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New treatment option for Spinal Cord Injuries
Official title Combination Therapy to Improve SCI Recovery.
ClinicalTrials.gov ID: NCT05563103
What this study is testing
- What it's testing
- The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.
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
- 18 to 70 years of age
- medically stable with medical clearance from study physician to participate
- SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level
- non-progressive etiology of spinal injury
- American Spinal Injury Association (ASIA) scores of C-D at initial screen
You likely can't join if
- severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract)...
- \< 24 on Mini-Mental Exam
- severe recurrent autonomic dysreflexia
- history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure \> 150 mmHg)
- pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
- botulinum toxin injections in lower extremity muscles within the prior three months
See the full eligibility criteria
- 18 to 70 years of age
- medically stable with medical clearance from study physician to participate
- SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level
- non-progressive etiology of spinal injury
- American Spinal Injury Association (ASIA) scores of C-D at initial screen
- ambulatory (able to complete the 10-meter walk test without support from another person)
- chronic injury (define as \> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery
- severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe...
- \< 24 on Mini-Mental Exam
- severe recurrent autonomic dysreflexia
- history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure \> 150 mmHg)
- pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
- botulinum toxin injections in lower extremity muscles within the prior three months
- history of tendon or nerve transfer surgery in the lower extremity
- untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study.
- active implanted devices (e.g., intrathecal baclofen pump)
- receiving concurrent electrical stimulation
- motor threshold evoked by transcutaneous spinal stimulation \>200 mA
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Cambridge, Massachusetts, 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 Chicago, Illinois, United States; Cambridge, Massachusetts, 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.