Cranioplasty Cognitive Outcome Study

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791996
• Other study ID #: CCO-RCT
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: October 2019
• Source: Kwong Wah Hospital
• Contact: Calvin Mak, MBBS FRCS
• Phone: 35066026
• Email: mhk349[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Herniation
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Procedure:
• "Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.

Locations

Country	Name	City	State
China	Kwong Wah Hospital	Hong Kong	Hong Kong

Sponsors (7)

Lead Sponsor	Collaborator
Kwong Wah Hospital	Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Princess Margaret Hospital, Canada, Queen Elizabeth Hospital, Queen Mary Hospital, Hong Kong, Tuen Mun Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View Citation

Bender A, Heulin S, Röhrer 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 — View Citation

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. Review. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment (MOCA)	Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.	3-months
Primary	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
Primary	Rivermead Behavioural Memory Test (RBMT)		3-months
Secondary	Motor assessment	Medical Research Council limb power	3-months
Secondary	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).	3-months
Secondary	Quality of life assessment	Short Form-36 (SF-36)	3-months
Secondary	Psychological assessment	Beck depression inventory (BDI)	3-months
Secondary	Caregiver assessment	Caregiver Strain Index	3-months
Secondary	Caregiver	Caregiver self-assessment questionnaire	3-months
Secondary	MRI cerebral perfusion assessment	Cerebral blood flow	3-months