BridgeMD
New treatment option for Spinal Cord Injury
Official title Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
ClinicalTrials.gov ID: NCT05157282
What this study is testing
- What it's testing
- In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- for SCI:
- Male and female Veterans between 18-70 years
- Chronic SCI (1 year of injury)
- Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI [preliminary data (Benavides et al., 2020) and...
- Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
You likely can't join if
- Exclusion criteria for SCI and control people:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke
- Pacemaker
See the full eligibility criteria
- for SCI:
- Male and female Veterans between 18-70 years
- Chronic SCI (1 year of injury)
- Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI [preliminary data (Benavides et al., 2020) and analysis of MRIs in \~100 participants with cervical SCI confirm that...
- Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
- Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)...
- Able to produce a visible power grip with one hand
- Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP
- This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests for controls:
- Males and females (18-70 years)
- Right-handed
- Able to complete grasping
- Exclusion criteria for SCI and control people:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke
- Pacemaker
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
- Pregnant females
- Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Hines, Illinois, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Hines, Illinois, 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.