Orthostatic HypotensionNCT05960448
Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
A study testing Transcutaneous Spinal Cord Stimulation (TSCS) in people with Orthostatic Hypotension, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Transcutaneous Spinal Cord Stimulation (TSCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are above the age of 18 years old
- You have an SCI between C3-T6
- You have been injured longer than 1 year
- You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
- You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
- Your prescription medications have not changed for at least 30 days
Who cannot join
- You have a history of seizures
- You have an acute illness or infection
- You have diabetes
- You have untreated thyroid disease
- You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
- You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)
Show all 13Show fewer
- You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment
- You have a present or history of a psychological disorder
- You have contraindications to electricity over your spine
- You are dependent on a ventilator to breathe or have an open tracheostomy site
- You have a recent history of substance abuse (within the past 3 months)
- You have open wounds over the spine at the level targeted for stimulation
- You are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:
- What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI?
- What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.
Read more
Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.
Please note that there no expected long term benefits of this study.
Read the detailed description
The purpose of the first part of this research study is to determine the effects of active transcutaneous spinal cord stimulation (TSCS) targeted for blood pressure (BP) control on exercise endurance time and heart rate (HR) recovery time during an arm cycle test. The results will help guide experimental studies aimed at improving exercise, rehabilitation, health, and longevity in the SCI population. If the participant chooses to participate in part one of this study, the participant will be asked to visit the laboratory for 2 visits that take about 3-4 hours each.
The purpose of part two of this study is to compare the effects of electricity being delivered through surface electrodes (sticky pads on the participants skin), called active transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with electricity initially turned on but then turned off) on the participants ability to 1) keep the participants body temperature stable and 2) feel comfortable, while in a cool environment (cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot and their comfort level by asking the participant to grade their thermal comfort (how comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral room (80° F) and again in the cool room with active TSCS compared to the cool room with sham TSCS. The results will help guide experimental studies aimed at improving health and longevity in the population with SCI. If the participant chooses to participate in this study, there will be 2 study visits that last about 3-4 hours each.
- Conditions
- Orthostatic Hypotension
- Being tested
- Transcutaneous Spinal Cord Stimulation (TSCS), Sham Transcutaneous Spinal Cord Stimulation
- Keywords
- neuromodulation, stimulation, exercise, hand bike, thermoregulation, cold room
- Medical subject headings
- Hypotension, Orthostatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord Stimulation (TSCS)Other
Also called transcutaneous spinal stimulation (TSS)
This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit.
Sham Transcutaneous Spinal Cord StimulationOther
Also called Sham Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Cord Stimulation
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time. Receives: Other: Transcutaneous Spinal Cord Stimulation (TSCS) |
| Sham Transcutaneous Spinal Cord Stimulation | Sham comparator | The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes. Receives: Other: Sham Transcutaneous Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Endurance Time
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Measured: During procedures (30 minutes)
Recovery Heart Rate
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Measured: During procedures (60 minutes)
Tcore
This outcome measure is measured in degrees Celsius.
Measured: During procedures (90 minutes)
Thermal Comfort
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
Measured: During procedures (90 minutes)
Secondary outcomes (2)
Workload
This outcome is measured in Watts (highest watt obtained)
Measured: End of exercise (30 minutes)
Rate of Perceived Exhaustion
This is measured on the Borg scale (06-20) higher number = harder perceived exertion
Measured: End of exercise (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start30 Jul 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, EdD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960448
- Sponsor's protocol ID
- 1727500
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT05960448
- Acronym / sponsor ID
- 1727500
- Conditions
- Orthostatic Hypotension
- Keywords
- neuromodulation, stimulation, exercise, hand bike, thermoregulation, cold room
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 25 Jul 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.
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:
- What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI?
- What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.
Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.
Please note that there no expected long term benefits of this study.
Detailed description
The purpose of the first part of this research study is to determine the effects of active transcutaneous spinal cord stimulation (TSCS) targeted for blood pressure (BP) control on exercise endurance time and heart rate (HR) recovery time during an arm cycle test. The results will help guide experimental studies aimed at improving exercise, rehabilitation, health, and longevity in the SCI population. If the participant chooses to participate in part one of this study, the participant will be asked to visit the laboratory for 2 visits that take about 3-4 hours each.
The purpose of part two of this study is to compare the effects of electricity being delivered through surface electrodes (sticky pads on the participants skin), called active transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with electricity initially turned on but then turned off) on the participants ability to 1) keep the participants body temperature stable and 2) feel comfortable, while in a cool environment (cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot and their comfort level by asking the participant to grade their thermal comfort (how comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral room (80° F) and again in the cool room with active TSCS compared to the cool room with sham TSCS. The results will help guide experimental studies aimed at improving health and longevity in the population with SCI. If the participant chooses to participate in this study, there will be 2 study visits that last about 3-4 hours each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | Other: Transcutaneous Spinal Cord Stimulation (TSCS)The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time. |
| Sham Transcutaneous Spinal Cord Stimulation | Sham comparator | Other: Sham Transcutaneous Spinal Cord StimulationThe sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- You are above the age of 18 years old
- You have an SCI between C3-T6
- You have been injured longer than 1 year
- You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
- You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
Key exclusion criteria (13 listed)
- You have a history of seizures
- You have an acute illness or infection
- You have diabetes
- You have untreated thyroid disease
- You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
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 |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation (TSCS)Also: transcutaneous spinal stimulation (TSS)This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit. | Other | Transcutaneous Spinal Cord Stimulation |
| Sham Transcutaneous Spinal Cord StimulationAlso: Sham Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Cord StimulationThis is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation. | Other | Sham Transcutaneous Spinal Cord Stimulation |
Primary outcome
Exercise Endurance Time
Time frame: During procedures (30 minutes)
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Recovery Heart Rate
Time frame: During procedures (60 minutes)
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Tcore
Time frame: During procedures (90 minutes)
This outcome measure is measured in degrees Celsius.
Thermal Comfort
Time frame: During procedures (90 minutes)
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
2 secondary outcomes
Workload
Time frame: End of exercise (30 minutes)
Rate of Perceived Exhaustion
Time frame: End of exercise (30 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jill M Wecht, EdD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Cord Stimulation (TSCS) in people with Orthostatic Hypotension, run by James J. Peters Veterans Affairs Medical Center 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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Endurance Time (time frame: During procedures (30 minutes)). The study lists 4 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 10 Aug 2026.