Trial results for a study investigating stroke rehabilitation using Brain-Computer Interface (BCI) technology were posted on ClinicalTrials.gov on 2025-11-04, with 84 participants enrolled.
Background
Stroke is a leading cause of long-term disability, often resulting in upper-limb hemiparesis. Current rehabilitation strategies aim to restore motor function and improve quality of life. This study explored the potential of functional muscle stimulation, directed by electroencephalogram (EEG) output, to enhance stroke recovery. The research aimed to determine if this technology could increase the extent of recovery on behavioral measures and induce brain plasticity, as measured by functional magnetic resonance imaging (fMRI).
Trial design
This completed study, designated as Phase NA, enrolled 84 participants with Stroke, specifically those experiencing upper-limb hemiparesis. The trial investigated functional muscle stimulation, directed by electroencephalogram (EEG) output. Participants were on study for approximately 4 months. The study compared outcomes between a Passive FES group and an Active FES group.
Key results
The trial reported several key measurements related to upper-limb function and stroke impact:
- Action Research Arm Test Scores (score on a scale):
- For the Passive FES group, mean scores were 28.10 (Standard Deviation 17.84), 29.95 (Standard Deviation 17.30), 32.53 (Standard Deviation 16.97), and 31.78 (Standard Deviation 16.85).
- For the Active FES group, mean scores were 27.76 (Standard Deviation 18.38), 30.18 (Standard Deviation 18.30), 32.83 (Standard Deviation 18.60), and 34.10 (Standard Deviation 18.57).
- Stroke Impact Scale (score on a scale):
- For the Passive FES group, mean scores were 61.90 (Standard Deviation 24.68) and 70.29 (Standard Deviation 19.81).
- For the Active FES group, mean scores were 66.07 (Standard Deviation 23.32) and 68.22 (Standard Deviation 22.00).
What this means
The posted results provide specific mean scores and standard deviations for functional recovery and stroke impact in patients undergoing rehabilitation with Brain-Computer Interface technology. The data includes measurements from both passive and active functional electrical stimulation (FES) groups on the Action Research Arm Test and the Stroke Impact Scale. While these measurements offer insights into the observed outcomes, no comparative analyses or statistical significance values were reported to indicate differences between the groups or overall efficacy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04141774, titled "Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology", were posted on 2025-11-04 on clinicaltrials.gov.