Trial results for a study investigating Transcranial Direct Current Stimulation (tDCS) for post-stroke gait rehabilitation were posted on ClinicalTrials.gov on 2025-06-10. The completed trial enrolled 44 participants with stroke and gait impairment.
Background
Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Current gait rehabilitation treatments are limited, and many stroke survivors do not achieve full recovery, highlighting the need for new approaches to enhance rehabilitation methods.
Trial design
This completed trial, designated as Phase NA, enrolled 44 participants with conditions including Stroke and Gait Impairment. The study compared an Active tDCS intervention group against a Sham tDCS control group, evaluating their effects on post-stroke gait rehabilitation.
Key results
The trial reported several key measurements comparing Active tDCS to Sham tDCS:
- Change in Gait Speed From Baseline (Meters/Second):
- Active tDCS: mean 0.16 meters/second (Standard Deviation 0.183)
- Sham tDCS: mean 0.12 meters/second (Standard Deviation 0.141)
- Change From Baseline to Post Treatment on Timed up and go (Seconds):
- Active tDCS: mean -6.93 seconds (Standard Deviation 16.957)
- Sham tDCS: mean -5.7 seconds (Standard Deviation 8.314)
- Change From Baseline to Post Treatment in Functional Gait Assessment (Points):
- Active tDCS: mean 2.79 points (Standard Deviation 3.047)
- Sham tDCS: mean 2.38 points (Standard Deviation 1.717)
- Change From Baseline to Post Treatment on Fugl Meyer Lower Limb:
- Active tDCS: mean 2.26 points (Standard Deviation 1.996)
- Sham tDCS: mean 2.62 points (Standard Deviation 2.334)
- Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool:
- Active tDCS: mean -2.42 points (Standard Deviation 2.219)
- Sham tDCS: mean -2.86 points (Standard Deviation 2.78)
- Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline:
- Active tDCS: 9 Participants
- Sham tDCS: 8 Participants
What this means
The results indicate that both active and sham transcranial direct current stimulation were associated with improvements in several gait and functional measures for stroke survivors. Specifically, the active tDCS group showed a slightly larger mean increase in gait speed (0.16 m/s vs 0.12 m/s for sham) and functional gait assessment scores (2.79 points vs 2.38 points for sham). Conversely, the sham tDCS group showed a slightly larger mean improvement in Fugl Meyer Lower Limb scores (2.62 points vs 2.26 points for active) and Gait Assessment and Intervention Tool scores (-2.86 points vs -2.42 points for active). While these changes suggest potential benefits, the absence of statistical analyses prevents conclusions about the comparative efficacy or significance of active tDCS over sham tDCS based solely on these mean values.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03666533, titled "Transcranial Direct Current Stimulation for Post-stroke Gait Rehab", were posted on 2025-06-10 on clinicaltrials.gov.