NCT07109804招募中不适用
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in walking speed measured by 10-meter walk test
研究概览
简要总结
This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord injury (SCI). The purpose of this study is to assess the feasibility and inform on the safety, and efficacy of CnF DBS to improve gait in SCI patients with incomplete injury who cannot effectively walk overground
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between ages of 22-70
- •At least 1 year post SCI
- •Confirmed SCI according to SCI clinician according to clinical history and the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) / American Spinal Injury Association (ASIA) criteria as documented in the American Spinal Injury Association Impairment Scale (AIS) on examination. Other disorders of gait will be excluded by history and a neurological examination.
- •Persons with incomplete injury grades of ASIA C or D who can stand with support and who have some voluntary leg function and a maximum walking capacity of Walking Index for spinal cord injury - level II (WISCI-II) level 9 or less.
- •Injury level T10 and above.
- •Ability to stand with moderate body weight support for at least 5 minutes.
- •Stable medical and physical condition.
- •Able to commit to training/evaluation sessions over 6 months and for longer periodic follow-up.
排除标准
- •Individuals with high-moderate to severe depression -Beck Depression Inventory II (BDI II) ≥ 25).
- •Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE).
- •Individuals with alcohol use disorder. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure harmful patterns of alcohol consumption over the past year. A cutoff score of 8 will be used to identify and exclude those with moderate to severe alcohol use behavior.
- •Individuals with substance abuse. The Drug Abuse Screening Test (DAST-10) will be used to identify problematic substance abuse behavior over the past year. A cutoff score of 6 will be used to identify and exclude those with moderate to severe drug use behavior.
- •The presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy as defined by past medical history and abnormal lab work at the investigator/surgeon's discretion.
- •Individuals with a Berg Balance score <
- •Individuals with a history of traumatic brain injury (TBI), seizures, severe autonomic dysreflexia, dysphagia or osteoporosis.
- •History of prior intracranial surgery or known lesions.
- •Individuals that require diathermy, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or serial brain MRIs.
- •Individuals with non-MRI compatible metallic implants in their head or body, and with metallic implants and other implantable devices in the body that could be affected by DBS.
- •Individuals with active implantable devices anywhere in the body (e.g., cardiac pacemaker, defibrillator, implanted medication pump).
- •Individuals who are pregnant desire to become pregnant during the study.
- •Individuals who are breastfeeding.
- •Individuals with intractable orthostatic hypotension despite treatment.
- •Individuals with a recent history of limb fracture, ligamentous injury, active pressure sores or unstable skin structures (e.g., skin grafts and chest tubes).
研究组 & 干预措施
Deep Brain Stimulation (DBS)
Experimental
Participants will be in the DBS study group for up to 34 weeks.
干预措施: Deep Brain Stimulation (DBS) Device Implant Procedure (Procedure)
Deep Brain Stimulation (DBS)
Experimental
Participants will be in the DBS study group for up to 34 weeks.
干预措施: Deep Brain Stimulation (DBS) (Device)
Deep Brain Stimulation (DBS)
Experimental
Participants will be in the DBS study group for up to 34 weeks.
干预措施: Training Sessions (Other)
结局指标
主要结局
Change in walking speed measured by 10-meter walk test
时间窗: baseline, up to 34 weeks
The ten-meter walk test will be measured in meters/second.
Change in distance measured by 6-min walk test
时间窗: baseline, up to 34 weeks
The 6-min walk test will be measured in meters
次要结局
未报告次要终点
研究者
Brian Ronald Noga
Professor
University of Miami
研究点 (2)
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