Spinal Cord InjuriesNCT06313515
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
A study testing Transcutaneous Spinal Cord Stimulation and Arm-crank bike exercise in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
Trial summary
Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous Spinal Cord Stimulation and Arm-crank bike exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Feb 2027
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Soshi Samejima, DPT, PhD
About this study
Official title: Transcutaneous Spinal Cord Stimulation Combined With Arm Crank Exercise for Cardiovascular Recovery in Cervical and Upper Thoracic SCI
Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).
The main questions the study aims to answer are:
Read more
- Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.
- Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.
- Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.
- Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.
Participants will:
- Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.
- Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.
- During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Assessment procedures also include stool sample and nasal swab collection.
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcutaneous Spinal Cord Stimulation, Arm-crank bike exercise, Sham Stimulation
- Keywords
- Transcutaneous Spinal Cord Stimulation, Arm-Bike Exercise, Cardiovascular Function
- 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.
Transcutaneous Spinal Cord StimulationDevice
Also called tSCS
Non-invasive electrical stimulation of the spinal cord over the skin
Arm-crank bike exerciseBehavioural
Also called arm-crank exercise
Exercise using an arm-bike to target cardiovascular functioning.
Sham StimulationOther
Non-invasive electrical stimulation of a lower extremity muscle group over the skin.
| Study group | Role | What they receive |
|---|---|---|
| tSCS paired with arm-crank exercise | Experimental | Device: Transcutaneous Spinal Stimulation
Non-invasive electrical stimulation of the spinal cord over the skin.
Other: Arm-crank exercise
Exercise using an arm-bike to target cardiovascular functioning. Receives: Device: Transcutaneous Spinal Cord Stimulation; Behavioral: Arm-crank bike exercise |
| Sham stimulation paired with arm-crank exercise | Sham comparator | Device: Sham Stimulation
Non-invasive electrical stimulation of a lower extremity muscle group over the skin.
Other: Arm-crank exercise
Exercise using an arm-bike to target cardiovascular functioning. Receives: Device: Transcutaneous Spinal Cord Stimulation; Behavioral: Arm-crank bike exercise; Other: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic Blood Pressure (BP) from baseline.
Continuous beat-by-beat BP will be measured using a finger photoplethysmography.
Measured: Baseline
Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Continuous beat-by-beat BP will be measured during a orthostatic challenge.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Heart rate variability recorded by electrocardiogram (ECG).
Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Secondary outcomes (10)
Peak oxygen uptake (VO2peak)
Measured during incremental cardiopulmonary exercise test (CPET) on the arm-crank.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
The Autonomic Dysfunction following SCI (ADFSCI) measure will be used to assess severity and frequency of autonomic dysreflexia. Greater scores equal greater frequency of autonomic dysfunction, ranging from 0 (never) to 4 (very often) for each item.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Standards for Neurological Classification of Spinal Cord Injury
level and severity of damage to motor and sensory pathways will be determined by trained clinicians. Pin prick and light touch will be done by researchers on participant's left and right side. Check marks are given for each prick or touch that is felt by the participant, then tallied. Scores range from 0-56 for both the Left and Right side of the body, and 0-112 for the total score. High scores represent greater sensory functioning.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Scores for questions on the ISAFSCI range from 0 to 2, with 0 representing complete loss of control and 2 representing normal functioning. Lower scores equal worse health functioning.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Blood Pressure variability
BP Variability will be assessed using results from continuous beat-by-beat BP measurements obtained throughout the study using Finapres NOVA and a 24 hour BP monitoring assessment.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2
Measurement of upper limb strength, sensation, qualitative prehension, and quantitative prehension (range 0-188, higher score mean better outcome)
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Change from baseline- Capabilities of Upper Extremity Test
Measures unilateral and bilateral hand and arm function (range 0-128, higher score mean better outcome)
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Pain Basic Dataset version 2.0
Standardized questionnaire for the collection and reporting of pain in the SCI population. Scores range from 0 to 10, with higher scores indicating greater pain interference and worse functioning.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Lower Urinary Tract Function Dataset
The International SCI Lower Urinary Tract Function Dataset is a data collection form for the collection and reporting of lower urinary tract function in the SCI population. Participants are asked to mark either main or supplementary for type of bladder emptying, and then answer yes or no questions regarding type of appliances used to collect urinary incontinence, drugs with possible influence on urinary tract within the past 4 weeks, and any surgical procedures on the urinary tract. This data collection form does not use numbers and instead collects qualitative data only; there is no score range.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Bowel Function Dataset
Standardized data collection form for the collection and reporting of bowel function in the SCI population. The International SCI Bowel Function Dataset is a data collection instrument that asks participants qualitative questions which are assigned a score. Select items are then totaled to compute the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0 to 14 or more, with higher scores indicating greater neurogenic bowel dysfunction.
Measured: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soshi Samejima, University of Washington
- Investigators
- Soshi Samejima, DPT, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313515
- Sponsor's protocol ID
- STUDY00019529
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation Combined With Arm Crank Exercise for Cardiovascular Recovery in Cervical and Upper Thoracic SCI
- ClinicalTrials.gov ID
- NCT06313515
- Acronym / sponsor ID
- STUDY00019529
- Conditions
- Spinal Cord Injuries
- Keywords
- Transcutaneous Spinal Cord Stimulation, Arm-Bike Exercise, Cardiovascular Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).
The main questions the study aims to answer are:
- Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.
- Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.
- Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.
- Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.
Participants will:
- Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.
- Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.
- During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Assessment procedures also include stool sample and nasal swab collection.
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| tSCS paired with arm-crank exercise | Experimental | Device: Transcutaneous Spinal Cord Stimulation, Behavioral: Arm-crank bike exerciseDevice: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning. |
| Sham stimulation paired with arm-crank exercise | Sham comparator | Device: Transcutaneous Spinal Cord Stimulation, Behavioral: Arm-crank bike exercise, Other: Sham StimulationDevice: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 StimulationAlso: tSCSNon-invasive electrical stimulation of the spinal cord over the skin | Device | Sham stimulation paired with arm-crank exercise, tSCS paired with arm-crank exercise |
| Arm-crank bike exerciseAlso: arm-crank exerciseExercise using an arm-bike to target cardiovascular functioning. | Behavioural | Sham stimulation paired with arm-crank exercise, tSCS paired with arm-crank exercise |
| Sham StimulationNon-invasive electrical stimulation of a lower extremity muscle group over the skin. | Other | Sham stimulation paired with arm-crank exercise |
Primary outcome
Change in systolic Blood Pressure (BP) from baseline.
Time frame: Baseline
Continuous beat-by-beat BP will be measured using a finger photoplethysmography.
Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Continuous beat-by-beat BP will be measured during a orthostatic challenge.
Heart rate variability recorded by electrocardiogram (ECG).
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.
10 secondary outcomes
Peak oxygen uptake (VO2peak)
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Standards for Neurological Classification of Spinal Cord Injury
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Blood Pressure variability
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Change from baseline- Capabilities of Upper Extremity Test
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Pain Basic Dataset version 2.0
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Lower Urinary Tract Function Dataset
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
International Spinal Cord Injury Bowel Function Dataset
Time frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months
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 6 May 2026.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Soshi Samejima, DPT, PhD principal investigator
University of Washington
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 and Arm-crank bike exercise in people with Spinal Cord Injuries, run by University of Washington 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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 May 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?
Contact Soshi Samejima, DPT, PhD (2066160462, soshis@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic Blood Pressure (BP) from baseline. (time frame: Baseline). 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 6 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.