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

NCT06540859 | Recruiting DMC

• 1 other identifier: STUDY00020243
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Spinal Cord Injuries

Keywords

Transcutaneous Spinal Cord Stimulation; Inpatient Rehabilitation; Cardiovascular Recovery following SCI; Bladder and Bowel Recovery following SCI

Outcome Measures

Primary Outcomes (3)

• Change in systolic Blood Pressure (BP)

  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.

  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

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

  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.

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

  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.

Secondary Outcomes (11)

• 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.

Study Arms (2)

Transcutaneous Spinal Cord Stimulation

EXPERIMENTAL

Device: Transcutaneous Spinal 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

Device: Transcutaneous Spinal Cord Stimulation

Sham stimulation

SHAM COMPARATOR

Device: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. 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.

Device: Transcutaneous Spinal Cord Stimulation; Device: Sham Stimulation

Interventions

Transcutaneous Spinal Cord Stimulation DEVICE

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 stimulation.

Also known as: tSCS

Sham stimulation; Transcutaneous Spinal Cord Stimulation

Sham Stimulation DEVICE

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.

Sham stimulation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Soshi Samejima, DPT, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soshi Samejima, DPT, PhD

CONTACT

2066160462; soshis@uw.edu

Katie Singsank, BA

CONTACT

singsank@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: Department of Rehabilitation Medicine

Model Details: randomized, single-blind, two-arm sham-controlled clinical trial with two arms (tSCS compared to sham-stimulation) and two parts (Part A and Part B). Part A will be conducted while participants are staying in inpatient rehabilitation. Participants will be randomized to either tSCS or sham stimulation. Part B will take place in outpatient rehabilitation medicine and all participants will receive tSCS stimulation for up to 18 sessions.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: August 6, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)