Exploring the Effects of Neurofeedback on Spasticity and Motor Function in Individuals With Subacute and Chronic Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
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.
详细描述
The proposed study is a pilot exploratory study. It will be carried out on 20 chronic and sub-acute incomplete spinal cord injury participants who will receive five sessions of neurofeedback treatment, over two weeks. The duration and number of sessions is based on previous studies in which participants learned neurofeedback strategies after two practice sessions.
People who decide to take part will be assigned to one of the following groups: subacute lower limb (sLL), subacute upper limb (sUL), chronic lower limb (cLL) or chronic - upper limb (cUL). We will use existing clinical American Spinal Injury Association (ASIA) testing information to assess the level and completeness of injury, i.e. we will gain this information from patient notes following assessment performed by the healthcare professional.
The groups will undergo similar therapy sessions. The intervention comprises the same task - neurofeedback, or modulation of brain oscillations. However, the location of modulation will differ between UL and LL groups because different parts of the brain are responsible for arm and leg function. Participants in the subacute groups (sUL, sLL) will attend two additional assessments as their baseline condition might change from week to week. Due to the nature of exploratory studies, the assessments presented for each group are necessary to determine accurately the effect of neurofeedback on motor function. Therefore, assessments presented for each session are compulsory.
The subjects will receive the intervention therapy independent of any routine therapy session at Queen Elizabeth National Spinal Injuries Unit (QENSIU). The sessions will occur within the same 2-hour time window, as much as possible, to prevent normal diurnal variation in biophysical parameters (brain signatures, spasms).
Recruitment: The total number of patients admitted to the QENSIU with incomplete injury in 2019-20 was 105, comprising 69 cervical level (C1-C8), 22 thoracic level (T1-T12) and 13 lumbar level (L1-L5) with a mean length of stay of 38 days (5 weeks). The out-patient activity of the Unit: in 2019-20, 1551 individuals returned for post-discharge management of their injury and 70 new outpatients were accepted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for subacute upper limb:
- •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
- •Inclusion Criteria for chronic upper limb:
- •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
- •Inclusion Criteria for subacute lower limb:
- •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 T1 to L1
- •Normal or corrected to normal vision
- •Ability to walk > 10 meters (assisted or unassisted), if ASIA level D
- •Spasticity equivalent of MAS level 1+ and above
- •Inclusion Criteria for chronic lower limb:
- •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 T1 to L1
- •Normal or corrected to normal vision
- •Ability to walk > 10 meters (assisted or unassisted), if ASIA level D
- •Spasticity equivalent of MAS level 1+ and above
- •Live in Greater Glasgow and Clyde area
排除标准
- •Exclusion Criteria for subacute groups:
- •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
- •Exclusion Criteria for chronic groups:
- •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
- •Live outside Greater Glasgow and Clyde area
结局指标
主要结局
Modified Ashworth Scale
时间窗: 4 weeks
Improvements in spasticity in the upper or lower limb (UL, LL groups) after neurofeedback sessions
次要结局
- 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)