Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized...

Area of Science:

• Neurology
• Immunology
• Clinical Trials

Background:

• Stroke survivors often face long-term neurological impairments with limited treatment options.
• Etanercept, a TNF inhibitor, has shown promise in observational studies for improving post-stroke deficits.
• Perispinal injection may facilitate etanercept crossing the blood-brain barrier.

Purpose of the Study:

• To investigate the efficacy and safety of perispinal etanercept in improving quality of life for chronic stroke survivors.
• To provide level 1 evidence for this novel stroke treatment approach.

Main Methods:

• A multicenter, international, randomized placebo-controlled trial (PESTO).
• Adult participants with stroke history (1-15 years) and modified Rankin Scale 2-5 randomized 1:1 to etanercept or placebo.
• Primary outcome: quality of life (Short Form 36) at 28 days post-injection.

Main Results:

• The study is designed to detect a significant improvement in SF-36 scores in the etanercept group compared to placebo.
• Safety outcomes, including serious adverse events, will be monitored.

Conclusions:

• PESTO aims to establish the safety and efficacy of perispinal etanercept for long-term stroke disability.
• Results will inform potential new therapeutic strategies for stroke recovery.