Acute Spinal Cord InjuryNCT06000592
Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
A study testing Digitimer in people with Acute Spinal Cord Injury and Spinal Cord Injuries, run by Jill M. Wecht, Ed.D. at 1 site in United States.
Trial summary
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation
- What is being tested?
- Digitimer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly injured patients with traumatic SCI
- Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- Within one year of SCI
- Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
- Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
- Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
- At least 14 years old
Who cannot join
- Implanted brain/spine/nerve stimulators
- Cochlear implants
- Cardiac pacemaker/defibrillator, or intracardiac lines
- Open skin lesions on or near the electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
- Recent history of myocardial infarction
Show all 10Show fewer
- Insufficient mental capacity to understand and independently provide consent
- Pregnancy
- Cancer
- Deemed unsuitable by study physician
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Miguel Escalón, MD, MPH, 212-241-6321, miguel.escalon@mountsinai.org
About this study
Official title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.
Read the detailed description
Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction.
- Conditions
- Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation, Traumatic Spinal Cord Injury, Spinal Cord Stimulation, SCI - Spinal Cord Injury
- Being tested
- Digitimer
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigitimerDevice
transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous spinal stimulation | Experimental | Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position. Receives: Device: Digitimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.
Measured: Acute Inpatient Rehabilitation following SCI (up to 4 months)
The safety (#1) of TSCS to improve autonomic control following acute SCI.
Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
Measured: Acute Inpatient Rehabilitation following SCI (up to 4 months)
The safety (#2) of TSCS to improve autonomic control following acute SCI.
Document any skin changes (burns) following use of TSCS in count of occurrences.
Measured: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Secondary outcomes (1)
The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation..
Measured: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jill M. Wecht, Ed.D.
- Sponsor type
- US federal agency
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Thomas N Bryce, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000592
- Sponsor's protocol ID
- 1648740
- Status last verified
- Apr 2024
- First submitted
- 23 Jun 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06000592
- Acronym / sponsor ID
- 1648740
- Conditions
- Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation, Traumatic Spinal Cord Injury, Spinal Cord Stimulation, SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jill M. Wecht, Ed.D.US federal agency
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.
Detailed description
Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcutaneous spinal stimulation | Experimental | Device: DigitimerTranscutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Newly injured patients with traumatic SCI
- Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- Within one year of SCI
- Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
- Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
Key exclusion criteria (10 listed)
- Implanted brain/spine/nerve stimulators
- Cochlear implants
- Cardiac pacemaker/defibrillator, or intracardiac lines
- Open skin lesions on or near the electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitimertranscutaneous spinal cord stimulation for blood pressure control following spinal cord injury. | Device | transcutaneous spinal stimulation |
Primary outcome
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
Time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.
The safety (#1) of TSCS to improve autonomic control following acute SCI.
Time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
The safety (#2) of TSCS to improve autonomic control following acute SCI.
Time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Document any skin changes (burns) following use of TSCS in count of occurrences.
1 secondary outcome
The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
Time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas N Bryce, MD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitimer in people with Acute Spinal Cord Injury and Spinal Cord Injuries, run by Jill M. Wecht, Ed.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Chavez, BS ((914)343-0713, jorge.chavez2@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy (#1) of TSCS to improve autonomic control following acute SCI. (time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.