Music-listening During Deep Brain Stimulation to Relieve Anxiety

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Movement Disorders, Deep Brain Stimulation

Intervention / Treatment
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* Other: Music-listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STN or VIM targeted DBS surgery, awake DBS surgery Exclusion Criteria: No previous DBS surgeries, no history of deafness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into two groups: music-listening vs headphones-only
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music-listening group<br>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<br>* Patients listen to music on headphones<br>|
| No Intervention: Head-phone only group<br>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?
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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 |