Clinical trial NCT02783105: Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury
Official title: Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury: the Prospective Randomized MUSIC-TCNV Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Sympathetic Hyperactivity
Keywords: Music therapy
Paroxysmal sympathetic hyperactivity
Traumatic brain injury
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: MDMS
name: Association française des traumatisés crâniens d'Alsace
name: Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation
First posted: 2016-05-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)
timeFrame: from desedation (Day 0) to Day 21.
Secondary outcomes:
measure: Area under the Clinical Features Scale curve
timeFrame: from Day 0 to Day 21.
measure: Mean Analgesia Nociception Index
timeFrame: from Day 0 to Day 21.
measure: Neurological Pupil Index
timeFrame: from Day 0 to Day 21.
measure: Pain (Critical-Care Pain Observation Tool)
timeFrame: from Day 0 to Day 21.
measure: Neurological outcome (Wessex Head Injury Matrix)
timeFrame: from Day 0 to Day 21.
measure: PSH-AM
timeFrame: Six and twelve months
measure: Disability Rating Scale
timeFrame: Six and twelve months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie Réanimation- Hôpital de Hautepierre
Study officials:
References: