Music-listening During Deep Brain Stimulation to Relieve Anxiety

NCT03091335 | Completed

• 1 other identifier: 16-467
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Cortisol Response

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

  one year

Secondary Outcomes (3)

• Blood Pressure

  one year

• Medication Requirements

  one year

• Post-operative Recall Questionnaire

  one year

Study Arms (2)

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

Other: Music-listening

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

Interventions

Music-listening OTHER

Patients listen to music on headphones

Music-listening group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STN or VIM targeted DBS surgery, awake DBS surgery

You may not qualify if:

• No previous DBS surgeries, no history of deafness

Sponsors & Collaborators

• Darlene A. Lobel, MD: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Darlene Lobel, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their randomization group until all pre-operative measures have been acquired.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: July 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)