Traumatic Brain InjuryNCT07122752
Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy
An observational study of Traumatic Brain Injury and Acquired Brain Injury, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acquired Brain Injury, Brain Tumor
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jul 2025to 29 Aug 2027
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NA as no patient is recruited for this study as the outcomes involve retrospective data as part of a clinical service audit.
Who may be able to join
- Unilateral decompressive craniectomy (DC)
- Acute Stroke or traumatic brain injury
- >30 days post DC
- Healed surgical wounds, non-bulging flaps
- Presence of caregiver supervision
Who cannot join
- Vegetative or minimally responsive state
- Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
- Life expectancy < 6 months
- Unhealed or infected post-DC neurosurgical wounds
- Known allergy to investigational products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis (PEACO) After Decompression Craniectomy in Clinical Settings: A Retrospective Comparison Study of Monitored Versus Unmonitored Protocols
This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.
Read the detailed description
The study aims to:
- Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
- Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury, Brain Tumor, Stroke
- Keywords
- Cranial Orthosis, 3D Printing, Decompression Craniectomy, Retrospective Study, Head Protection Device, Monitored Protocol, Unmonitored Protocol
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Brain Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Version 1 Head protection Device 2021 | Version 2 Head protection device 2025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (safety and tolerability)
The therapist will assess patient in terms of pain, redness, skin imprints and pruritus' on patient's skin after wearing the cranial cap. This is to allow the understanding of the incidence of the treatment-emergent adverse events (safety and tolerability).
Measured: 30 minutes post fitting (version 1 and 2)
Patient Reported Outcome Measures (PROMS) PROMs (compliance)
The patient will be sent a questionnaire. The question relating to compliance is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Measured: 2023-2025
Patient Reported Outcome Measures (PROMS) PROMs (wearing time)
The patient will be sent a questionnaire. The question relating to wearing time is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Measured: 2023-2025
Patient Reported Outcome Measures (PROMS) PROMs (adverse events)
The patient will be sent a questionnaire. The question relating to adverse event is "Did you experience any of the following after two hours of wear? This will allow team to assess feasibility, safety and clinical outcomes.
Measured: 2023-2025
Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)
The patient will be sent a questionnaire. The question relating to cosmesis rating is "Please rate the appearance of your cranial cap". This will allow team to assess feasibility, safety and clinical outcomes.
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start29 Jul 2025
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chua Sui Geok, Karen, Tan Tock Seng Hospital
- Investigators
- Dr Karen Chua, MBBS, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122752
- Sponsor's protocol ID
- DSRB 2025/1218
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no new IP generated
Publications
Chua KSG, Krishnan RR, Yen JM, Plunkett TK, Soh YM, Lim CJ, Chia CM, Looi JC, Ng SG, Rao J. 3D-printed external cranial protection following decompressive craniectomy after brain injury: A pilot feasibility cohort study. PLoS One. 2021 Oct 28;16(10):e0258296. doi: 10.1371/journal.pone.0258296. eCollection 2021.
PubMed 34710123Fernandez LL, Rodriguez D, Griswold DP, Khun I, Aristizabal S, Aristizabal JH, Richards G, Pavek A, Jayaraman S. Innovative External Cranial Devices for Protecting a Craniectomy Site: A Scoping Review on Noninvasive Approaches for Patients Awaiting Cranioplasty. Neurosurgery. 2025 Apr 1;96(4):713-724. doi: 10.1227/neu.0000000000003157. Epub 2024 Sep 9.
PubMed 39248525Ma S, Li C, Gu Y, Chen Y, Li X, Wang Q, Xu H. Application of a 3D printed wig protection device after decompressive craniectomy. Sci Rep. 2025 Mar 19;15(1):9545. doi: 10.1038/s41598-025-94246-0.
PubMed 40108252Chua KSG, Shankar R, Yam MGJ, Yee E, Ratha Krishnan R, Plunkett TK, Chong WB, Low JAM, Said NHB, Chao J, Ng SG, Rao JP. Preliminary Feasibility Implementation of Post-Decompressive Craniectomy 3D-Printed Externally Applied Cranial Orthosis (PEACO) During Inpatient Rehabilitation: A Retrospective Cohort Study Reporting Short-Term Tolerability and Patient/Caregiver-Reported Feedback. Healthcare (Basel). 2026 Oct 9;14(20):3361. doi: 10.3390/healthcare14203361.
PubMed 42940406
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis (PEACO) After Decompression Craniectomy in Clinical Settings: A Retrospective Comparison Study of Monitored Versus Unmonitored Protocols
- ClinicalTrials.gov ID
- NCT07122752
- Acronym / sponsor ID
- DSRB 2025/1218
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury, Brain Tumor, Stroke
- Keywords
- Cranial Orthosis, 3D Printing, Decompression Craniectomy, Retrospective Study, Head Protection Device, Monitored Protocol, Unmonitored Protocol
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 14 Aug 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.
This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.
Detailed description
The study aims to:
- Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
- Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Version 1 Head protection Device 2021 | – | –Version 2 Head protection device 2025 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NA as no patient is recruited for this study as the outcomes involve retrospective data as part of a clinical service audit.
Key inclusion criteria (5 listed)
- Unilateral decompressive craniectomy (DC)
- Acute Stroke or traumatic brain injury
- >30 days post DC
- Healed surgical wounds, non-bulging flaps
- Presence of caregiver supervision
Key exclusion criteria (5 listed)
- Vegetative or minimally responsive state
- Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
- Life expectancy < 6 months
- Unhealed or infected post-DC neurosurgical wounds
- Known allergy to investigational products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment-emergent adverse events (safety and tolerability)
Time frame: 30 minutes post fitting (version 1 and 2)
The therapist will assess patient in terms of pain, redness, skin imprints and pruritus' on patient's skin after wearing the cranial cap. This is to allow the understanding of the incidence of the treatment-emergent adverse events (safety and tolerability).
Patient Reported Outcome Measures (PROMS) PROMs (compliance)
Time frame: 2023-2025
The patient will be sent a questionnaire. The question relating to compliance is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (wearing time)
Time frame: 2023-2025
The patient will be sent a questionnaire. The question relating to wearing time is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (adverse events)
Time frame: 2023-2025
The patient will be sent a questionnaire. The question relating to adverse event is "Did you experience any of the following after two hours of wear? This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)
Time frame: 2023-2025
The patient will be sent a questionnaire. The question relating to cosmesis rating is "Please rate the appearance of your cranial cap". This will allow team to assess feasibility, safety and clinical outcomes.
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 8 Oct 2026.
- Background: PubMed 34710123Chua KSG, Krishnan RR, Yen JM, Plunkett TK, Soh YM, Lim CJ, Chia CM, Looi JC, Ng SG, Rao J. 3D-printed external cranial protection following decompressive craniectomy after brain injury: A pilot feasibility cohort study. PLoS One. 2021 Oct 28;16(10):e0258296. doi: 10.1371/journal.pone.0258296. eCollection 2021.
- Background: PubMed 39248525Fernandez LL, Rodriguez D, Griswold DP, Khun I, Aristizabal S, Aristizabal JH, Richards G, Pavek A, Jayaraman S. Innovative External Cranial Devices for Protecting a Craniectomy Site: A Scoping Review on Noninvasive Approaches for Patients Awaiting Cranioplasty. Neurosurgery. 2025 Apr 1;96(4):713-724. doi: 10.1227/neu.0000000000003157. Epub 2024 Sep 9.
- Background: PubMed 40108252Ma S, Li C, Gu Y, Chen Y, Li X, Wang Q, Xu H. Application of a 3D printed wig protection device after decompressive craniectomy. Sci Rep. 2025 Mar 19;15(1):9545. doi: 10.1038/s41598-025-94246-0.
- Derived from this study: PubMed 42940406Chua KSG, Shankar R, Yam MGJ, Yee E, Ratha Krishnan R, Plunkett TK, Chong WB, Low JAM, Said NHB, Chao J, Ng SG, Rao JP. Preliminary Feasibility Implementation of Post-Decompressive Craniectomy 3D-Printed Externally Applied Cranial Orthosis (PEACO) During Inpatient Rehabilitation: A Retrospective Cohort Study Reporting Short-Term Tolerability and Patient/Caregiver-Reported Feedback. Healthcare (Basel). 2026 Oct 9;14(20):3361. doi: 10.3390/healthcare14203361.
- Individual participant dataSharing planned: No. no new IP generated
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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.
Dr Karen Chua, MBBS principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Acquired Brain Injury, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 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 Singapore. 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?
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?
Treatment-emergent adverse events (safety and tolerability) (time frame: 30 minutes post fitting (version 1 and 2)). The study lists 5 primary outcomes in all. 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 NCT07122752, which also lists 4 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 8 Oct 2026.