Music-listening During Deep Brain Stimulation to Relieve Anxiety

The Effects of Music Listening on Intra-operative Anxiety in Patients Undergoing Awake Deep Brain Stimulation for Movement Disorders.

This study aims to demonstrate that music listening in patients undergoing awake deep brain stimulation reduces subjective and objective measures of anxiety. Furthermore, the investigators aim to demonstrate that music may alter neuronal firing patterns based on the type of music played and the location in the brain.

Study Overview

• Status: Completed
• Conditions: Movement Disorders; Deep Brain Stimulation
• Intervention / Treatment: Other: Music-listening

Detailed Description

While conscious neurosurgical interventions are generally well-tolerated, they often cause some measure of pain and anxiety. Patients have been reported to suffer from recurring distressing recollections of, or dreams about, the surgery and other post-operative, Post-Traumatic Stress Disorder-like sequelae. High anxiety during surgery correlates with post-operative psychological disturbances. Notably, listening to music reduces anxiety in patients undergoing awake surgical procedures. Nonetheless, DBS is typically performed without music because ambient noise typically interferes with interpretation of neuronal recordings. Recording objective and subjective measures of stress during DBS provides a unique opportunity to determine the effect of music on intra-operative patient anxiety levels in patients listening to music compared to non-music listening control patients. The investigators hypothesize that playing music will improve intra-operative anxiety as measured by objective and subjective measures of stress, including blood pressure, heart rate, cortisol levels and anxiety questionnaires. Additionally, previous data in the investigator's lab has demonstrated that the subthalamic nucleus (STN) responds to melodic music by decreasing the average frequency of neuronal firing. The investigator's pilot study also suggests that STN and thalamic neurons respond differently to melodic music; the neurons in the STN increase synchrony of firing, while neurons in the thalamus decrease synchrony of firing over the course of the music clip. The investigators, therefore, aim to characterize the neuronal firing pattern changes in patients undergoing awake DBS procedures in greater detail, drawing from a larger sample size.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria:

• No previous DBS surgeries, no history of deafness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Music-listening group; Patients in this group will listen to music of their choosing during the entirety of the awake portion of deep brain stimulation surgery	Other: Music-listening; Patients listen to music on headphones
NO_INTERVENTION: Head-phone only group; Patients in this group will receive the same noise-canceling headphones as the patients in the music-listening group. However, they will remain without music per standard of care for awake deep brain stimulation procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol Response	Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Changes in blood pressure over time spent awake in surgery in music-listening patients vs headphones only patients	one year
Medication Requirements	Number and quantity of anti-hypertensives and sedatives required during awake surgery for music-listening vs headphones only patients	one year
Post-operative Recall Questionnaire	Satisfaction with surgery and subjective experience of whether music or headphones helped anxiety during surgery	one year

Collaborators and Investigators

• Sponsor: Darlene A. Lobel, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: 16-467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No