Paroxysmal Sympathetic HyperactivityMUSIC-TCNVNCT02783105
Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury
A study testing Musical intervention in people with Paroxysmal Sympathetic Hyperactivity, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paroxysmal Sympathetic Hyperactivity
- What is being tested?
- Musical intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2016to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie Réanimation- Hôpital de Hautepierre
Strasbourg, 67098
About this study
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.
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.
Read more
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.
- Conditions
- Paroxysmal Sympathetic Hyperactivity
- Being tested
- Musical intervention, Control
- Keywords
- Music therapy, Paroxysmal sympathetic hyperactivity, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical interventionOther
ControlOther
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 group | Role | What they receive |
|---|---|---|
| Musical intervention | Experimental | 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. Receives: Other: Musical intervention |
| Control | Sham comparator | 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from desedation (Day 0) to Day 21.
Secondary outcomes (7)
Area under the Clinical Features Scale curve
Measured: from Day 0 to Day 21.
Mean Analgesia Nociception Index
Measured: from Day 0 to Day 21.
Neurological Pupil Index
Measured: from Day 0 to Day 21.
Pain (Critical-Care Pain Observation Tool)
Measured: from Day 0 to Day 21.
Neurological outcome (Wessex Head Injury Matrix)
Measured: from Day 0 to Day 21.
PSH-AM
Measured: Six and twelve months
Disability Rating Scale
Measured: Six and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start20 Nov 2016
- Primary completion4 Jan 2019
- Study completion18 Dec 2019
Why it stopped: inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Sympathetic HyperactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, MDMS, Association française des traumatisés crâniens d'Alsace, Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783105
- Sponsor's protocol ID
- 6224
- Acronym
- MUSIC-TCNV
- Status last verified
- Nov 2016
- First submitted
- 23 May 2016
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02783105
- Acronym / sponsor ID
- MUSIC-TCNV / 6224
- Conditions
- Paroxysmal Sympathetic Hyperactivity
- Keywords
- Music therapy, Paroxysmal sympathetic hyperactivity, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Fondation Apicil, MDMS, Association française des traumatisés crâniens d'Alsace, Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Musical intervention | Experimental | Other: Musical interventionMusic 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. |
| Control | Sham comparator | Other: ControlPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical intervention | Other | Musical intervention |
| ControlPatients 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 |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical intervention in people with Paroxysmal Sympathetic Hyperactivity, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29) (time frame: from desedation (Day 0) to Day 21.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.