Disorder of ConsciousnessSongDoCNCT07209657
Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)
A study testing Live Music Therapy and Recorded Music in people with Disorder of Consciousness and Acquired Brain Injury, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Disorder of Consciousness, Acquired Brain Injury
- What is being tested?
- Live Music Therapy and Recorded Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of a severe ABI, as indicated by at least one of the following:
- Glasgow Coma Scale (GCS) 3-8 at admission to RCH
- Mass pathology evident on neuroimaging
- Expert opinion of treating consultant
- Diagnosis of a DoC, as indicated by at least one of the following:
- Rancho Los Amigos Scale I, II, III or IV
- Expert opinion of treating consultant
- Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.
Who cannot join
- ABI not compatible with life/child expected to die
- ABI resulting from suspected non-accidental causes, including assault/abuse
- Diagnosed premorbid or acquired severe hearing loss
- Inability or unwillingness of legally acceptable representative to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jo Rimmer, MMusThrpay contact
Australia1 site, 1 recruiting
- Recruiting
The Royal Children's Hospital Melbourne
Parkville, Victoria, 3052
Janeen M Bower, PhD, +61 418 244 312, janeen.bower@unimelb.edu.au
Jo Rimmer, MMusThrpy, jo.rimmer@rch.org.au
About this study
Official title: A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)
The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Researchers also want to learn how children respond during music and noise, whether early responses to music are linked to recovery at 6 months, and how parents experience music therapy during their child's hospital stay at The Royal Children's Hospital (RCH) in Melbourne.
Participants will:
Read more
- Take part in a 10-day study period while in hospital. On 8 of the 10 days, they will receive either live or recorded familiar music in random order. Their level of consciousness will be measured before and after each session using a simple behavioural checklist. On the other 2 days, they will take part in video-recorded sessions to compare behavioural responses during live music, recorded music, and white noise. Videos will help capture small changes in movement, eye gaze, or facial expression.
- Have their level of consciousness checked again at 6 months after injury to see if early responses relate to later recovery.
Parents and caregivers will be invited to take part in an interview about their experiences and observations of music therapy with their child.
This study will help researchers understand whether live music therapy provides benefits beyond recorded music and will guide how music therapy is best used to support children and families during recovery from severe brain injury.
Read the detailed description
A disorder of consciousness (DoC) is a common consequence of severe acquired brain injury (ABI) in children. Children may present in coma, unresponsive wakefulness, or a minimally conscious state, and the duration of DoC is strongly linked with long-term recovery. Early, well-designed interventions are important to support emergence to consciousness and improve outcomes.
Music is considered a particularly meaningful stimulus for children because it is familiar, engaging, and closely linked with memory, emotion, and development. Live music therapy may offer additional benefits because the therapist can adjust the music in real time to the child's responses, potentially extending arousal and engagement. Recorded music, however, can be delivered more widely by families or healthcare staff, and may be more scalable. Despite widespread clinical use, especially at The Royal Children's Hospital (RCH) Melbourne, the scientific evidence for music therapy with children in DoC remains limited, and most prior studies have focused on adults.
This parallel mixed-method study has been designed to build robust paediatric-specific evidence through four integrated components:
Within-subject randomised trial (Component 1):
Participants will complete a 10-day data collection period during hospital admission.
On 8 of these days, participants will receive either live music therapy or recorded familiar music, with the order randomised.
Consciousness will be measured before and after each session using a paediatric adaptation of the Simplified Evaluation of Consciousness Disorders (SECONDS).
The objective is to determine whether live therapist-facilitated interventions are more effective than recorded interventions in supporting consciousness recovery.
Multiple baseline case series (Component 2):
On 2 of the 10 days, participants will take part in video-recorded sessions comparing responses during live music, recorded music, and white noise.
Behavioural responses (such as gaze, facial expression, and movement) will be coded to capture subtle and immediate changes that may not last long enough to appear in pre-post measures.
This component provides a mechanistic understanding of how children respond during auditory stimulation.
Six-month follow-up assessment (Component 3):
At 6 months post-injury, participants' level of consciousness will be reassessed in person or via telehealth.
This assessment will test whether early responsiveness to music interventions or behavioural responses during sessions are linked with longer-term recovery.
Parent and caregiver interviews (Component 4):
Parents and caregivers will be invited to take part in semi-structured interviews about their observations and experiences of music therapy during their child's admission.
Data will be analysed thematically to ensure family perspectives are embedded in the design of future clinical interventions.
Expected outcomes:
This study will provide the first controlled paediatric data comparing live and recorded music therapy in DoC. It will show whether live interventions provide unique benefits, whether early responsiveness predicts recovery, and how families experience music therapy during a critical stage of hospitalisation. Results will have immediate clinical translation by guiding how music interventions are best delivered and resourced, potentially supporting faster emergence to consciousness, shorter hospital stays, and improved wellbeing for children and their families.
- Conditions
- Disorder of Consciousness, Acquired Brain Injury
- Being tested
- Live Music Therapy, Recorded Music
- Keywords
- music therapy, music, paediatric disorder of consciousness
- Medical subject headings
- Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Music TherapyBehavioural
The recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music intervention and will present the recorded music via iPad and small portable speaker.
Recorded MusicBehavioural
The recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music intervention and will present the recorded music via iPad and small portable speaker.
| Study group | Role | What they receive |
|---|---|---|
| Live music therapy intervention | Experimental | Live music therapy sessions will be delivered by an experienced music therapist using familiar songs with guitar accompaniment. Musical elements may be adapted in real time in response to the child's behaviours to support engagement. Each session will last about 20 minutes, tailored to the child's reduced state of consciousness and to minimise overstimulation or fatigue. Receives: Behavioral: Live Music Therapy |
| Recorded music intervention | Experimental | Recorded music interventions will use commercially available recordings of the same familiar songs presented in the live sessions, with only the format differing. The same music therapist will remain present in the room and play the recordings through an iPad and portable speaker. Receives: Behavioral: Recorded Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)'
The Simplified Evaluation of Consciousness Disorders (SECONDS) is an 8-item behavioural scale assessing responsiveness across the spectrum of disorders of consciousness (DoC). Items progress in complexity from arousal response (1) to functional communication (8). The SECONDS is adapted from the Coma Recovery Scale-Revised but is faster to administer, making it suitable in acute paediatric settings. It has strong validity and inter-rater reliability in diagnosing prolonged DoC. For this trial, child-friendly modifications are used (e.g., age-appropriate toys, picture books, and yes/no questions) to ensure suitability for children.
Measured: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury
Secondary outcomes (1)
Changes in the 'Music interventions in paediatric DoC observation record (MBR)' outcomes across live music, recorded music, and control noise condition
The Music Behavioural Response Checklist (MBR) records behavioural responses during music interventions in children with disorders of consciousness (DoC). It has two sections: (1) arousal, capturing 13 discrete movement categories, and (2) awareness, capturing 15 categories of more complex behaviours linked to minimally conscious states and emergence. The MBR was developed and validated at the Royal Children's Hospital, showing content validity and fair to substantial inter-rater reliability. It is completed from video recordings to ensure subtle and idiosyncratic behaviours are captured.
Measured: Days 3 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study startSep 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single site, parallel mixed method incorporating a within subject design (trial).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janeen M Bower, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209657
- Sponsor's protocol ID
- 113687
- Acronym
- SongDoC
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pending extended consent from the participant's legal guardian, de-identified Individual Participant Data (IPD) will be made available for long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.
Publications
Molteni E, Canas LDS, Briand MM, Estraneo A, Font CC, Formisano R, Fufaeva E, Gosseries O, Howarth RA, Lanteri P, Licandro GI, Magee WL, Veeramuthu V, Wilson P, Yamaki T, Slomine BS; as the Special Interest Group on DoC of the International Brain Injury Association (IBIA-DoC SIG). Scoping Review on the Diagnosis, Prognosis, and Treatment of Pediatric Disorders of Consciousness. Neurology. 2023 Aug 8;101(6):e581-e593. doi: 10.1212/WNL.0000000000207473. Epub 2023 Jun 12.
PubMed 37308301Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28.
PubMed 32992025Bower J, Magee WL, Catroppa C, Baker FA. Content Validity and Inter-rater Reliability of the Music Interventions in Pediatric DoC Behavior Observation Record. J Music Ther. 2023 May 5;60(1):13-35. doi: 10.1093/jmt/thac013.
PubMed 36197798
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)
- ClinicalTrials.gov ID
- NCT07209657
- Acronym / sponsor ID
- SongDoC / 113687
- Conditions
- Disorder of Consciousness, Acquired Brain Injury
- Keywords
- music therapy, music, paediatric disorder of consciousness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- 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.
The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Researchers also want to learn how children respond during music and noise, whether early responses to music are linked to recovery at 6 months, and how parents experience music therapy during their child's hospital stay at The Royal Children's Hospital (RCH) in Melbourne.
Participants will:
- Take part in a 10-day study period while in hospital. On 8 of the 10 days, they will receive either live or recorded familiar music in random order. Their level of consciousness will be measured before and after each session using a simple behavioural checklist. On the other 2 days, they will take part in video-recorded sessions to compare behavioural responses during live music, recorded music, and white noise. Videos will help capture small changes in movement, eye gaze, or facial expression.
- Have their level of consciousness checked again at 6 months after injury to see if early responses relate to later recovery.
Parents and caregivers will be invited to take part in an interview about their experiences and observations of music therapy with their child.
This study will help researchers understand whether live music therapy provides benefits beyond recorded music and will guide how music therapy is best used to support children and families during recovery from severe brain injury.
Detailed description
A disorder of consciousness (DoC) is a common consequence of severe acquired brain injury (ABI) in children. Children may present in coma, unresponsive wakefulness, or a minimally conscious state, and the duration of DoC is strongly linked with long-term recovery. Early, well-designed interventions are important to support emergence to consciousness and improve outcomes.
Music is considered a particularly meaningful stimulus for children because it is familiar, engaging, and closely linked with memory, emotion, and development. Live music therapy may offer additional benefits because the therapist can adjust the music in real time to the child's responses, potentially extending arousal and engagement. Recorded music, however, can be delivered more widely by families or healthcare staff, and may be more scalable. Despite widespread clinical use, especially at The Royal Children's Hospital (RCH) Melbourne, the scientific evidence for music therapy with children in DoC remains limited, and most prior studies have focused on adults.
This parallel mixed-method study has been designed to build robust paediatric-specific evidence through four integrated components:
Within-subject randomised trial (Component 1):
Participants will complete a 10-day data collection period during hospital admission.
On 8 of these days, participants will receive either live music therapy or recorded familiar music, with the order randomised.
Consciousness will be measured before and after each session using a paediatric adaptation of the Simplified Evaluation of Consciousness Disorders (SECONDS).
The objective is to determine whether live therapist-facilitated interventions are more effective than recorded interventions in supporting consciousness recovery.
Multiple baseline case series (Component 2):
On 2 of the 10 days, participants will take part in video-recorded sessions comparing responses during live music, recorded music, and white noise.
Behavioural responses (such as gaze, facial expression, and movement) will be coded to capture subtle and immediate changes that may not last long enough to appear in pre-post measures.
This component provides a mechanistic understanding of how children respond during auditory stimulation.
Six-month follow-up assessment (Component 3):
At 6 months post-injury, participants' level of consciousness will be reassessed in person or via telehealth.
This assessment will test whether early responsiveness to music interventions or behavioural responses during sessions are linked with longer-term recovery.
Parent and caregiver interviews (Component 4):
Parents and caregivers will be invited to take part in semi-structured interviews about their observations and experiences of music therapy during their child's admission.
Data will be analysed thematically to ensure family perspectives are embedded in the design of future clinical interventions.
Expected outcomes:
This study will provide the first controlled paediatric data comparing live and recorded music therapy in DoC. It will show whether live interventions provide unique benefits, whether early responsiveness predicts recovery, and how families experience music therapy during a critical stage of hospitalisation. Results will have immediate clinical translation by guiding how music interventions are best delivered and resourced, potentially supporting faster emergence to consciousness, shorter hospital stays, and improved wellbeing for children and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single site, parallel mixed method incorporating a within subject design (trial).
| Arm | Type | Receives |
|---|---|---|
| Live music therapy intervention | Experimental | Behavioral: Live Music TherapyLive music therapy sessions will be delivered by an experienced music therapist using familiar songs with guitar accompaniment. Musical elements may be adapted in real time in response to the child's behaviours to support engagement. Each session will last about 20 minutes, tailored to the child's reduced state of consciousness and to minimise overstimulation or fatigue. |
| Recorded music intervention | Experimental | Behavioral: Recorded MusicRecorded music interventions will use commercially available recordings of the same familiar songs presented in the live sessions, with only the format differing. The same music therapist will remain present in the room and play the recordings through an iPad and portable speaker. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of a severe ABI, as indicated by at least one of the following:
- Diagnosis of a DoC, as indicated by at least one of the following:
- Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.
Key exclusion criteria (4 listed)
- ABI not compatible with life/child expected to die
- ABI resulting from suspected non-accidental causes, including assault/abuse
- Diagnosed premorbid or acquired severe hearing loss
- Inability or unwillingness of legally acceptable representative to give written informed consent
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 |
|---|---|---|
| Live Music TherapyThe recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music intervention and will present the recorded music via iPad and small portable speaker. | Behavioural | Live music therapy intervention |
| Recorded MusicThe recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music intervention and will present the recorded music via iPad and small portable speaker. | Behavioural | Recorded music intervention |
Primary outcome
Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)'
Time frame: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury
The Simplified Evaluation of Consciousness Disorders (SECONDS) is an 8-item behavioural scale assessing responsiveness across the spectrum of disorders of consciousness (DoC). Items progress in complexity from arousal response (1) to functional communication (8). The SECONDS is adapted from the Coma Recovery Scale-Revised but is faster to administer, making it suitable in acute paediatric settings. It has strong validity and inter-rater reliability in diagnosing prolonged DoC. For this trial, child-friendly modifications are used (e.g., age-appropriate toys, picture books, and yes/no questions) to ensure suitability for children.
1 secondary outcome
Changes in the 'Music interventions in paediatric DoC observation record (MBR)' outcomes across live music, recorded music, and control noise condition
Time frame: Days 3 and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 37308301Molteni E, Canas LDS, Briand MM, Estraneo A, Font CC, Formisano R, Fufaeva E, Gosseries O, Howarth RA, Lanteri P, Licandro GI, Magee WL, Veeramuthu V, Wilson P, Yamaki T, Slomine BS; as the Special Interest Group on DoC of the International Brain Injury Association (IBIA-DoC SIG). Scoping Review on the Diagnosis, Prognosis, and Treatment of Pediatric Disorders of Consciousness. Neurology. 2023 Aug 8;101(6):e581-e593. doi: 10.1212/WNL.0000000000207473. Epub 2023 Jun 12.
- Background: PubMed 32992025Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28.
- Background: PubMed 36197798Bower J, Magee WL, Catroppa C, Baker FA. Content Validity and Inter-rater Reliability of the Music Interventions in Pediatric DoC Behavior Observation Record. J Music Ther. 2023 May 5;60(1):13-35. doi: 10.1093/jmt/thac013.
- Individual participant dataSharing planned: Yes. Pending extended consent from the participant's legal guardian, de-identified Individual Participant Data (IPD) will be made available for long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
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.
Jo Rimmer, MMusThrpay contact
Janeen M Bower, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Music Therapy and Recorded Music in people with Disorder of Consciousness and Acquired Brain Injury, run by Murdoch Childrens Research Institute at 1 site in Australia.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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 Australia. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janeen M Bower, PhD (+61 418 244 312, janeen.bower@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)' (time frame: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07209657, which also lists 3 linked publications.
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 2 Sep 2026.