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

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ClinicalTrials.gov Identifier: NCT02783105
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
Fondation Apicil
MDMS
Association française des traumatisés crâniens d'Alsace
Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Paroxysmal Sympathetic Hyperactivity Other: Musical intervention Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29) [ Time Frame: 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 Outcome Measures :
  1. Area under the Clinical Features Scale curve [ Time Frame: from Day 0 to Day 21. ]
  2. Mean Analgesia Nociception Index [ Time Frame: from Day 0 to Day 21. ]
  3. Neurological Pupil Index [ Time Frame: from Day 0 to Day 21. ]
  4. Pain (Critical-Care Pain Observation Tool) [ Time Frame: from Day 0 to Day 21. ]
  5. Neurological outcome (Wessex Head Injury Matrix) [ Time Frame: from Day 0 to Day 21. ]
  6. PSH-AM [ Time Frame: Six and twelve months ]
  7. Disability Rating Scale [ Time Frame: Six and twelve months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783105


Contacts
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Contact: Julien POTTECHER, MD PhD 03 88 12 70 95 julien.pottecher@chru-strasbourg.fr

Locations
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France
Service d'Anesthésie Réanimation- Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Principal Investigator: Julien POTTECHER, MD PhD         
Sub-Investigator: Pierre Auguste DIEMUNSCH, MD PhD         
Sub-Investigator: Hortense BESANCENOT, MD         
Sub-Investigator: Aude RUIMY, MD         
Sub-Investigator: Guy FREYS, MD         
Sub-Investigator: Magdalena SZCZOT, MD         
Sub-Investigator: Anne LAUNOY, MD         
Sub-Investigator: Nadia DHIF, MD         
Sub-Investigator: Alain MEYER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Fondation Apicil
MDMS
Association française des traumatisés crâniens d'Alsace
Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02783105     History of Changes
Other Study ID Numbers: 6224
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
Music therapy
Paroxysmal sympathetic hyperactivity
Traumatic brain injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hyperkinesis
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms