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Music-listening During Deep Brain Stimulation to Relieve Anxiety

Primary Purpose

Movement Disorders, Deep Brain Stimulation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music-listening
Sponsored by
Darlene A. Lobel, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria:

  • No previous DBS surgeries, no history of deafness

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music-listening group

Head-phone only group

Arm Description

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

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 Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2017
Last Updated
December 12, 2017
Sponsor
Darlene A. Lobel, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03091335
Brief Title
Music-listening During Deep Brain Stimulation to Relieve Anxiety
Official Title
The Effects of Music Listening on Intra-operative Anxiety in Patients Undergoing Awake Deep Brain Stimulation for Movement Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darlene A. Lobel, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders, Deep Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization into two groups: music-listening vs headphones-only
Masking
Participant
Masking Description
Participants will be unaware of their randomization group until all pre-operative measures have been acquired.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music-listening group
Arm Type
Experimental
Arm Description
Patients in this group will listen to music of their choosing during the entirety of the awake portion of deep brain stimulation surgery
Arm Title
Head-phone only group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Music-listening
Intervention Description
Patients listen to music on headphones
Primary Outcome Measure Information:
Title
Cortisol Response
Description
Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients
Time Frame
one year
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Changes in blood pressure over time spent awake in surgery in music-listening patients vs headphones only patients
Time Frame
one year
Title
Medication Requirements
Description
Number and quantity of anti-hypertensives and sedatives required during awake surgery for music-listening vs headphones only patients
Time Frame
one year
Title
Post-operative Recall Questionnaire
Description
Satisfaction with surgery and subjective experience of whether music or headphones helped anxiety during surgery
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: STN or VIM targeted DBS surgery, awake DBS surgery Exclusion Criteria: No previous DBS surgeries, no history of deafness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darlene Lobel, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Music-listening During Deep Brain Stimulation to Relieve Anxiety

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