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Cranioplasty Cognitive Outcome Study

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ClinicalTrials.gov Identifier: NCT03791996
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
Queen Elizabeth Hospital
Queen Mary Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Princess Margaret Hospital, Canada
Tuen Mun Hospital
Pamela Youde Nethersole Eastern Hospital
Information provided by (Responsible Party):
Peter Woo Yat Ming, Kwong Wah Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2018
First Posted Date  ICMJE January 3, 2019
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Montreal Cognitive Assessment (MOCA) [ Time Frame: 3-months ]
    Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.
  • Neurobehavioural Cognitive State Examination (NCSE) [ Time Frame: 3-months ]
    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.
  • Rivermead Behavioural Memory Test (RBMT) [ Time Frame: 3-months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2018)
  • Cognitive performance [ Time Frame: 3-months ]
    Montreal Cognitive Assessment (MOCA)
  • Cognitive performance [ Time Frame: 3-months ]
    Neurobehavioural Cognitive State Examination (NCSE)
  • Cognitive performance [ Time Frame: 3-months ]
    Rivermead Behavioural Memory Test (RBMT)
Change History Complete list of historical versions of study NCT03791996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Motor assessment [ Time Frame: 3-months ]
    Medical Research Council limb power
  • Modified Functional Ambulation Category (MFAC) [ Time Frame: 3-months ]
    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).
  • Quality of life assessment [ Time Frame: 3-months ]
    Short Form-36 (SF-36)
  • Psychological assessment [ Time Frame: 3-months ]
    Beck depression inventory (BDI)
  • Caregiver assessment [ Time Frame: 3-months ]
    Caregiver Strain Index
  • Caregiver [ Time Frame: 3-months ]
    Caregiver self-assessment questionnaire
  • MRI cerebral perfusion assessment [ Time Frame: 3-months ]
    Cerebral blood flow
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2018)
  • Motor assessment [ Time Frame: 3-months ]
    Medical Research Council limb power
  • Motor assessment [ Time Frame: 3-months ]
    Modified Functional Ambulation Category (MFAC)
  • Quality of life assessment [ Time Frame: 3-months ]
    Short Form-36 (SF-36)
  • Psychological assessment [ Time Frame: 3-months ]
    Beck depression inventory (BDI)
  • Caregiver assessment [ Time Frame: 3-months ]
    Caregiver Strain Index
  • Caregiver [ Time Frame: 3-months ]
    Caregiver self-assessment questionnaire
  • MRI cerebral perfusion assessment [ Time Frame: 3-months ]
    Cerebral blood flow
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranioplasty Cognitive Outcome Study
Official Title  ICMJE Impact of Cranioplasty on Cognitive Outcome: A Multi-Center Prospective Randomized Study
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.

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description:
1:1 block central randomisation with assignments written on a card sealed in an opaque envelop.
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Impairment
  • Brain Herniation
Intervention  ICMJE Procedure: "Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.
Study Arms  ICMJE
  • No Intervention: "Late" cranioplasty
    Subjects undergoing cranioplasty within 3 months after craniectomy.
  • Experimental: "Early" cranioplasty
    Subjects undergoing cranioplasty beyond 3 months after craniectomy.
    Intervention: Procedure: "Early" cranioplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age older than 80 years-old,
  2. Patients cannot communicate by obeying simple command,
  3. Patients who are unfit for cranioplasty as decided by the treating neurosurgeon
  4. Posterior fossa craniectomy
  5. Craniectomy performed before 1st March 2019
  6. Craniectomy performed at an institution outside the Hospital Authority
  7. Any pre-existing illness that renders the patient moderately or severely disabled before the brain insult.
  8. Patients that need an additional procedure e.g. cerebrospinal fluid shunting with cranioplasty in the same setting.
  9. History of central nervous system infection
  10. Craniectomy-related complications such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect patient's long-term cognitive outcome
  11. Claustrophobia or any other medical condition that prohibits the patient from undergo MRI scanning
  12. Patients who cannot understand spoken English or Chinese
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Calvin Mak, MBBS FRCS 35066026 mhk349@ha.org.hk
Contact: Marina Lee 35066026 leeymm@ha.org.hk
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03791996
Other Study ID Numbers  ICMJE CCO-RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter Woo Yat Ming, Kwong Wah Hospital
Study Sponsor  ICMJE Kwong Wah Hospital
Collaborators  ICMJE
  • Queen Elizabeth Hospital
  • Queen Mary Hospital, Hong Kong
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Princess Margaret Hospital, Canada
  • Tuen Mun Hospital
  • Pamela Youde Nethersole Eastern Hospital
Investigators  ICMJE
Principal Investigator: Calvin Mak, MBBS FRCS Neurosurgery, Queen Elizabeth Hospital
PRS Account Kwong Wah Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP