Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury (MUSIC-TCNV)

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

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.

Study Overview

• Status: Terminated
• Conditions: Paroxysmal Sympathetic Hyperactivity
• Intervention / Treatment: Other: Musical intervention; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Service d'Anesthésie Réanimation- Hôpital de Hautepierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musical intervention; 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
Sham Comparator: Control; 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; 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: Fondation Apicil; MDMS; Association française des traumatisés crâniens d'Alsace; Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2016
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Music therapy; Paroxysmal sympathetic hyperactivity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Dyskinesias; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Hyperkinesis
• Other Study ID Numbers: 6224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No