Effect of Music Therapy on Cognitive Recovery

Not Applicable

Withdrawn

• Conditions: Epilepsy
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT01947088
• Lead Sponsor: Seton Healthcare Family

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.

Study Timeline

• Study First Submitted: 2013-08-27
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstructured Play Arm	Music Therapy	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.)
Music Therapy Arm	Music Therapy	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.

Primary Outcome Measures

Name	Time	Method
Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group.	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.)

Trial Locations

Locations (1)

Dell Children's Medical Center of Central Texas; 🇺🇸 Austin, Texas, United States