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Clinical Trials/NCT03091335
NCT03091335
Completed
Not Applicable

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

Darlene A. Lobel, MD1 site in 1 country10 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Movement Disorders
Sponsor
Darlene A. Lobel, MD
Enrollment
10
Locations
1
Primary Endpoint
Cortisol Response
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
November 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Darlene A. Lobel, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Darlene A. Lobel, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria

  • No previous DBS surgeries, no history of deafness

Outcomes

Primary Outcomes

Cortisol Response

Time Frame: one year

Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients

Secondary Outcomes

  • Medication Requirements(one year)
  • Blood Pressure(one year)
  • Post-operative Recall Questionnaire(one year)

Study Sites (1)

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