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

Paroxysmal Sympathetic Hyperactivity Clinical Trial

— MUSIC-TCNV  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02783105
• Other study ID #: 6224
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2016
• Est. completion date: December 18, 2019

Study information

• Verified date: November 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 18, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hyperkinesis
• Paroxysmal Sympathetic Hyperactivity

Intervention

Other:
• Musical intervention

• 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

Locations

Country	Name	City	State
France	Service d'Anesthésie Réanimation- Hôpital de Hautepierre	Strasbourg

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

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