Skip to content

The optimal delivery of a Brain Computer Interface intervention for people with stroke.

An investigation of the optimal method for delivering a Brain Computer Interface intervention to improve the brain-muscle connection following stroke.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001313123
Enrollment
25
Registered
2019-09-26
Start date
2019-12-02
Completion date
2020-06-01
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the optimal method for delivering a Brain Computer Interface intervention to improve brain activity and the ability to move the affected leg, in people with chronic stroke (>6 months). The aim of this research is to investigate the immediate effects of three different interventions: 1) Brain Computer Interface Intervention using the persons brain activity to time the intervention, 2) Brain Computer Interface Intervention using a visual cue to time the intervention, and 3) Control intervention. The study will use a repeated measures cross-over design, where each participant will receive each of the three interventions on three different days, 7 days apart, in a randomised order. Participants will undergo a number of tests before and after each intervention, to determine the effects of each intervention on brain and muscle activity.

Interventions

Each participant will receive three different conditions, two interventions, and one control, on three different days, 7 days apart (in a randomised order). Participants will be blinded to this order. At the start of each session, electroencephalography (EEG) will be recorded using an EEG cap, while participants perform 50 repetitions of active ankle dorsiflexion of their affected leg, in time with a visual cue. The visual cue is a moving cursor on a computer screen which prompts the participan

Each participant will receive three different conditions, two interventions, and one control, on three different days, 7 days apart (in a randomised order). Participants will be blinded to this order. At the start of each session, electroencephalography (EEG) will be recorded using an EEG cap, while participants perform 50 repetitions of active ankle dorsiflexion of their affected leg, in time with a visual cue. The visual cue is a moving cursor on a computer screen which prompts the participant to prepare and then move their ankle. The EEG is then analysed and the peak negativity of the movement related cortical potential (MRCP) is determined. This timing is then used to inform the timing of one of the interventions. For the two interventions, the participant will complete 50 repetitions of cued active ankle dorsiflexion of the affected leg. During each repetition of ankle dorsiflexion, a single pulse of electrical stimulation (pulse width 1ms) will be delivered to the deep branch of the common peroneal nerve (via two surface electrodes placed approximately 2-5cm anterior and inferior to the head of the fibula). The intensity of the electrical stimulation will be set to the level required to produce a palpable twitch in the tibialis anterior tendon (device intensity range 0-100mA). For the first intervention, each pulse of electrical stimulation will be timed to arrive in the motor cortex at the point of peak negativity of the MRCP. This timing is set from the pre-recorded MRCP, and therefore is an 'off-line' version of a Brain Computer Interface (comprised of an EEG recording, a computer analysing the EEG and triggering the stimulator, and an electrical stimulation unit). For the second intervention, each pulse of electrical stimulation will be timed to arrive in the motor cortex at the time the visual cue is given (to move the affected leg). The intervention takes approximately 15 minutes, with additional time required for setting up the electrical stimulation. Sessions will be delivered by a trained research assistant. The parameters of intervention delivery and any clinical observations concerning the participants engagement and adherence to the intervention will be recorded on data collections sheets.

Sponsors

Auckland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Single stroke causing hemiparesis and neuromuscular weakness of the ankle dorsiflexor muscles. - More than 6 months post stroke.

Exclusion criteria

- Complete paralysis of the ankle - Being unable to engage in the testing due to significant cognitive, perceptual or communication deficits - Cerebellar stroke - Another medical condition that may impact safety of the testing or the reliability of the results.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026