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 |
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Recruitment Status :
Terminated
(inclusion difficulties)
First Posted : May 26, 2016
Last Update Posted : November 17, 2021
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 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. |
| Actual Study Start Date : | November 20, 2016 |
| Actual Primary Completion Date : | January 4, 2019 |
| Actual Study Completion Date : | December 18, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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
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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 |
- 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)
- Area under the Clinical Features Scale curve [ Time Frame: from Day 0 to Day 21. ]
- Mean Analgesia Nociception Index [ Time Frame: from Day 0 to Day 21. ]
- Neurological Pupil Index [ Time Frame: from Day 0 to Day 21. ]
- Pain (Critical-Care Pain Observation Tool) [ Time Frame: from Day 0 to Day 21. ]
- Neurological outcome (Wessex Head Injury Matrix) [ Time Frame: from Day 0 to Day 21. ]
- PSH-AM [ Time Frame: Six and twelve months ]
- 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 |
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
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
| France | |
| Service d'Anesthésie Réanimation- Hôpital de Hautepierre | |
| Strasbourg, France, 67098 | |
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT02783105 |
| Other Study ID Numbers: |
6224 |
| First Posted: | May 26, 2016 Key Record Dates |
| Last Update Posted: | November 17, 2021 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Music therapy Paroxysmal sympathetic hyperactivity Traumatic brain injury |
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Brain Injuries Brain Injuries, Traumatic Hyperkinesis Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Dyskinesias Neurologic Manifestations |