Rolandic EpilepsyNCT01515436
The Effect of Music Periodicity on Interictal Epileptiform Discharges
A study testing Mozart alternating with Beethoven and Beethoven alternating with Mozart in people with Rolandic Epilepsy and Benign Childhood Epilepsy With Centrotemporal Spikes, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy
- What is being tested?
- Mozart alternating with Beethoven and Beethoven alternating with Mozart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Female or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.
- EEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG
- Screening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)
- Age 5-12 years, inclusive
- On less than or equal to 2 anti-epileptic drugs (AED) [Range 0-2 AEDs]
Who cannot join
- Currently taking Clonazepam or other Benzodiazepines
- Inability to complete 12 hour admission and comply with study protocol
- Prohibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.
- Due to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.
- For any subject experiencing a seizure during the study, data analysis will cease from that point onward.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges
The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy.
- Conditions
- Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy, Seizures
- Being tested
- Mozart alternating with Beethoven, Beethoven alternating with Mozart
- Keywords
- Rolandic Epilepsy, Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), Epilepsy, Seizures, Music, Mozart, Beethoven
- Medical subject headings
- Epilepsy, Rolandic, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozart alternating with BeethovenOther
Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.
Beethoven alternating with MozartOther
Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.
| Study group | Role | What they receive |
|---|---|---|
| Mozart alternating with Beethoven | Active comparator | Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise. Receives: Other: Mozart alternating with Beethoven |
| Beethoven alternating with Mozart | Active comparator | Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448. Receives: Other: Beethoven alternating with Mozart |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startFeb 2004
- Primary completionMay 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert P. Turner, Medical University of South Carolina
- Investigators
- Robert P Turner, MD, MSCR, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515436
- Sponsor's protocol ID
- HR11247
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges
- ClinicalTrials.gov ID
- NCT01515436
- Acronym / sponsor ID
- HR11247
- Conditions
- Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy, Seizures
- Keywords
- Rolandic Epilepsy, Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), Epilepsy, Seizures, Music, Mozart, Beethoven
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- May 2004 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mozart alternating with Beethoven | Active comparator | Other: Mozart alternating with BeethovenStudy participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise. |
| Beethoven alternating with Mozart | Active comparator | Other: Beethoven alternating with MozartStudy participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Female or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.
- EEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG
- Screening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)
- Age 5-12 years, inclusive
- On less than or equal to 2 anti-epileptic drugs (AED) [Range 0-2 AEDs]
Key exclusion criteria (5 listed)
- Currently taking Clonazepam or other Benzodiazepines
- Inability to complete 12 hour admission and comply with study protocol
- Prohibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.
- Due to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.
- For any subject experiencing a seizure during the study, data analysis will cease from that point onward.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mozart alternating with BeethovenStudy participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise. | Other | Mozart alternating with Beethoven |
| Beethoven alternating with MozartStudy participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448. | Other | Beethoven alternating with Mozart |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Turner, MD, MSCR principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mozart alternating with Beethoven and Beethoven alternating with Mozart in people with Rolandic Epilepsy and Benign Childhood Epilepsy With Centrotemporal Spikes, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.