Trial results for a study investigating synchronized brain and hand stimulation after stroke were posted on ClinicalTrials.gov on 2025-07-15, showing a 20% mean improvement in the Box and Block Test for motor function.
Background
Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently, there is a dearth of understanding of the mechanisms of motor recovery after stroke. Understanding these mechanisms can potentially lead to the development of interventions to improve motor performance after stroke. This study aimed to examine how synchronously pairing brain and hand stimulation repeatedly affects brain plasticity and motor performance.
Trial design
This completed study, designated as Phase NA, enrolled 10 participants to investigate conditions including Stroke and Upper Extremity Paresis. The trial examined the effects of combined non-invasive brain and functional electrical stimulation. The study design utilized a paired t-test for analysis, suggesting a within-subject comparison to evaluate the intervention's impact.
Key results
The trial reported several key measurements and their analyses for the combined non-invasive brain and functional electrical stimulation group:
- Percent Change in Box and Block Test: Participants showed a mean change of 20 percent (Standard Deviation 5 percent change of number of blocks). A paired t-test indicated statistical significance with a p-value of 0.04.
- Percent Change in Motor Evoked Potential: A mean change of 40 percent (Standard Deviation 7 percent change of motor evoked potential) was observed. A paired t-test indicated statistical significance with a p-value of 0.02.
- Average Percent Change in Hand Force: Participants demonstrated a mean change of 10 percent (Standard Deviation 2 percent change of force). A paired t-test indicated statistical significance with a p-value of 0.04.
What this means
The results suggest that synchronized brain and hand stimulation may offer a promising approach for improving motor function, brain plasticity, and hand force in individuals experiencing upper extremity paresis after stroke. The statistically significant improvements observed across multiple outcome measures, despite the small sample size, warrant further investigation into this intervention. These findings contribute to the understanding of potential mechanisms for motor recovery and could inform the development of new therapeutic strategies for stroke rehabilitation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04502290, titled "Synchronized Brain and Hand Stimulation After Stroke", were posted on 2025-07-15 on clinicaltrials.gov.