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Spinal stimulation plus arm biking may steady blood pressure after injury

NCT ID NCT06313515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive spinal cord stimulation device, used while exercising on an arm bike, can improve blood pressure and heart function in people with chronic spinal cord injury. Sixteen adults with paralysis at or above the T6 level will receive either real or sham stimulation during 8 weeks of exercise. Researchers will measure changes in blood pressure, heart rate variability, and exercise capacity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous spinal cord stimulation (tSCS)
What this could lead to
If it works, this could lead to a non-invasive way to help people with spinal cord injury better control their blood pressure and heart function, making daily activities easier.
What could go wrong
This is a small, early-stage trial with only 16 participants, so results may not apply to everyone. The stimulation is non-invasive but may not produce lasting benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Are between 21-65 years of age. * Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment. * Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery. * American Spinal Injury Association Impairment Scale (AIS) A, B for SCI. * Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities. * Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.) * Willing and able to comply with all clinic visits and study-related procedures. * Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator). * Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing. * Are with stable management of spinal cord related clinical issues (i.e., spasticity management). * Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: -----Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence. * Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment. * Are volunteering to be involved in this study. * Has adequate social support to be able to participate in training and assessment sessions, up to 3 sessions per week, for the duration of up to 6 months within the study period. * Must provide informed consent. Exclusion Criteria: * Have autoimmune etiology of spinal cord dysfunction/injury * Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc. * Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, 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, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, 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. * Take more than 40 mg of Baclofen per day * Have severe anemia (Hgb\<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months. * Are a member of the investigational team or his/her immediate family. * Have undergone electrode implantation surgery. * Have signs of lower motor neuron impairment (i.e., concomitant conus medullaris/cauda equina injury). * 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. * Have chronic headaches or migraines.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

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