Motor conditioning to enhance the effect of physical therapy
Research type
Research Study
Full title
Exploring brain computer interface controlled functional electrical stimulation as a motor conditioning strategy prior to physical theraphy of the upper limb in people with subacute spinal cord injury
IRAS ID
268302
Contact name
Aleksandra Vuckovic
Contact email
Sponsor organisation
NHS for Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 28 days
Research summary
Research Summary
Spinal Cord Injury (SCI) affects person’s ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study we would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this we will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to patients hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment.
We will have a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on patients who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. We will compare the outcomes between the treatment and the control group and between the dominant and the non-dominant hand of each participant.Summary of Results
Objective: This study is looking into increasing the effect of physical rehabilitation of hands in patients with recent spinal injuries, by using technology based on Brain Computer Interface and Functional Electrical Stimulation (FES).
Brain-Computer Interface (BCI) consists of a device for recording brain activity and a computer, and brain activity is analysed while being recorded. This activity is then made visible on a computer screen in the form of a scale, which moves proportional to the brain activity while the patient with an injured spinal cord attempts to use their hands to the best of their abilities. When BCI detects that the person is trying to use their hands, it activates an FES device. The FES device has a pair of electrodes attached to the patient’s forearm, which stimulates the muscles so that the patient can move the hand.Due to Covid 19 we had to finish the study early, so we recruited only 10 out of the planned 26 patients. In the study, we compared two groups of patients. One group ( 5 patients) had 20 sessions that consisted of 15 min BCI-FES practice followed by 30 min hand therapy, while the other group (5 patients) had 40 min of hand therapy only.
We measured improvement in hand functions (grip strength, range of movement), dropout, mental difficulty of using BCI and changes in brain activity (using a device called electroencephalograph EEG) before and after 20 sessions in each group.
There was no difference in improvement in hand function between groups but there were significant pre/post-therapy changes in brain activity only in the group who received BCI-FES, and these changes are indicative of recovery.
Conclusion: The number of participants was too small for definitive conclusions, but in the future BCI-FES should last longer than 15 min to see a greater effect on recovery. Changes in brain activity in groups using BCI-FES indicate that this technology might be beneficial if it is used for a longer time.REC name
West of Scotland REC 3
REC reference
20/WS/0010
Date of REC Opinion
10 Mar 2020
REC opinion
Further Information Favourable Opinion