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Music-listening During Deep Brain Stimulation to Relieve Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03091335
Enrollment
10
Registered
2017-03-27
Start date
2016-07-01
Completion date
2017-11-30
Last updated
2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Movement Disorders

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.

Interventions

OTHERMusic-listening

Patients listen to music on headphones

Sponsors

Darlene A. Lobel, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

Randomization into two groups: music-listening vs headphones-only

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion criteria

* No previous DBS surgeries, no history of deafness

Design outcomes

Primary

MeasureTime frameDescription
Cortisol Responseone yearRatio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients

Secondary

MeasureTime frameDescription
Blood Pressureone yearChanges in blood pressure over time spent awake in surgery in music-listening patients vs headphones only patients
Medication Requirementsone yearNumber and quantity of anti-hypertensives and sedatives required during awake surgery for music-listening vs headphones only patients
Post-operative Recall Questionnaireone yearSatisfaction with surgery and subjective experience of whether music or headphones helped anxiety during surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026