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Clinical Trials/NCT03091335
NCT03091335CompletedNot 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 enrollmentStarted: July 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Cortisol Response

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participants will be unaware of their randomization group until all pre-operative measures have been acquired.

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria

  • •No previous DBS surgeries, no history of deafness

Arms & Interventions

Music-listening group

Experimental

Patients in this group will listen to music of their choosing during the entirety of the awake portion of deep brain stimulation surgery

Intervention: Music-listening (Other)

Head-phone only group

No Intervention

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

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)

Investigators

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

Darlene A. Lobel, MD

Principal Investigator

The Cleveland Clinic

Study Sites (1)

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