Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI

Обзор

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.

Вмешательства

• Устройство Transcutaneous Spinal Cord Stimulation
  Non-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA and specific criteria will be followed to determine the optimal therapeutic stim
• Устройство Sham Stimulation
  Non-invasive electrical stimulation of a lower extremity muscle group over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver sham stimulation. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention.

Первичные конечные точки

• Change in systolic Blood Pressure (BP) [Срок оценки: 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.]
• Heart Rate (HR) monitoring during tSCS [Срок оценки: 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.]
• frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours. [Срок оценки: 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.]

Вторичные конечные точки (11)

• International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Repeated measures at every study visit, over a period of 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Публикации

• Nakahara R, Nasson S, Bieler E, Putsche-Young E, Aguila B, Shen J, Chung E, Winston L, Burns S, Crane D, Eugenio M, Krogh K, Krassioukov A, Moritz C, Samejima S. Effects of non-invasive spinal cord stimulation on autonomic function in individuals with subacute spinal cord injury: A pilot clinical trial protocol. PLoS One. 2026 Apr 20;21(4):e0347211. doi: 10.1371/journal.pone.0347211. eCollection 2 PMID 42008493

Идентификаторы

NCT: NCT06540859 · STUDY00020243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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