Adults 18 to 80, any sex, with Ischemic Stroke or Hemorrhagic Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Gait VelocityPrimary· Baseline to End of Therapy (4 weeks after initiation of therapy)
Gait velocity will be assessed by measuring the time to traverse the middle 6 m of a 10-m walkway (5 repetitions/assessment). Scores are reported in meters/second with higher scores indicating better function.
Baseline
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
0.38
± 0.21
Dose-and Intensity-matched Physiotherapy
0.38
± 0.26
End of Therapy
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
0.46
± 0.23
Dose-and Intensity-matched Physiotherapy
0.45
± 0.34
Dorsiflexion Range of MotionSecondary· Baseline and end of therapy (4 weeks after initiation of therapy)
The paretic foot will be placed in a dangling, subtalar neutral position idling, while the tibia is perpendicular to the ground and the femur horizontal to the ground. A goniometer will be used to measure the maximum dorsiflexion angle, in degrees. 0 degrees indicates a neutral ankle position (foot horizontal to the ground, while tibia is perpendicular to the ground). Positive degrees indicate a maximum dorsiflexion angle above the neutral position, while negative degrees indicates a maximum angle below the neutral position (a larger, more positive measure indicates higher function).
Baseline
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
-12.54
± 13.78
Dose-and Intensity-matched Physiotherapy
-16.67
± 15.78
End of Therapy
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
-10.05
± 13.07
Dose-and Intensity-matched Physiotherapy
-13.94
± 15.74
Gait Endurance (Six Minute Walk Test: 6MWT)Secondary· Baseline to End of Therapy (4 weeks after initiation of therapy)
The distance walked over 6 minutes. Score is reported in meters and higher score indicates better function.
Baseline
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
101.08
± 57.16
Dose-and Intensity-matched Physiotherapy
105.74
± 75.60
End of Therapy
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
118.19
± 60.91
Dose-and Intensity-matched Physiotherapy
118.83
± 85.38
Fall FrequencySecondary· Baseline to End of Therapy (4 weeks after initiation of therapy)
Rate of falls experienced by subjects
Baseline
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
0.11
± 0.32
Dose-and Intensity-matched Physiotherapy
0.08
± 0.27
End of Therapy
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
0
± 0
Dose-and Intensity-matched Physiotherapy
0
± 0
EEG Map (Electroencephalogram)Secondary· Baseline to End of Therapy (4 weeks after initiation of therapy)
Subjects will undergo 64-channel EEG recording as they engage in 100 alternating 10-s long epochs of idling and attempted dorsiflexion. The EEG modulation, defined as the change in alpha (8-12 Hz) and beta (13-30 Hz) band power during attempted dorsiflexion (compared to idling) will be calculated and averaged over all epochs and across all channels. Change in EEG alpha and beta band power will be express as percentage with respect to the idle state. Specifically, the change in the Channel Cz will be reported given its primary salience to attempted dorsiflexion.
Baseline
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
-31.73
± 18.55
Dose-and Intensity-matched Physiotherapy
-39.48
± 18.84
End of Therapy
Group
Value
95% CI
BCI-FES Dorsiflexion Therapy With Physiotherapy
-38.74
± 25.10
Dose-and Intensity-matched Physiotherapy
-36.33
± 22.10
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to End of 3-month post intervention follow up.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BCI-FES Dorsiflexion Therapy With Physiotherapy
Serious: 7/32 (22%)
Deaths: 0/32
Dose-and Intensity-matched Physiotherapy
Serious: 3/30 (10%)
Deaths: 0/30
Serious adverse events (4 terms)
Reaction
System
BCI-FES Dorsiflexion Thera…
Dose-and Intensity-matched…
Cardiac events
Cardiac disorders
—
—
Severe adverse events (unrelated to study procedures)
There are over 7 million stroke survivors in the US alone, with approximately 795,000 new cases annually. Despite the best available physiotherapy, 30-60% of stroke survivors remain affected by difficulty walking, with foot weakness often being the main cause. Given that post-stroke gait impairments remain poorly addressed, new methods that can provide lasting improvements are necessary. Brain-computer interface (BCI) technology may be one such novel approach. BCI technology enables "direct brain control" of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. BCI-FES systems are hypothesized to stimulate recovery after stroke beyond that of conventional physical therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Irvine
Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04279067.