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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Paroxysmal Sympathetic Hyperactivity

Treatments: Other: Control; Other: Musical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02783105

6224

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Musical intervention

Experimental group

Description:

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.

Treatment:

Other: Musical intervention

Control

Sham Comparator group

Description:

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

Treatment:

Other: Control