Clinical trial NCT06540859: Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
Official title: Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Transcutaneous Spinal Cord Stimulation
Inpatient Rehabilitation
Cardiovascular Recovery following SCI
Bladder and Bowel Recovery following SCI
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2024-08-06
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Have autoimmune etiology of spinal cord dysfunction/injury
2. Have history of additional neurologic disease, such as stroke, MS, etc.
3. Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
4. Are ventilator dependent.
5. Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
6. 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.
7. Have Intrathecal baclofen pump.
8. Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
9. 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.
10. 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.
11. Are a member of the investigational team or his/her immediate family.
12. Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
13. Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
14. Have a history of seizures.

Primary outcomes:
measure: Change in systolic Blood Pressure (BP)
timeFrame: 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.
measure: Heart Rate (HR) monitoring during tSCS
timeFrame: 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.
measure: frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours.
timeFrame: 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:
measure: International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
timeFrame: 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.
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: 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.
measure: Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
timeFrame: 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.
measure: Numeric Pain Rating Scale
timeFrame: 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.
measure: International SCI Pain Basic Dataset
timeFrame: 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.
measure: Neurogenic Bladder Symptom Score
timeFrame: 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.
measure: International SCI Lower Urinary Tract Function Basic Data Set (ISNCSCI)
timeFrame: 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.
measure: International SCI Bowel Function Basic Data Set (ISCIBFDS)
timeFrame: 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.
measure: Colonic Transit Time
timeFrame: 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.
measure: Changes in Lower Urinary Tract and Bowel Function
timeFrame: Post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at 2 timepoints over 6 months.
measure: Frequency and Severity of Adverse Events
timeFrame: Repeated measures at every study visit, over a period of 6 months.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Soshi Samejima, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: