EpilepsyNCT01947088
Effect of Music Therapy on Cognitive Recovery
A study testing Music Therapy in people with Epilepsy, run by Seton Healthcare Family at 1 site in United States.
Trial summary
Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 6-16 years of age
- Will undergo either a brain resection or lobectomy
Who cannot join
- Pre-surgical Full Scale IQ below 70
- Primary language is not English
- Hearing or vision impairments
- Parental consent cannot be obtained
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
About this study
Official title: I. The Effect of Music Therapy on Cognitive Recovery From Pediatric Epilepsy Surgery
Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery.
Read the detailed description
Music therapy could have a significant impact on clinical outcomes for patients with epilepsy. One study found that epilepsy patients who received music therapy for six months or greater had a significant reduction in number of seizures and could potentially aid in decreasing medication dosage. The investigators would like to contribute to this sort of research, but focus on what effect music therapy has on a patient's cognitive recovery after undergoing epilepsy surgery. Although research exists regarding music therapy on memory and communication, its overall effect on this patient population is unclear.
The Dell Children's Epilepsy program hopes that this research project on memory and communication will have a positive effect on their patients with epilepsy.
- Conditions
- Epilepsy
- Being tested
- Music Therapy
- Keywords
- Epilepsy, seizure disorder
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Will consist of meeting with the music therapists, Certified Child Life Specialists (CCLS), or Child Life Assistants (CLA) for either music therapy for about 45 minutes, twice per week, for Weeks 1-8. The Music Therapy group will partake in interventions such as singing and playing musical instruments. All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.)
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Arm | Experimental | Music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.) Pre-study and post-study scores from the neuropsychological assessments will be compared to determine if music therapy has a significant effect on the child's cognitive recovery. Will consist of meeting with the music therapists, Certified Child Life Specialists (CCLS), or Child Life Assistants (CLA) for music therapy (treatment group) for about 45 minutes, twice per week, for Weeks 1-8. CThe Music Therapy group will partake in interventions such as singing and playing musical instruments. Receives: Behavioral: Music Therapy |
| Unstructured Play Arm | Active comparator | Child life programs provide children with opportunities to engage in normal play and recreational activities that promote growth, development and feelings of success and fulfillment.All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). This is the standard of care for all brain surgery patients. The results of this assessment and will be used in this research study. In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.) Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group.
All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). This is the standard of care for all brain surgery patients. The results of this assessment and will be used in this research study. In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.)
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Principal Investigator left facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Townsend, MMT, Principal investigator, Seton Healthcare Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947088
- Sponsor's protocol ID
- CR-13-087
- Status last verified
- Jan 2015
- First submitted
- 27 Aug 2013
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I. The Effect of Music Therapy on Cognitive Recovery From Pediatric Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT01947088
- Acronym / sponsor ID
- CR-13-087
- Conditions
- Epilepsy
- Keywords
- Epilepsy, seizure disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left facility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Sep 2013 (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.
Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery.
Detailed description
Music therapy could have a significant impact on clinical outcomes for patients with epilepsy. One study found that epilepsy patients who received music therapy for six months or greater had a significant reduction in number of seizures and could potentially aid in decreasing medication dosage. The investigators would like to contribute to this sort of research, but focus on what effect music therapy has on a patient's cognitive recovery after undergoing epilepsy surgery. Although research exists regarding music therapy on memory and communication, its overall effect on this patient population is unclear.
The Dell Children's Epilepsy program hopes that this research project on memory and communication will have a positive effect on their patients with epilepsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Arm | Experimental | Behavioral: Music TherapyMusic therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.) Pre-study and post-study scores from the neuropsychological assessments will be compared to determine if music therapy has a significant effect on the child's cognitive recovery. Will consist of meeting with the music therapists, Certified Child Life Specialists (CCLS), or Child Life Assistants (CLA) for music therapy (treatment group) for about 45 minutes, twice per week, for Weeks 1-8. CThe Music Therapy group will partake in interventions such as singing and playing musical instruments. |
| Unstructured Play Arm | Active comparator | Behavioral: Music TherapyChild life programs provide children with opportunities to engage in normal play and recreational activities that promote growth, development and feelings of success and fulfillment.All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). This is the standard of care for all brain surgery patients. The results of this assessment and will be used in this research study. In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.) |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between 6-16 years of age
- Will undergo either a brain resection or lobectomy
Key exclusion criteria (4 listed)
- Pre-surgical Full Scale IQ below 70
- Primary language is not English
- Hearing or vision impairments
- Parental consent cannot be obtained
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 |
|---|---|---|
| Music TherapyWill consist of meeting with the music therapists, Certified Child Life Specialists (CCLS), or Child Life Assistants (CLA) for either music therapy for about 45 minutes, twice per week, for Weeks 1-8. The Music Therapy group will partake in interventions such as singing and playing musical instruments. All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.) | Behavioural | Music Therapy Arm, Unstructured Play Arm |
Primary outcome
Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group.
Time frame: 12 months post surgery
All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). This is the standard of care for all brain surgery patients. The results of this assessment and will be used in this research study. In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
Jennifer Townsend, MMT principal investigator
Seton Healthcare Family
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Epilepsy, run by Seton Healthcare Family 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jan 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group. (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
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 8 Jan 2015.