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New treatment option for Tetraplegia/Tetraparesis
Official title Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
ClinicalTrials.gov ID: NCT05423600
What this study is testing
- What it's testing
- The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
- Participants must have a companion that will be able to help him/her throughout the study.
- Greater than 1-year post SCI, neurologic level of C8 or above.
- American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
- Visible muscle contraction response to NMES wrist extensors, bilaterally.
You likely can't join if
- Unhealed fracture in upper or lower extremities.
- Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or...
- High resting blood pressure greater than 140/80 mmHg.
- Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
- Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test...
- Implanted pacemakers and/or implanted defibrillator devices.
See the full eligibility criteria
- A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
- Participants must have a companion that will be able to help him/her throughout the study.
- Greater than 1-year post SCI, neurologic level of C8 or above.
- American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
- Visible muscle contraction response to NMES wrist extensors, bilaterally.
- Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers...
- Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
- Unhealed fracture in upper or lower extremities.
- Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
- High resting blood pressure greater than 140/80 mmHg.
- Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
- Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
- Implanted pacemakers and/or implanted defibrillator devices.
- Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant...
- Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
- Other exclusion criteria at the discretion of the medical team may include:
- Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
- Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
- Unresolved deep vein thrombosis.
- Psychiatric or cognitive impairments that preclude adherence to the intervention.
- Known cardiac pathology that precludes safe participation.
- Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
- Presence of pressure sores stage three or greater.
- Presence of a symptomatic urinary tract infection.
- Severe spasticity as assessed by the Modified Ashworth Scale.
- Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.