None listed
Conditions
Brief summary
The primary aim of the study is to determine the safety and tolerability of perispinal injection of Etanercept in subjects who have had a stroke and have stable and persistent chronic neurological dysfunction, cognitive impairment, and chronic and intractable pain due to stroke. The effects of the perispinal Etanercept treatment on neurological dysfunction, cognitive impairment, and chronic post-stroke pain will be examined as secondary aims by neurological examination as well as by the use of standarized measures.
Interventions
Enbrel (Etanercept, 25 mg mixed with 1.8 ml of non-bacteriostatic sterile water.
) delivered by perispinal injection using a short (27g x 0.5 inch) needle twice over a space of 2 weeks administered by clinical investigators including an anaesthetist, neurologist and a general practitioner. Monitoring of adherence by log of dose timings. Change made prior to any patient enrolment.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic neurological impairment, including hemiparesis, following stroke that occurred at least 6 months and not more than 10 years prior to screening for this study. 2. A previous ischemic or hemorragic stroke in 1). the territory of the right or left middle cerebral artery (MCA); or 2). subarachnoid hemorrhage. 3. Age between 30-80. Age at 80 maximum to avoid possible morbidity on trial. 4. Stroke-induced cognitive impairment by history (difficulty with memory or cognition). The chronic stroke is associated with severe cognitive impairment and assessment of cognitive function by MMSE score is 16-25, or Montreal Cognitive Assessment (MOCA) score is measured in the range of 12-24, inclusive performed upon assessment during enrolment. 5. Individual has walking impairment but is ambulatory (with or without a quad cane or single point cane or walker) without assistance from another individual. 6. Chronic and intractable neuropathic pain due to stroke with pain score between 4 to 8 inclusive on the vertical assessment score.
Exclusion criteria
1. Dementia or cognitive impairment prior to date of stroke 2. Brain stem stroke 3. More than one stroke in the past 3 years 4. Pain score of less than 4 or above 8 out of 10 on the vertical assessment scale (VAS) 5. Parkinson’s Disease or Parkinsonian symptoms 6. Dementia with Lewy bodies 7. Multiple sclerosis 8. Demyelinating disease 9. History of tuberculosis 10. Positive PPD 11. HIV infection 12. History of hepatitis 13. History of deep fungal infection (coccidiodomycosis, histoplasmosis, blastomycosis) 14. Active infection 15. Indwelling urinary catheter 16. Lymphoma, active or in the past 17. Cancer 18. Uncontrolled diabetes mellitus 19. Patients using any other immunosuppressive medication, including Kineret (Anakinra) or Abatacept, or glucocorticoids. 20. Use of a TNF inhibitor (etanercept, infliximab, etc.) in the past 21. Congestive Heart Failure 22. Non-ambulatory 23. Less than two months since hospitalization for any cause 24. Pregnancy 25. Psychosis or use of anti-psychotic medication (e.g. olanzapine, quetiapine, clozapine, aripiprazole, haloperidol, flupenazine, risperidone, ziprasidone) 26. History of Alcohol abuse 27. Autoimmune disorder 28. Previous neck surgery (such as cervical fusion) 29. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder), which, in the opinion of the investigator, would affect the assessment of the safety and tolerability of perispinal Etanercept. 30. Not taking an anticoagulant or an anti-platelet drug 31. No severe aphasia, as investigators need to be able to converse with the patients from the outset to reasonably assess their medical condition.
Outcome results
None listed