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Effect of Music Therapy on Cognitive Recovery

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Seton Healthcare Family
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, seizure disorder

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 6-16 years of age
  • Will undergo either a brain resection or lobectomy

Exclusion Criteria:

  • Pre-surgical Full Scale IQ below 70
  • Primary language is not English
  • Hearing or vision impairments
  • Parental consent cannot be obtained

Sites / Locations

  • Dell Children's Medical Center of Central Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Therapy Arm

Unstructured Play Arm

Arm Description

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.

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.)

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2013
Last Updated
January 7, 2015
Sponsor
Seton Healthcare Family
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1. Study Identification

Unique Protocol Identification Number
NCT01947088
Brief Title
Effect of Music Therapy on Cognitive Recovery
Official Title
I. The Effect of Music Therapy on Cognitive Recovery From Pediatric Epilepsy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left facility
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seton Healthcare Family

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, seizure disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Unstructured Play Arm
Arm Type
Active Comparator
Arm Description
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.)
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group.
Description
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.)
Time Frame
12 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 6-16 years of age Will undergo either a brain resection or lobectomy Exclusion Criteria: Pre-surgical Full Scale IQ below 70 Primary language is not English Hearing or vision impairments Parental consent cannot be obtained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Townsend, MMT
Organizational Affiliation
Seton Healthcare Family
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States

12. IPD Sharing Statement

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Effect of Music Therapy on Cognitive Recovery

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