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Cranioplasty Cognitive Outcome Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03791996
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : October 17, 2019
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

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Brain Herniation Procedure: "Early" cranioplasty Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Impact of Cranioplasty on Cognitive Outcome: A Multi-Center Prospective Randomized Study
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
No Intervention: "Late" cranioplasty
Subjects undergoing cranioplasty within 3 months after craniectomy.
Experimental: "Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.
Procedure: "Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MOCA) [ Time Frame: 3-months ]
    Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.

  2. 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.

  3. Rivermead Behavioural Memory Test (RBMT) [ Time Frame: 3-months ]

Secondary Outcome Measures :
  1. Motor assessment [ Time Frame: 3-months ]
    Medical Research Council limb power

  2. 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).

  3. Quality of life assessment [ Time Frame: 3-months ]
    Short Form-36 (SF-36)

  4. Psychological assessment [ Time Frame: 3-months ]
    Beck depression inventory (BDI)

  5. Caregiver assessment [ Time Frame: 3-months ]
    Caregiver Strain Index

  6. Caregiver [ Time Frame: 3-months ]
    Caregiver self-assessment questionnaire

  7. MRI cerebral perfusion assessment [ Time Frame: 3-months ]
    Cerebral blood flow

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03791996

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Contact: Calvin Mak, MBBS FRCS 35066026
Contact: Marina Lee 35066026

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China, Hong Kong
Kwong Wah Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Peter YM Woo, FRCS (SN)    852+ 3517 2275 ext 2275   
Principal Investigator: Peter YM Woo, FRCS (SN)         
Sponsors and Collaborators
Kwong Wah Hospital
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
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Principal Investigator: Calvin Mak, MBBS FRCS Neurosurgery, Queen Elizabeth Hospital

Publications of Results:
Other Publications:
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Responsible Party: Peter Woo Yat Ming, Principal Investigator, Kwong Wah Hospital Identifier: NCT03791996     History of Changes
Other Study ID Numbers: CCO-RCT
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Woo Yat Ming, Kwong Wah Hospital:
Cognitive impairment
Syndrome of the trephined
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders