograms. Seizure. 2018 Jul;59:77-81. doi: 10.1016/j.seizure.2018.05.006. Epub 2018 May 9.

  PMID: 29763803 BACKGROUND

• Lin LC, Lee WT, Wang CH, Chen HL, Wu HC, Tsai CL, Wei RC, Mok HK, Weng CF, Lee MW, Yang RC. Mozart K.448 acts as a potential add-on therapy in children with refractory epilepsy. Epilepsy Behav. 2011 Mar;20(3):490-3. doi: 10.1016/j.yebeh.2010.12.044. Epub 2011 Feb 2.

  PMID: 21292560 BACKGROUND

• Sesso G, Sicca F. Safe and sound: Meta-analyzing the Mozart effect on epilepsy. Clin Neurophysiol. 2020 Jul;131(7):1610-1620. doi: 10.1016/j.clinph.2020.03.039. Epub 2020 Apr 30.

  PMID: 32449680 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Study Officials

• Domenico Serino, MD

  University of Aberdeen, NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Serino, MD

CONTACT

01224554897; domenico.serino@abnd.ac.uk

Bruce Downey

CONTACT

bruce.downey@nhs.scot

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: June 1, 2023
• Primary Completion: January 2, 2024
• Study Completion: February 2, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)