Electroencephalographic Predictors of Central Neuropathic Pain in Subacute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- EEG based classifier of pain
研究概览
简要总结
Spinal cord injury (SCI), induced by damage to the spinal cord, can cause life-altering levels of disability including the development of chronic pain. Central Neuropathic Pain (CNP) typically develops within months after injury in 40-50% of SCI patients, affecting everyday activity, sleep and mood. There is no cure for CNP, it can be very difficult to treat and is often refractory to any pharmacological treatments.
In a previous study (study no. 14/WS/1029) the principle investigators showed that the likelihood of CNP developing can be predicted by defining characteristics of brain waves that are related to pain. We will use electroencephalograph (EEG) to measure brain activity in people early after SCI, before they develop pain, knowing that about half will develop pain within a year. We aim to recruit 80 participants, aged 18-80; 40 with subacute spinal injury (level C3-T12) and no symptoms of CNP; 20 with symptoms of CNP and 20 able-bodied participants. Completeness of injury is irrelevant. Patients will be recruited by clinical consultants within national spinal units in Glasgow and Stoke Mandeville. Patients will undergo two EEG recording sessions in which they will imagine movements while we record EEG. Sessions will also involve basic sensory testing and completion of questionnaires. Able-bodied participants will be recruited by the Philosophy Doctor (PhD) candidate at the University of Glasgow and undergo only one EEG session (identical to SCI patients).
The primary aim of this study is to use early EEG markers of CNP to optimise and validate an existing computer program based on machine learning to enable more accurate prediction of pain in newly injured patients with the hope of aiding future treatments. Secondary aims include characterising EEG features which might describe different phases in patients' development of CNP and exploring possible differences between pain at/below the level of SCI based on EEG markers.
详细描述
Study Design The proposed study will be a longitudinal cohort study in which participants will attend one assessment session as inpatients in the subacute stage and a further assessment six months later, during which time patients are likely to be outpatients. Each session will last up to two hours and questionnaires may be completed within the hospital or outside. To minimise the drop-out, patients will be followed-up though their regular visits to the Queen Elizabeth National Spinal Injuries Uni (QENSIU) or Stoke Mandeville National Spinal Injuries Centre (NSIC) to categorise occurrence of pain, based on the recommended criteria for CNP and the International Spinal Cord Injury Pain Classification System. For those unable to attend the follow-up session, Co-Investigators will take information from their patient notes about their pain, allodynia and hyperalgesia in order to ensure that pain status is collected twice for all participants.
The study will be carried out on 20 able bodied and 60 subacute SCI patients, 40 with no CNP, and 20 with CNP (refer to section 8 for group size considerations). All patients will attend two recording sessions, 2 hours in length, during which time they will undergo EEG recordings as well as sensory testing (including mechanical and thermal tests). This is based on protocol used with the previous cohort. The first test will be carried out as soon as the patients' health condition allows them to sit for the duration of the experiment (this could be within first 3-6 months post injury as Stoke Mandeville Natioanl Spinal Injury Centre (NSIC) does not admit any early injury patients) and the second assessment will take place approximately 6 months later. Able-bodied participants will attend only one session.
Recruitment QENSIU admits around 110 new patients annually whilst Stoke Mandeville Hospital admits around 200. This gives 600 potential volunteers over a 2 year period which should be sufficient to recruit the targeted number. It is planned to recruit approximately half of participants (around 30 people with SCI) from each centre.
Patients will be identified and approached by their clinical consultants (Co-Investigators Dr Mariel Purcell and Dr Maurizio Belci). Prior to participating, patients will be given information sheets and consent forms to sign and should the participant themselves be unable to physically sign, a witnessed proxy can do so on the patient's behalf.
Able bodied participants will be recruited by advertising the study at the University of Glasgow and their data will be collected within the University of Glasgow Rehabilitation Engineering laboratory on University Campus. They will be recruited by the PhD student.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for patients with SCI and NO chronic pain are as follows:
- •Age between 18-80
- •Subacute spinal cord injury (within 6 months post injury)
- •Level C3-T12
- •ASIA A, B, C or D
- •Normal or corrected to normal vision
- •No allodynia or hyperalgesia
- •Inclusion criteria for patients with SCI and CNP are as follows:
- •Age between 18-80
- •Subacute spinal cord injury (within 6 months of injury)
- •Level C3-T12
- •ASIA A, B, C or D
- •Normal or corrected to normal vision
- •Presence of allodynia or hyperalgesia
- •Diagnosed CNP related to SCI equal or larger than 4 on visual numerical scale (VNS)
- •Inclusion criteria for able-bodied participants:
- •Age 18-80
- •No self-reported neurological conditions
- •No chronic or acute pain equal or larger than 3 on VNS
- •Normal or corrected to normal vision
- •English speaker
排除标准
- •Exclusion criteria for patients with and without CNP:
- •Inability to understand the task
- •Inability to sit for at least 2 hours (duration of EEG assessment)
- •Invasive 24/7 ventilation
- •Previously confirmed brain injury, (peripheral nerve injury and brachial plexus injury)
- •Other self-reported neurological condition that would affect EEG recording
- •Presence/history of any other chronic or acute pain (larger or equal to 3 on the VNS)
- •Pressure sores or any other condition that might prevent sitting for 2 hours
- •Halos or neck support that prevent EEG recording
- •Infections of the skin or communicable diseases (e.g. hospital bugs)
- •Concurrent acute medical problems (e.g. infections)
- •Infection control issues i.e. the need for patient isolation
- •Do not understand English
- •Able bodied people and people who had spinal cord injury and are still in subacute phase (6 monthExclusion Criteria for able-bodied participants:
- •Unable to give informed consent
- •Presence of chronic or acute pain equal to or larger than 3 on VNS
- •Any self-reported neurological conditions
- •Non-English Speaker s post injury)
结局指标
主要结局
EEG based classifier of pain
时间窗: All groups EEG recording upon recruitment
Create a software application that can classifify between people with SCI and healthy people and people with SCI with and without pain based on EEG markers
Changes in EEG
时间窗: EEG recording upon recruitment and EEG recording six month later in all groups of people with SCI
Difference between baseline EEG and EEG recorded six months later
次要结局
- EEG markers of different phased of SCI(Fist EEG recording upon recruitment, second six month later)
- Correlation between sensory and neurological test and questionnaires(Fist EEG recording, sensory test and questionnaires uppon recruitment, second six month later)
- EEG markers of at level and below level pain(Fist EEG recording upon recruitment, second six month later)