Effect of Music Therapy on Cognitive Recovery

Epilepsy Clinical Trial

Official title:

I. The Effect of Music Therapy on Cognitive Recovery From Pediatric Epilepsy Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01947088
• Other study ID #: CR-13-087
• Status: Withdrawn
• Phase: N/A
• First received: August 27, 2013
• Last updated: January 7, 2015
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Music Therapy
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.)

Locations

Country	Name	City	State
United States	Dell Children's Medical Center of Central Texas	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	12 months post surgery	No