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临床试验/NCT06540859
NCT06540859招募中不适用

[Trial of device that is not approved or cleared by the U.S. FDA]

[Redacted]2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年12月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
试验地点
2
主要终点
Change in systolic Blood Pressure (BP)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs. We will also examine the effect of tSCS on lower urinary tract (LUT) and bowel functions as secondary outcomes.

The main questions this study aims to answer are:

  1. Assess the safety of single and repeated tSCS session(s) on cardiovascular function in the acute SCI: We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge (i.e., situ-up tests) at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI ≥ T6.
  2. Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase: We will investigate the efficacy of long-term (total 18 sessions) tSCS on cardiovascular and pelvic organ functions.
  3. Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI: We will assess the sustained effect of repeated tSCS sessions (18 sessions) on cardiovascular and pelvic organ functions at 6-month post-SCI.

Participants will:

  • Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while inpatient in the first 8 weeks (Part A).
  • Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks (Part B), with a follow-up period of 6 months. All participants will receive tSCS during this outpatient follow-up portion of the study.
  • During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, bladder and bowel, physical, and autonomic exam, and will ask questions about quality of life and functioning. Participants will be asked to complete a test of how well their bowels are functioning (colonic transit test) and an abdominal X-Ray.

Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the body's autonomic functioning following recent-onset SCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Are between 21-65 years of age.
  • •SCI (non-progressive) at or above the T6 spinal segment.
  • •Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
  • •American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
  • •Have stable medical condition that would permit participation in testing activities.
  • •Willing and able to comply with all clinic visits and study-related procedures.
  • •Able to understand and complete study-related questionnaires in English.
  • •Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
  • •Are not currently pregnant or not intending to become pregnant during participation in this study.
  • •Are volunteering to be involved in this study.
  • •Must provide informed consent.

排除标准

  • •Have autoimmune etiology of spinal cord dysfunction/injury
  • •Have history of additional neurologic disease, such as stroke, MS, etc.
  • •Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • •Are ventilator dependent.
  • •Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
  • •Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
  • •Have Intrathecal baclofen pump.
  • •Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
  • •Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, or unstable diabetes.
  • •Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
  • •Are a member of the investigational team or his/her immediate family.
  • •Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
  • •Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
  • •Have a history of seizures.

结局指标

主要结局

Change in systolic Blood Pressure (BP)

时间窗: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.

Continuous beat-by-beat BP will be measured using a finger photoplethysmography. This will be done throughout the study, including during orthostatic challenge using sit-up test.

Heart Rate (HR) monitoring during tSCS

时间窗: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.

Electrocardiography (ECG) at resting and during sit-up test

frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours.

时间窗: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.

24-hour BP monitoring obtained throughout the study using Finapres NOVA

次要结局

  • International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • International Standards for Neurological Classification of Spinal Cord Injury(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • Numeric Pain Rating Scale(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • International SCI Pain Basic Dataset(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • Neurogenic Bladder Symptom Score(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • International SCI Lower Urinary Tract Function Basic Data Set (ISNCSCI)(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • International SCI Bowel Function Basic Data Set (ISCIBFDS)(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • Colonic Transit Time(Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.)
  • Changes in Lower Urinary Tract and Bowel Function(Post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at 2 timepoints over 6 months.)
  • Frequency and Severity of Adverse Events(Repeated measures at every study visit, over a period of 6 months.)

研究者

发起方
[Redacted]

研究点 (2)

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