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Music-listening During Deep Brain Stimulation to Relieve Anxiety

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ClinicalTrials.gov Identifier: NCT03091335
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Darlene A. Lobel, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Movement Disorders Deep Brain Stimulation Other: Music-listening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization into two groups: music-listening vs headphones-only
Masking: Single (Participant)
Masking Description: Participants will be unaware of their randomization group until all pre-operative measures have been acquired.
Primary Purpose: Treatment
Official Title: The Effects of Music Listening on Intra-operative Anxiety in Patients Undergoing Awake Deep Brain Stimulation for Movement Disorders.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Music-listening group
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
Patients listen to music on headphones

No Intervention: Head-phone only group
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Blood Pressure [ Time Frame: one year ]
    Changes in blood pressure over time spent awake in surgery in music-listening patients vs headphones only patients

  2. Medication Requirements [ Time Frame: one year ]
    Number and quantity of anti-hypertensives and sedatives required during awake surgery for music-listening vs headphones only patients

  3. Post-operative Recall Questionnaire [ Time Frame: one year ]
    Satisfaction with surgery and subjective experience of whether music or headphones helped anxiety during surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria:

  • No previous DBS surgeries, no history of deafness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091335


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Darlene A. Lobel, MD
Investigators
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Principal Investigator: Darlene Lobel, MD The Cleveland Clinic

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Responsible Party: Darlene A. Lobel, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03091335     History of Changes
Other Study ID Numbers: 16-467
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases