Music-listening During Deep Brain Stimulation to Relieve Anxiety

Movement Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091335
• Other study ID #: 16-467
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: December 12, 2017
• Start date: July 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria:

• No previous DBS surgeries, no history of deafness

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Movement Disorders

Intervention

Other:
• Music-listening
Patients listen to music on headphones

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Darlene A. Lobel, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol Response	Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients	one year
Secondary	Blood Pressure	Changes in blood pressure over time spent awake in surgery in music-listening patients vs headphones only patients	one year
Secondary	Medication Requirements	Number and quantity of anti-hypertensives and sedatives required during awake surgery for music-listening vs headphones only patients	one year
Secondary	Post-operative Recall Questionnaire	Satisfaction with surgery and subjective experience of whether music or headphones helped anxiety during surgery	one year