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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury: the Prospective Randomized MUSIC-TCNV Trial.

Conditions
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Paroxysmal Sympathetic Hyperactivity

Intervention / Treatment
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* Other: Musical intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe traumatic brain injury (either initial Glasgow Coma Scale < 8 or intracranial pressure > 20mmHg for more than 20 min) National health service coverage Informed consent signed by next of kin Exclusion Criteria: Non-traumatic brain injury Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis, Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation Respiratory rate < 9/min Patient subject to guardianship or wardship Pregnant or breastfeeding woman Current participation in another biomedical research protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Musical intervention<br>Music is provided through headphones: Two 30-min musical sessions per day (one in the morning and one in the evening) beginning at the onset of desedation (Day 0) until day 21. Both have inverted U shape. | Other: Musical intervention<br> <br> |
| Sham Comparator: Control<br>Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham | Other: Control<br>* Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music therapy, Paroxysmal sympathetic hyperactivity, Traumatic brain injury