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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02783105

Acronym

MUSIC-TCNV

Enrollment

Registered

2016-05-26

Start date

2016-11-20

Completion date

2019-12-18

Last updated

2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Sympathetic Hyperactivity

Keywords

Music therapy, Paroxysmal sympathetic hyperactivity, Traumatic brain injury

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.

Interventions

OTHERMusical intervention

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)	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)

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026