An interventional study of "Early" cranioplasty in Cognitive Impairment and Brain Herniation, sponsored by Kwong Wah Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by Kwong Wah Hospital · Not applicable, Interventional, and Treatment
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.
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)
3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Kwong Wah Hospital is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects undergoing cranioplasty within 3 months after craniectomy.
Subjects undergoing cranioplasty beyond 3 months after craniectomy.
Procedure: "Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.
Montreal Cognitive Assessment (MOCA)
Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.
Time frame: 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.
Time frame: 3-months
Rivermead Behavioural Memory Test (RBMT)
Time frame: 3-months
Motor assessment
Medical Research Council limb power
Time frame: 3-months
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).
Time frame: 3-months
Quality of life assessment
Short Form-36 (SF-36)
Time frame: 3-months
Psychological assessment
Beck depression inventory (BDI)
Time frame: 3-months
Caregiver assessment
Caregiver Strain Index
Time frame: 3-months
Caregiver
Caregiver self-assessment questionnaire
Time frame: 3-months
MRI cerebral perfusion assessment
Cerebral blood flow
Time frame: 3-months
Plan to share: No
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Kwong Wah Hospital