NCT05522920尚未招募不适用
Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Acceptance
研究概览
简要总结
The purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Willing and able to give informed consent for participation in the study
- •Aged ≥18 years
- •Injury level C3-C7, American Spinal Cord injury Association Impairment Scale (ASIA) A
- •≥1 year post-injury
- •Medically stable, cognitively intact, and able to breathe independently
- •Able to attend all sessions two or three times per week, for 2 h sessions and assessments
排除标准
- •Any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps
- •Possible, suspected, or confirmed pregnancy and/or lactation
- •Recent history or fracture, contractures or pressure sore, deep vein thrombosis (DVT) or urinary tract, or other infection that may interfere with the intervention and training
- •History of epilepsy and/or seizures
- •Severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change
- •Botulinum toxin injections within 6 months of participation
- •Non-injury related neurological impairment
- •Clinically significant severe depression in spite of treatment
- •Cardiovascular disease
- •Autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month
- •Skin conditions or allergies that may affect electrode placement
- •Do not understand English
- •Received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval.
- •Involved in any other study involving stimulation of the spinal cord within 6 months of enrolment
- •Information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant
结局指标
主要结局
Acceptance
时间窗: 26 weeks at the end of intervention
Whether the treatment protocol is acceptable by people with complete tetraplegia. This will be assessed using semi structured interview results of which will be analysed qualitatively to determine the number of participants who would use the therapy on an ongoing basis.
次要结局
- Neurophysiological change(26 and 38 weeks, at the end of intervention and at follow up respectively)
- Autonomic function(26 weeks at the end of intervention)
- Change in perceived health status(26 weeks at the end of intervention)
- Sensation(26 weeks at the end of intervention)
- Spasticity(26 weeks at the end of intervention)
- Clinical effectiveness of spinal cord stimulation using GRASSP tool(26 and 38 weeks, at the end of intervention and at follow up respectively)
研究者
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