Neurofeedback to Improve Spasticity After Incomplete Spinal Cord Injury

NCT04849676 | Unknown

• 2 other identifiers: GN20NE696288894
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  Improvements in spasticity in the upper or lower limb (UL, LL groups) after neurofeedback sessions

  4 weeks

Secondary Outcomes (3)

• Functional improvements

  4 weeks

• Participant experience

  1 hour; after the last experimental session

• Correlation between EEG activity and functional improvements

  one day to one month after the last experimental session, off line quantitative analysis

Study Arms (4)

Upper limb subacute spinal cord injury (sUL)

EXPERIMENTAL

Intervention: neurofeedback. Participants will receive visual feedback on a screen. Diagnostic Tests: Modified Ashworth Scale grading muscle resistance to movement (all limbs tested) Perceived Spasticity level questionnaire on impact of spasticity Spinal Cord Independence Measure questionnaire on level of independence of patients Diary of spastic episodes Grip strength - measure of hand and forearm muscle strength using dynamometer Instrumented Pendulum test - oscillations when forearm is dropped from a resting position Hand grip - closing and opening the fist recorded with Kinect (Microsoft) device EEG recording in relaxed state with bioamplifier g.usbamp (Guger Technologies, Austria) Brief Visual Analog Scale self-assessment of performance and mental strategies Motor evoked potential - effect of therapy on the descending path from brain to spinal cord with a transcranial magnetic stimulator (200-2, Magstim Co Ltd)

Other: visual neurofeedback

Upper limb chronic spinal cord injury (sUL)

EXPERIMENTAL

Intervention: neurofeedback. Participants will receive visual feedback on a screen. Diagnostic Tests: Modified Ashworth Scale grading muscle resistance to movement (all limbs tested) Perceived Spasticity level questionnaire on impact of spasticity Spinal Cord Independence Measure questionnaire on level of independence of patients Diary of spastic episodes Grip strength - measure of hand and forearm muscle strength using dynamometer Instrumented Pendulum test - oscillations when forearm is dropped from a resting position Hand grip - closing and opening the fist recorded with Kinect (Microsoft) device EEG recording in relaxed state with bioamplifier g.usbamp (Guger Technologies, Austria) Brief Visual Analog Scale self-assessment of performance and mental strategies Motor evoked potential - effect of therapy on the descending path from brain to spinal cord with a transcranial magnetic stimulator (200-2, Magstim Co Ltd)

Other: visual neurofeedback

Lower limb subacute spinal cord injury (sLL)

EXPERIMENTAL

Intervention: neurofeedback. Participants will receive visual feedback on a screen. Diagnostic Tests: Modified Ashworth Scale grading muscle resistance to movement (all limbs tested) Perceived Spasticity level questionnaire on impact of spasticity Spinal Cord Independence Measure questionnaire on level of independence of patients Diary of spastic episodes Instrumented Pendulum test - oscillations when lower leg is dropped from a resting position 10m walking test - patient walks 10 meters in a straight line, recorded with Kinect (Microsoft) device EEG recording in relaxed state with bioamplifier g.usbamp (Guger Technologies, Austria) Brief Visual Analog Scale self-assessment of performance and mental strategies Motor evoked potential - effect of therapy on the descending path from brain to spinal cord with a transcranial magnetic stimulator (200-2, Magstim Co Ltd)

Other: visual neurofeedback

Lower limb chronic spinal cord injury (cLL)

EXPERIMENTAL

Intervention: neurofeedback. Participants will receive visual feedback on a screen. Diagnostic Tests: Modified Ashworth Scale grading muscle resistance to movement (all limbs tested) Perceived Spasticity level questionnaire on impact of spasticity Spinal Cord Independence Measure questionnaire on level of independence of patients Diary of spastic episodes Instrumented Pendulum test - oscillations when lower leg is dropped from a resting position 10m walking test - patient walks 10 meters in a straight line, recorded with Kinect (Microsoft) device EEG recording in relaxed state with bioamplifier g.usbamp (Guger Technologies, Austria) Brief Visual Analog Scale self-assessment of performance and mental strategies Motor evoked potential - effect of therapy on the descending path from brain to spinal cord with a transcranial magnetic stimulator (200-2, Magstim Co Ltd)

Other: visual neurofeedback

Interventions

visual neurofeedback OTHER

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.

Lower limb chronic spinal cord injury (cLL); Lower limb subacute spinal cord injury (sLL); Upper limb chronic spinal cord injury (sUL); Upper limb subacute spinal cord injury (sUL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged above 18
• Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI
• Injury occurred no more than six months prior to participation in the study
• Injury level C3 to C7
• Normal or corrected to normal vision
• Spasticity equivalent of MAS level 1+ and above
• Aged above 18
• Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI
• Injury occurred more than one year prior to participation in the study
• Injury level C3 to C7
• Normal or corrected to normal vision
• Spasticity equivalent of MAS level 1+ and above
• Live in Greater Glasgow and Clyde area
• Aged above 18
• Incomplete injury to the spinal cord, resulting in ASIA level C or D SCI

You may not qualify if:

• Participation in any other neurofeedback intervention group
• Inability to understand the task
• Self-reported neurological disorders e.g. previously confirmed peripheral nerve injury or brain injury
• General poor health due to secondary consequences of injury
• Conditions contra-indicative of neurostimulator usage (implanted devices, sensitive skin sores in the upper and lower extremities, pregnancy, severe autonomic dysreflexia)
• History of epilepsy
• Inability to sit for 1.5 hours
• Inability to speak and/or understand English
• Participation in any other neurofeedback intervention group
• Inability to understand the task
• Self-reported neurological disorders e.g. previously confirmed peripheral nerve injury or brain injury
• General poor health due to secondary consequences of injury
• Conditions contra-indicative of neurostimulator usage (implanted devices, sensitive skin sores in the upper and lower extremities, pregnancy, severe autonomic dysreflexia)
• History of epilepsy
• Inability to sit for 1.5 hours

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Queen Elizabeth University Hospital, Queen Elizabeth National Spinal Injurie Unit

Glasgow, Glasgow City, G51 4TF, United Kingdom

RECRUITING

Study Officials

• Mariel Purcell, MD

  NHS Greater Galsgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Vuckovic, PhD

CONTACT

07906441955; Aleksandra.Vuckovic@glasgow.ac.uk

Mariel Purcell, MD

CONTACT

01412012536; margaret.purcell@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 19, 2021
• Study Start: August 31, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study end (March 2023)
• Access Criteria: Data will be shared upon reasonable request

Locations

GB (1)