Clinical Trial: Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury: the Prospective Randomized MU

Brief Summary:

Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients.

PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome.

Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well.

Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.


Detailed Summary:
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29) [ Time Frame: from desedation (Day 0) to Day 21. ]

The PSH-AM combines the sum of Clinical Features Scale [CFS] (from 0 to 18) and the Diagnostic Likelihood tool [DLT] (from 0 to 11)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Area under the Clinical Features Scale curve [ Time Frame: from Day 0 to Day 21. ]
  • Mean Analgesia Nociception Index [ Time Frame: from Day 0 to Day 21. ]
  • Neurological Pupil Index [ Time Frame: from Day 0 to Day 21. ]
  • Pain (Critical-Care Pain Observation Tool) [ Time Frame: from Day 0 to Day 21. ]
  • Neurological outcome (Wessex Head Injury Matrix) [ Time Frame: from Day 0 to Day 21. ]
  • PSH-AM [ Time Frame: Six and twelve months ]
  • Disability Rating Scale [ Time Frame: Six and twelve months ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: May 23, 2016
Date Started: November 2016
Date Completion: August 2021
Last Updated: November 21, 2016
Last Verified: November 2016