Neurofeedback to Improve Spasticity After Incomplete Spinal Cord Injury

Summary

After incomplete spinal cord injury (iSCI), many people still have control over their upper and/or lower limbs, but secondary conditions such as spasticity impair the function they have left. Spasticity includes increased reflex response and muscle tone, and is often painful. In this study we want to test a rehabilitation therapy to reduce spasticity after iSCI and improve participants' control over their extremities. The study involves recording participants' brain signals (EEG) and displaying them on a computer, so that they learn to control specific features derived from their brain waves. This is called neurofeedback (NF). Two studies conducted in our group that explored NF effect on central neuropathic pain in iSCI reported as incidental finding a decrease in spasms, muscle tightness and foot drop.

The effect of NF is immediate and lasts up to 24 hours. In this study, we will explore systematically the short- and medium-term effect of NF on a larger number of iSCI, to inform a potential randomized clinical trial.

Gaining control over one's brain activity requires practice and 80-90% people eventually learn the skill. Each participant will therefore attend five sessions of NF taking no longer than two hours each.

20 participants will be recruited and assigned to either upper or lower limb spasticity groups. This will allow us to determine if the mechanism of NF differs between arms and legs. Participants will be further grouped into sub-acute and chronic groups, depending on the time since injury, to pinpoint at what stage post-injury NF is the most effective.

All groups will receive the same number of NF sessions. The primary outcome of this study is the change in spasticity of the hand or leg, as measured by the Modified Ashworth Scale (MAS). Secondary outcomes include use of arm/leg, quality of life, and the relation between functional improvement and EEG changes. Outcomes will be compared before/after each session, and before/after the whole intervention period, both inter- and intra-group.

Conditions

• Incomplete Spinal Cord Injury

Interventions

OTHER

visual neurofeedback

Neurofeedback is a neuromodulatory intervention that does not require applying external stimuli. It relies on displaying participants' brain activity in real time, with the aim of modifying it. Electrical activity (EEG) will be recorded from participants and displayed in real time on a computer screen, in the form of three bars. They will be asked to increase the middle bar, while keeping the side bars low. The intervention requires training to achieve voluntary control of the targeted brain activity.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde

  lead OTHER

Principal Investigators

• Mariel Purcell, MD · NHS Greater Galsgow and Clyde

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-31

Primary Completion

2023-05-31

Completion

2023-07-31

Countries

• United Kingdom

Study Locations