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Cognitive ImpairmentNCT03791996

Cranioplasty Cognitive Outcome Study

A study testing "Early" cranioplasty in people with Cognitive Impairment and Brain Herniation, run by Kwong Wah Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This will be a multicenter prospective randomized study of adult patients with an acquired skull defect as a result of craniectomy and considered suitable for cranioplasty, i.e. reconstruction of the skull defect, at all seven Hong Kong Hospital Authority neurosurgical units. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Cognitive Impairment, Brain Herniation
What is being tested?
"Early" cranioplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Mar 2019to 1 Mar 2021
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal to 18 years-old,
  • Craniectomy was performed due to head injury, infarct or spontaneous intracerebral hemorrhage, and benign tumors.
  • Craniectomy skull defect size of >10cm at its longest diameter
  • Craniectomy performed at any of the Hospital Authority's Neurosurgical Centers after 1st March 2019

Who cannot join

  • Age older than 80 years-old,
  • Patients cannot communicate by obeying simple command,
  • Patients who are unfit for cranioplasty as decided by the treating neurosurgeon
  • Posterior fossa craniectomy
  • Craniectomy performed before 1st March 2019
  • Craniectomy performed at an institution outside the Hospital Authority
Show all 12Show fewer
  • Any pre-existing illness that renders the patient moderately or severely disabled before the brain insult.
  • Patients that need an additional procedure e.g. cerebrospinal fluid shunting with cranioplasty in the same setting.
  • History of central nervous system infection
  • Craniectomy-related complications such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect patient's long-term cognitive outcome
  • Claustrophobia or any other medical condition that prohibits the patient from undergo MRI scanning
  • Patients who cannot understand spoken English or Chinese

Trial locations and contacts

1 site in 1 country.

Calvin Mak, MBBS FRCS contact

35066026

mhk349@ha.org.hk

Marina Lee contact

35066026

leeymm@ha.org.hk

China1 site, 1 recruiting

  • Kwong Wah Hospital

    Hong Kong, Hong Kong

    Peter YM Woo, FRCS (SN), 852+ 3517 2275 ext. 2275, peterymwoo@gmail.com

    Peter YM Woo, FRCS (SN)

    Recruiting

Other trials in China

About this study

Official title: Impact of Cranioplasty on Cognitive Outcome: A Multi-Center Prospective Randomized Study

This will be a multicenter prospective randomized study of adult patients with an acquired skull defect as a result of craniectomy and considered suitable for cranioplasty, i.e. reconstruction of the skull defect, at all seven Hong Kong Hospital Authority neurosurgical units. Patients that underwent their primary craniectomy operation at any of the Hospital Authority neurosurgery centers from the 1st March 2019 and considered suitable for cranioplasty will be included in this study. Those who underwent their primary craniectomy before 1st March 2019 or at an institution other than the aforementioned neurosurgical units will be excluded. Data from clinical records, operation notes, medication-dispensing records, laboratory records and radiological reports will be collected.

30 adult patients with craniectomy will be recruited and randomized into two groups: "early" cranioplasty, i.e. performed within 3 months of craniectomy, and "late", i.e. cranioplasty performed more than 3 months after the operation. The aim of the study is to determine whether early cranioplasty can improve on patient's cognitive performance compared to those who undergo the procedure after 3 months.

Read the detailed description

Decompressive craniectomy, a neurosurgical procedure where a portion of the skull calvarium is removed, is a life-saving procedure. The complication rate of cranioplasty, a neurosurgical procedure where the acquired skull defect is reconstructed, ranges from 11% to 26% and includes postoperative hemorrhage and infection. (4) The syndrome of the trephined is a recognized long-term complication in which certain groups of patients, experience debilitating neurocognitive deficits in addition to chronic headache, dizziness, fatigability and clinical depression. (2) It is believed that the lack of an overlying bone may cause undue significant atmospheric pressure on the underlying cortex, thereby reducing cerebral perfusion and cerebrospinal fluid flow. There are reports that cognitive improvement can be observed in up to 30% of patients after cranioplasty yet the underlying mechanism for this observation is unclear. (1) Some studies have demonstrated enhanced cerebral perfusion by non-invasive investigations, but there is a lack of large scale systematically performed studies to verify such cerebral hemodynamic effects. (1-3) Clinical equipoise exists regarding the optimum timing of cranioplasty procedures after craniectomies. While the anecdotal practice of delaying cranioplasty for at least 3 months after a craniectomy is common, local and overseas observational studies suggest that performing early cranioplasties (i.e. within 3 months) is equally safe in terms of infection and other operative complications. (4-6)

Being tested
"Early" cranioplasty
Keywords
Cranioplasty, Craniectomy, Cognitive impairment, Syndrome of the trephined
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Early" cranioplastyProcedure or surgery

    Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Study groups in NCT03791996
Study groupRoleWhat they receive
"Late" cranioplastyNo interventionSubjects undergoing cranioplasty within 3 months after craniectomy.
"Early" cranioplastyExperimentalSubjects undergoing cranioplasty beyond 3 months after craniectomy.
Receives: Procedure: "Early" cranioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MOCA)

    Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.

    Measured: 3-months

  2. Neurobehavioural Cognitive State Examination (NCSE)

    Multi-domain assessment involving: orientation, attention, registration, comprehension, repetition, naming, construction, calculation, similarities,judgement. Stratification of each domain into mild, moderate and severe impairment. The higher the number the better the outcome.

    Measured: 3-months

  3. Rivermead Behavioural Memory Test (RBMT)

    Measured: 3-months

Secondary outcomes (7)

  1. Motor assessment

    Medical Research Council limb power

    Measured: 3-months

  2. Modified Functional Ambulation Category (MFAC)

    7 ordinal scale assessment. The lower the scale, the worse the ambulatory ability of the patient. I: bed bound; 2: wheel-chair bound; 3: dependent walker; 4: Assisted walker; 5: Supervised walker; 6: Indoor walker; 7: Outdoor walker (patient can walk anywhere).

    Measured: 3-months

  3. Quality of life assessment

    Short Form-36 (SF-36)

    Measured: 3-months

  4. Psychological assessment

    Beck depression inventory (BDI)

    Measured: 3-months

  5. Caregiver assessment

    Caregiver Strain Index

    Measured: 3-months

  6. Caregiver

    Caregiver self-assessment questionnaire

    Measured: 3-months

  7. MRI cerebral perfusion assessment

    Cerebral blood flow

    Measured: 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Sep 2020 (estimated)
  4. Study completion1 Mar 2021 (estimated)

Resources

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
2-arm randomised study with subjects centrally randomised by assigning them into either the control "late" cranioplasty group or the intervention "early" cranioplasty group. All subjects will eventually receive the cranioplasty procedure.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791996
Sponsor's protocol ID
CCO-RCT
Status last verified
Oct 2019
First submitted
30 Dec 2018
Last updated
17 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Halani SH, Chu JK, Malcolm JG, Rindler RS, Allen JW, Grossberg JA, Pradilla G, Ahmad FU. Effects of Cranioplasty on Cerebral Blood Flow Following Decompressive Craniectomy: A Systematic Review of the Literature. Neurosurgery. 2017 Aug 1;81(2):204-216. doi: 10.1093/neuros/nyx054.

    PubMed 28368505

  • Bender A, Heulin S, Rohrer S, Mehrkens JH, Heidecke V, Straube A, Pfefferkorn T. Early cranioplasty may improve outcome in neurological patients with decompressive craniectomy. Brain Inj. 2013;27(9):1073-9. doi: 10.3109/02699052.2013.794972. Epub 2013 May 10.

    PubMed 23662672

  • Ashayeri K, M Jackson E, Huang J, Brem H, Gordon CR. Syndrome of the Trephined: A Systematic Review. Neurosurgery. 2016 Oct;79(4):525-34. doi: 10.1227/NEU.0000000000001366.

    PubMed 27489166

  • Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.

    PubMed 27499122

  • Xu H, Niu C, Fu X, Ding W, Ling S, Jiang X, Ji Y. Early cranioplasty vs. late cranioplasty for the treatment of cranial defect: A systematic review. Clin Neurol Neurosurg. 2015 Sep;136:33-40. doi: 10.1016/j.clineuro.2015.05.031. Epub 2015 May 29.

    PubMed 26056810

  • Tsang AC, Hui VK, Lui WM, Leung GK. Complications of post-craniectomy cranioplasty: risk factor analysis and implications for treatment planning. J Clin Neurosci. 2015 May;22(5):834-7. doi: 10.1016/j.jocn.2014.11.021. Epub 2015 Mar 28.

    PubMed 25827865

Questions about this trial

What is this clinical trial studying?

A study testing "Early" cranioplasty in people with Cognitive Impairment and Brain Herniation, run by Kwong Wah Hospital at 1 site in China.

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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Calvin Mak, MBBS FRCS (35066026, mhk349@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MOCA) (time frame: 3-months). The study lists 3 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 NCT03791996, which also lists 6 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 17 Oct 2019.

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Cranioplasty Cognitive Outcome Study (NCT03791996) | AzTrials