Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Clinical Trials

Background:

• Brain stimulation, including transcranial direct current stimulation (tDCS), is an emerging adjuvant therapy for post-stroke rehabilitation.
• Evaluating enrollment criteria in clinical trials is crucial for understanding treatment accessibility and effectiveness.

Purpose of the Study:

• To assess the impact of inclusion and exclusion criteria on patient enrollment in a tDCS trial.
• To investigate enrollment barriers within a racially and ethnically diverse acute stroke patient population.

Main Methods:

• Screened 3124 diverse acute stroke patients at University of Texas Southwestern (UTSW).
• Collected prospective data on demographics, stroke characteristics, and reasons for exclusion.
• Analyzed eligibility and enrollment rates based on specific criteria.

Main Results:

• Only 44 (1.9%) of 2327 verified stroke patients were eligible for the trial.
• Key exclusion factors included upper extremity motor impairment, prior strokes, and hemorrhagic stroke.
• While most patients could be safely stimulated, enrollment diversity was limited, with specific exclusions disproportionately affecting African American patients.

Conclusions:

• Upper extremity motor impairment and stroke characteristics are primary barriers to trial inclusion.
• Transcranial direct current stimulation (tDCS) is generally safe for most stroke patients.
• Refining inclusion criteria can significantly improve diversity in brain stimulation trials for stroke recovery.