Music-listening During Deep Brain Stimulation to Relieve Anxiety

Not Applicable

Completed

• Conditions: Movement Disorders; Deep Brain Stimulation
• Interventions: Other: Music-listening

• Registration Number: NCT03091335
• Lead Sponsor: Darlene A. Lobel, MD

Brief Summary

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.

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 Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria

• No previous DBS surgeries, no history of deafness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music-listening group	Music-listening	Patients in this group will listen to music of their choosing during the entirety of the awake portion of deep brain stimulation surgery

Primary Outcome Measures

Name	Time	Method
Cortisol Response	one year	Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States