Can neurofeedback recover hand movement after stroke?

Can Restorative Brain-Computer interfaces Improve Hand Motor Functions after a Stroke?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000779875

Enrollment

Registered

2021-06-22

Start date

2020-11-11

Completion date

2021-09-15

Last updated

2021-06-28

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

Conditions

None listed

Brief summary

Stroke survivors suffer from impaired movements that affect their activities of daily living. Conventional physio and occupational therapies are provided to regain some of these lost motor abilities. However, even with intensive conventional therapy, a large portion of patients do not receive sufficient recovery to function independently. This deficit leads to significant social and economic burdens. Therefore, there is a clear need for the development of novel and effective intervention strategies. To address the gap, alternative therapies, including brain-computer interfaces, have been proposed to recover impaired hand functions following stroke. A brain-computer interface (BCI) can translate the imagination of hand movement to the movement of an object on a screen or even the actual hand movement provided by a robotic hand. In a BCI system, a specific cap records the electrical activity of the brain on the surface of the scalp during the imagination of the hand movement. A machine learning algorithm processes the recorded brain signals and determines if the imagination of movement has been performed. When the algorithm detects the movement imagination, it sends commands to the outside world and provides feedback to the user. A specific type of feedback may be supplied via a robotic hand to move a paralysed hand passively, during the imagination of the hand movement. There is a growing body of research, demonstrating the promising primary results of the application of BCIs for movement recovery after stroke. However, to supply BCI as standard therapy in clinics, its consistency and efficacy need to be improved. One of our prior studies suggests the outperformance of proprioceptive feedback over traditional visual feedback in the provision of a better substrate for the occurrence of operant learning. Further, we have demonstrated that provision of the correct delay between the brain activation and the passive hand movement is critical and must be customised according to individual’s attributes. Putting together the findings of the two prior studies, we improved the hand movement of a stroke patient, who had had a stroke 3.5 years before the study, by 36% after ten sessions of therapy. Observing the promising results of the aforementioned studies, we are investigating how our novel BCI therapy recovers the hand movement for a group of stroke survivors.

Interventions

Can neurofeedback recover hand movement after stroke? The rationale for Clinical Investigation: Finding novel and efficacious methods for motor recovery after stroke is a prominent unmet need. RehabSwift’s single-case study provided promising and clinically significant outcomes. Therefore, running a study involving up to 15 chronic stroke patients will determine whether and to what extent the observed results from the single case study can be generalized to the larger patient populations Investigational Device: The investigational device includes: o an Electroencephalogram (EEG) cap and amplifier; o a machine learning algorithm residing in a PC; and o a bionic hand that provides haptic feedback. o Electromyogram (EMG) electrodes attached to finger flexor/ extensor muscles. The sponsor will provide the devices to the investigation site for the duration of the trial. Study Procedures Participants first attend a screening session during which they are screened for compatibility with the inclusion criteria. This includes monitoring patients vs the eligibility criteria elborated in step 5. Participants will also perform a brief run of motor imagery whilst their EEG signals are recorded. The overall screening session is expected to take up to two hours. Those who pass the inclusion criteria, attend 18 neurofeedback training sessions over six consecutive weeks (three days per week). During training sessions, the performance of motor imagery of finger extension/flexion will be rewarded by the actual finger extension/flexion using bionic hands involved with participants’ affected hands. Every neurofeedback training session starts with the preparation of the patient to wear an EEG cap and also attachment of up to four EMG electrodes to their arm muscles. Next, a measurement of the reaction time of the patient will be implemented. Reaction time measurement will occur by involving the participant's hands in the bionic hands and having them following through with an extension or flexion movement of their fingers as fast as possible in response to a timed extension/flexion movement from the bionic hands. The response between the bionic hand movement and participant muscular activity will be monitored. Then eight runs of neurofeedback training will be implemented, where each run includes conducting 20 motor imagery and relaxation trials in a randomised order. The motor imagery trials consist of asking the participants to imagine extend/flex their fingers. Relaxation trials will involve asking participants to remain still and do nothing such as concentrating on a blank wall. There will be 2-minute breaks between consecutive runs and collectively each neurofeedback training session is expected to take approximately one hour. Participants' attendance will be recorded as well as lab notes corresponding to each session. Neurofeedback training sessions will be provided by an experienced and well-trained experimenter with a background in neuroscience and/or psychology. The intervention will be provided face to face and individually. The intervention would take place at the University of Adelaide where all the necessary machinery will be provided by the sponsor for the duration of the trial.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

The prospective participants have to fulfill the following inclusion criteria: 1- being at least six months post-stroke and in a stable condition; 2- having impaired motor capabilities in their affected arm determined by an ARAT score less than 45 out of 57; 3- having intact cognitive functions determined by the mini-mental state examination (MMSE) score to be more than 26 out of 30; 4- being independently mobile—with or without a walking aid; 5- not having excessive tone in their arm and hand muscles determined by the modified Ashworth test score to be less than 3 out of 4; 6- having the ability to perform vivid MI—by screening their ability in generating discriminable MI vs relaxation EEG signals; 7- having an (almost) intact sense of proprioception—by screening their blind judgment of comparing the size of seven polystyrene balls with more than 50% accuracy; 8- the ability to fully understand and comprehend auditory instructions presented in English to perform motor imagery.

Exclusion criteria

1- individuals with comorbidities such as arthritis in the hands/fingers of their affected side will be excluded. 2- individuals who do not think they can fulfil the visit attendance requirements will be excluded. 3- Visual or hearing impairment.

Outcome results