Cranioplasty Cognitive Outcome Study

NCT03791996 | Unknown

• 1 other identifier: CCO-RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Impairment; Brain Herniation

Keywords

Cranioplasty; Craniectomy; Cognitive impairment; Syndrome of the trephined

Outcome Measures

Primary Outcomes (3)

• Montreal Cognitive Assessment (MOCA)

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

  3-months

• 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.

  3-months

• Rivermead Behavioural Memory Test (RBMT)

  3-months

Secondary Outcomes (7)

• Motor assessment

  3-months

• Modified Functional Ambulation Category (MFAC)

  3-months

• Quality of life assessment

  3-months

• Psychological assessment

  3-months

• Caregiver assessment

  3-months

Study Arms (2)

"Late" cranioplasty

NO INTERVENTION

Subjects undergoing cranioplasty within 3 months after craniectomy.

"Early" cranioplasty

EXPERIMENTAL

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Procedure: "Early" cranioplasty

Interventions

"Early" cranioplasty PROCEDURE

Subjects undergoing cranioplasty beyond 3 months after craniectomy.

"Early" cranioplasty

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kwong Wah Hospital: lead
• The Queen Elizabeth Hospital: collaborator
• Queen Mary Hospital, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Princess Margaret Hospital, Canada: collaborator
• Tuen Mun Hospital: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (1)

Kwong Wah Hospital

Hong Kong, Hong Kong, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 28368505 BACKGROUND

• 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.

  PMID: 23662672 RESULT

• 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.

  PMID: 27489166 RESULT

• 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.

  PMID: 27499122 RESULT

• 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.

  PMID: 26056810 RESULT

• 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.

  PMID: 25827865 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Calvin Mak, MBBS FRCS

  Neurosurgery, Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Mak, MBBS FRCS

CONTACT

35066026; mhk349@ha.org.hk

Marina Lee

CONTACT

35066026; leeymm@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 1:1 block central randomisation with assignments written on a card sealed in an opaque envelop.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 3, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)