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临床试验/NCT07619300
NCT07619300尚未招募不适用

Pilot Study: Dorsal Root Ganglion Stimulation After Spinal Cord Injury-Related Lower Motor Neuron Damage

Peter J. Grahn, Ph.D.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2026年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1
试验地点
1

研究概览

简要总结

The purpose of this study is to study sensorimotor circuit activity generated in response to temporarily implanted dorsal root ganglion stimulation by recording from muscles of the lower extremities as well as functional outcomes achieved over a 10-day rehabilitation program in an individual with lower motor neuron 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
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatic and non-traumatic spinal cord injury (SCI)
  • ASIA Impairment Scale (AIS) A-D
  • SCI below the tenth thoracic vertebral level
  • Greater than 1 year post-SCI
  • Intact spinal reflexes at or below injury level in 1 or more muscles

排除标准

  • Currently a prison inmate, or awaiting trial, related to criminal activity
  • Pregnancy at the time of screening for trial enrollment
  • Active, untreated urinary tract infection
  • Unhealed decubitus ulcer
  • Unhealed skeletal fracture
  • Spinal abnormality that may impede percutaneous implantation of spinal electrodes
  • Untreated clinical diagnosis of psychiatric disorder
  • Joint contractures that impede typical range of motion
  • Non-MRI-compatible implanted medical devices
  • Other implanted stimulation devices (e.g., deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
  • Active participation in an interventional clinical trial which, based on the research team's assessment, may compromise protocol compliance, safety, and/or validity of data collected during this study
  • History of clinically diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
  • History of frequent and/or severe autonomic dysreflexia
  • History of seizure disorder
  • Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study

研究组 & 干预措施

Dorsal Root Ganglion Stimulation

Experimental

One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation.

干预措施: Abbot Dorsal Root Ganglion Neurostimulator (Device)

研究者

发起方
Peter J. Grahn, Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter J. Grahn, Ph.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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