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Challenges and Opportunities in Stroke Recovery and Rehabilitation Trials

The Recovery & Rehabilitation Group led by Dr. Steven C. Cramer discussed key considerations in stroke recovery trials during the NIH StrokeNet Network Meeting. They highlighted challenges such as the young field of investigation, defining biomarkers, and the need for multidisciplinary teams. They also emphasized the value of understanding patient priorities, exploring unfamiliar therapeutic interventions, and using detailed endpoints. Despite resource-intensive aspects, there are opportunities for integrating recovery trials into acute and prevention studies within the StrokeNet network.

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Challenges and Opportunities in Stroke Recovery and Rehabilitation Trials

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  1. NIH StrokeNet Network Meeting October, 2023 DOMAIN SPECIFIC CONSIDERATIONS Recovery& Rehabilitation Group Steven C. Cramer, MD

  2. 101 responses 65 PI 36 Coordinator

  3. 10 Understanding priorities of patients with stroke 9 Drug trials 9 Collaboration with engineers 9 Caregivers of patients with stroke 9 Perceived value that stroke rehab/recovery trials have 9 Cost of a new rehab/recovery therapy 9 Recruitment/training of next generation of trialists in stroke rehab/recovery

  4. 10 Understanding priorities of patients with stroke 9 Drug trials 9 Collaboration with engineers 9 Caregivers of patients with stroke 9 Perceived value that stroke rehab/recovery trials have 9 Cost of a new rehab/recovery therapy 9 Recruitment/training of next generation of trialists in stroke rehab/recovery

  5. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation

  6. PubMed search “stroke recovery”

  7. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined

  8. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar

  9. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar •Often need many treatment sessions

  10. “After extensive lesions, the amount of training necessary to reestablish the habits is much increased.” Lashley, KS. J Nervous Mental Disease. 1938; 88: 733-755.

  11. 20 treatment sessions

  12. 20 treatment sessions 36 treatment sessions Cramer et al. JAMA Neurology. 2019; 76:1079-1087

  13. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar •Often need many treatment sessions •Often patients change treatment setting during the trial

  14. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar •Often need many treatment sessions •Often patients change treatment setting during the trial •Often require multidisciplinary teams

  15. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar •Often need many treatment sessions •Often patients change treatment setting during the trial •Often require multidisciplinary teams •Can study unfamiliar forms of therapeutic intervention

  16. Unique challenges to stroke recovery/rehabilitation trials •Young field of investigation •Biomarkers still being defined •Biomarkers are sometimes unfamiliar •Often need many treatment sessions •Often patients change treatment setting during the trial •Often require multidisciplinary teams •Can study unfamiliar forms of therapeutic intervention •Often use detailed endpoints; some require special expertise

  17. Stroke 2021; 52:1154-1161

  18. Stroke 2021; 52:1154-1161

  19. Stroke 2021; 52:1154-1161 WHY? Increased resolution Better insight into recovery Individual brain systems

  20. Examined different behaviors in relation to mRS score Erler et al. Neurology. 2022; 98:e1877-e1885

  21. Examined different behaviors in relation to mRS score • Specific behaviors show a wide range at any given mRS score Erler et al. Neurology. 2022; 98:e1877-e1885

  22. Examined different behaviors in relation to mRS score • Specific behaviors show a wide range at any given mRS score • Values overlap substantially with neighboring mRS scores Erler et al. Neurology. 2022; 98:e1877-e1885

  23. Stroke 2021; 52:1154-1161 WHY? Increased resolution Better insight into recovery Individual brain systems BUT Can be resource intensive Less familiar May require special hardware

  24. Opportunities in StrokeNet

  25. Opportunities in StrokeNet • Common endpoints across all StrokeNet trials; big data • Can integrate recovery trials into acute and prevention studies • Potential to join forces for patient recruitment

  26. NIH StrokeNet Network Meeting October, 2023 DOMAIN SPECIFIC CONSIDERATIONS Recovery& Rehabilitation Group Steven C. Cramer, MD

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