Effect of Music Therapy on Cognitive Recovery

NCT01947088 | Withdrawn

• 1 other identifier: CR-13-087
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

Epilepsy, seizure disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.)

Behavioral: Music Therapy

Interventions

Music Therapy BEHAVIORAL

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.)

Music Therapy Arm; Unstructured Play Arm

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Townsend, MMT

  Seton Healthcare Family

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (1)