Photoparoxysmal AbnormalitiesNCT01363154
Prevention of Photoparoxysmal Abnormalities by Mozart K448
A study testing Mozart K448, Beethoven's Für Elise and No music exposure in people with Photoparoxysmal Abnormalities and Epilepsy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Photoparoxysmal Abnormalities, Epilepsy, Seizures
- What is being tested?
- Mozart K448, Beethoven's Für Elise and No music exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2013
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-17 years, inclusive
- Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
- Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
- On < or equal to 2 anti-seizure medications [range 0-2 AEDs]
Who cannot join
- History of a generalized convulsion provoked by photic stimulation;
- Inability to complete and/or comply with study protocol
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: Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.
Read the detailed description
Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects.
Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during:
- Treatment: music exposure to Mozart K448, vs.
- Placebo: music exposure to Beethoven's Für Elise for piano, vs.
- Control: no music exposure.
- Conditions
- Photoparoxysmal Abnormalities, Epilepsy, Seizures
- Being tested
- Mozart K448, Beethoven's Für Elise, No music exposure
- Keywords
- Children's Health, Pediatrics, Epilepsy, Photoparoxysmal, Photosensitive, Music, Mozart, K-448
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozart K448Other
Also called Mozart's Sonata for Two Pianos in D Major, K448
Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.
Beethoven's Für EliseOther
Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.
No music exposureOther
Also called Control: No music exposure.
Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.
| Study group | Role | What they receive |
|---|---|---|
| Mozart K448 | Active comparator | Treatment: music exposure to Mozart K448 Receives: Other: Mozart K448 |
| Beethoven's Für Elise | Placebo comparator | Placebo: music exposure to Beethoven's Für Elise for piano Receives: Other: Beethoven's Für Elise; Other: No music exposure |
| No music exposure | No intervention | Control: no music exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
Each participant will have a single one hour EEG for data aquistition. The recorded EEG data will be analyzed to determine significant causal reductions or prevention of photoparoxysmal responses resulting from the auditory stimulation, along with determining all induced patterns of cortical activation.
Measured: Each participant will have a single one hour EEG for data aquistition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Photoparoxysmal AbnormalitiesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 CarolinaMark Bodner, MD, Principal investigator, MIND InstituteLee Anne Tetrick, BS, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363154
- Sponsor's protocol ID
- 7683
- Status last verified
- Jun 2013
- First submitted
- 27 May 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banerjee PN, Filippi D, Allen Hauser W. The descriptive epidemiology of epilepsy-a review. Epilepsy Res. 2009 Jul;85(1):31-45. doi: 10.1016/j.eplepsyres.2009.03.003. Epub 2009 Apr 15.
PubMed 19369037Bodner M, Muftuler LT, Nalcioglu O, Shaw GL. FMRI study relevant to the Mozart effect: brain areas involved in spatial-temporal reasoning. Neurol Res. 2001 Oct;23(7):683-90. doi: 10.1179/016164101101199108.
PubMed 11680506Davis R, Emmonds SE. Cerebellar stimulation for seizure control: 17-year study. Stereotact Funct Neurosurg. 1992;58(1-4):200-8. doi: 10.1159/000098996.
PubMed 1439341Engel J Jr; International League Against Epilepsy (ILAE). A proposed diagnostic scheme for people with epileptic seizures and with epilepsy: report of the ILAE Task Force on Classification and Terminology. Epilepsia. 2001 Jun;42(6):796-803. doi: 10.1046/j.1528-1157.2001.10401.x. No abstract available.
PubMed 11422340Fisher RS, Uematsu S, Krauss GL, Cysyk BJ, McPherson R, Lesser RP, Gordon B, Schwerdt P, Rise M. Placebo-controlled pilot study of centromedian thalamic stimulation in treatment of intractable seizures. Epilepsia. 1992 Sep-Oct;33(5):841-51. doi: 10.1111/j.1528-1157.1992.tb02192.x.
PubMed 1396427Fisher RS, Harding G, Erba G, Barkley GL, Wilkins A; Epilepsy Foundation of America Working Group. Photic- and pattern-induced seizures: a review for the Epilepsy Foundation of America Working Group. Epilepsia. 2005 Sep;46(9):1426-41. doi: 10.1111/j.1528-1167.2005.31405.x.
PubMed 16146439Hughes JR, Daaboul Y, Fino JJ, Shaw GL. The "Mozart effect" on epileptiform activity. Clin Electroencephalogr. 1998 Jul;29(3):109-19. doi: 10.1177/155005949802900301.
PubMed 9660010Hughes JR, Fino JJ, Melyn MA. Is there a chronic change of the "Mozart effect" on epileptiform activity? A case study. Clin Electroencephalogr. 1999 Apr;30(2):44-5. doi: 10.1177/155005949903000204.
PubMed 10358782Hughes JR. The Mozart Effect. Epilepsy Behav. 2001 Oct;2(5):396-417. doi: 10.1006/ebeh.2001.0250.
PubMed 12609277Hughes JR. The Mozart Effect: Additional Data. Epilepsy Behav. 2002 Apr;3(2):182-184. doi: 10.1006/ebeh.2002.0329.
PubMed 12609420Jacobs MP, Fischbach GD, Davis MR, Dichter MA, Dingledine R, Lowenstein DH, Morrell MJ, Noebels JL, Rogawski MA, Spencer SS, Theodore WH. Future directions for epilepsy research. Neurology. 2001 Nov 13;57(9):1536-42. doi: 10.1212/wnl.57.9.1536.
PubMed 11706087Lahiri N, Duncan JS. The Mozart effect: encore. Epilepsy Behav. 2007 Aug;11(1):152-3. doi: 10.1016/j.yebeh.2007.04.017. Epub 2007 Jun 29.
PubMed 17602882Macdonell RA, Curatolo JM, Berkovic SF. Transcranial magnetic stimulation and epilepsy. J Clin Neurophysiol. 2002 Aug;19(4):294-306. doi: 10.1097/00004691-200208000-00004.
PubMed 12436086Kasteleijn-Nolst Trenite DG, Binnie CD, Harding GF, Wilkins A. Photic stimulation: standardization of screening methods. Epilepsia. 1999;40 Suppl 4:75-9. doi: 10.1111/j.1528-1157.1999.tb00911.x.
PubMed 10487178Kasteleijn-Nolst Trenite DG, van der Beld G, Heynderickx I, Groen P. Visual stimuli in daily life. Epilepsia. 2004;45 Suppl 1:2-6. doi: 10.1111/j.0013-9580.2004.451004.x.
PubMed 14706037
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
- ClinicalTrials.gov ID
- NCT01363154
- Acronym / sponsor ID
- 7683
- Conditions
- Photoparoxysmal Abnormalities, Epilepsy, Seizures
- Keywords
- Children's Health, Pediatrics, Epilepsy, Photoparoxysmal, Photosensitive, Music, Mozart, K-448
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Jun 2011 (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 clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.
Detailed description
Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects.
Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during:
- Treatment: music exposure to Mozart K448, vs.
- Placebo: music exposure to Beethoven's Für Elise for piano, vs.
- Control: no music exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mozart K448 | Active comparator | Other: Mozart K448Treatment: music exposure to Mozart K448 |
| Beethoven's Für Elise | Placebo comparator | Other: Beethoven's Für Elise, Other: No music exposurePlacebo: music exposure to Beethoven's Für Elise for piano |
| No music exposure | No intervention | –Control: no music exposure |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 5-17 years, inclusive
- Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
- Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
- On < or equal to 2 anti-seizure medications [range 0-2 AEDs]
Key exclusion criteria (2 listed)
- History of a generalized convulsion provoked by photic stimulation;
- Inability to complete and/or comply with study protocol
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 K448Also: Mozart's Sonata for Two Pianos in D Major, K448Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448. | Other | Mozart K448 |
| Beethoven's Für EliseSubjects will receive auditory stimulation by exposure to Beethoven's Für Elise. | Other | Beethoven's Für Elise |
| No music exposureAlso: Control: No music exposure.Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music. | Other | Beethoven's Für Elise |
Primary outcome
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
Time frame: Each participant will have a single one hour EEG for data aquistition.
Each participant will have a single one hour EEG for data aquistition. The recorded EEG data will be analyzed to determine significant causal reductions or prevention of photoparoxysmal responses resulting from the auditory stimulation, along with determining all induced patterns of cortical activation.
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Background: PubMed 19369037Banerjee PN, Filippi D, Allen Hauser W. The descriptive epidemiology of epilepsy-a review. Epilepsy Res. 2009 Jul;85(1):31-45. doi: 10.1016/j.eplepsyres.2009.03.003. Epub 2009 Apr 15.
- Background: PubMed 11680506Bodner M, Muftuler LT, Nalcioglu O, Shaw GL. FMRI study relevant to the Mozart effect: brain areas involved in spatial-temporal reasoning. Neurol Res. 2001 Oct;23(7):683-90. doi: 10.1179/016164101101199108.
- Background: PubMed 1439341Davis R, Emmonds SE. Cerebellar stimulation for seizure control: 17-year study. Stereotact Funct Neurosurg. 1992;58(1-4):200-8. doi: 10.1159/000098996.
- Background: PubMed 11422340Engel J Jr; International League Against Epilepsy (ILAE). A proposed diagnostic scheme for people with epileptic seizures and with epilepsy: report of the ILAE Task Force on Classification and Terminology. Epilepsia. 2001 Jun;42(6):796-803. doi: 10.1046/j.1528-1157.2001.10401.x. No abstract available.
- Background: PubMed 1396427Fisher RS, Uematsu S, Krauss GL, Cysyk BJ, McPherson R, Lesser RP, Gordon B, Schwerdt P, Rise M. Placebo-controlled pilot study of centromedian thalamic stimulation in treatment of intractable seizures. Epilepsia. 1992 Sep-Oct;33(5):841-51. doi: 10.1111/j.1528-1157.1992.tb02192.x.
- Background: PubMed 16146439Fisher RS, Harding G, Erba G, Barkley GL, Wilkins A; Epilepsy Foundation of America Working Group. Photic- and pattern-induced seizures: a review for the Epilepsy Foundation of America Working Group. Epilepsia. 2005 Sep;46(9):1426-41. doi: 10.1111/j.1528-1167.2005.31405.x.
- Background: PubMed 9660010Hughes JR, Daaboul Y, Fino JJ, Shaw GL. The "Mozart effect" on epileptiform activity. Clin Electroencephalogr. 1998 Jul;29(3):109-19. doi: 10.1177/155005949802900301.
- Background: PubMed 10358782Hughes JR, Fino JJ, Melyn MA. Is there a chronic change of the "Mozart effect" on epileptiform activity? A case study. Clin Electroencephalogr. 1999 Apr;30(2):44-5. doi: 10.1177/155005949903000204.
- Background: PubMed 12609277Hughes JR. The Mozart Effect. Epilepsy Behav. 2001 Oct;2(5):396-417. doi: 10.1006/ebeh.2001.0250.
- Background: PubMed 12609420Hughes JR. The Mozart Effect: Additional Data. Epilepsy Behav. 2002 Apr;3(2):182-184. doi: 10.1006/ebeh.2002.0329.
- Background: PubMed 11706087Jacobs MP, Fischbach GD, Davis MR, Dichter MA, Dingledine R, Lowenstein DH, Morrell MJ, Noebels JL, Rogawski MA, Spencer SS, Theodore WH. Future directions for epilepsy research. Neurology. 2001 Nov 13;57(9):1536-42. doi: 10.1212/wnl.57.9.1536.
- Background: PubMed 17602882Lahiri N, Duncan JS. The Mozart effect: encore. Epilepsy Behav. 2007 Aug;11(1):152-3. doi: 10.1016/j.yebeh.2007.04.017. Epub 2007 Jun 29.
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
Mark Bodner, MD principal investigator
MIND Institute
Lee Anne Tetrick, BS study director
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 K448, Beethoven's Für Elise and No music exposure in people with Photoparoxysmal Abnormalities and Epilepsy, 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Jun 2013. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: terminated). Results are not available in the source record.
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.
What does the primary outcome measure?
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448 (time frame: Each participant will have a single one hour EEG for data aquistition.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363154, which also lists 29 linked publications.
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 4 Jun 2013.