Overview
Texas Biomedical Device Center at UT Dallas has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, an early feasibility study and an independent, double-blind, placebo-controlled study in chronic stroke participants indicate that VNS is safe in participants with upper limb deficits, and yields a clinically-significant three-fold increase in neural connections during rehabilitation exercises. Given the track record of safety and potential for VNS to enhance recovery of upper limb motor function in spinal cord injured individuals, the purpose of this double blind randomized placebo controlled optional open-label extension study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with SCI. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial. Participants may undergo additional sessions of training with VNS.
Eligibility
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the
duration of the study
- Adult, aged 18-64
- In good general health as evidenced by medical history and diagnosed with first time
cervical spinal cord injury resulting in an ASIA grade B, C, or D, and level 1 or
better motor function as described by the International Standards for Neurological
Classification of Spinal Cord Injury (ISNCSCI).
- SCI caused by trauma that occurred ≥ 12 months prior to enrollment
- Meets all clinical criteria for the surgical VNS implantation as determined by the PI,
surgeon, and anesthesiologist
- Must demonstrate some residual upper limb and hand movement in either arm
- Appropriate candidate for VNS implantation
- Willing and able to comply with the study protocol
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation
in this study:
- Spinal cord injuries by sharp objects, firearms, and non-traumatic or congenital
causes, even if at different levels of the spinal cord
- Any evidence of recurrent laryngeal nerve injury (Evident during required laryngoscopy
for all participants with Prior right-sided anterior cervical surgery- done prior to
randomization)
- Excessive scar tissue marking implantation unsafe (evident at surgery)
- Concomitant clinically significant brain injuries
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Participant receiving any therapy (medication or otherwise) that would interfere with
VNS
- Pregnancy or lactation
- Clinical complications that hinder or contraindicate the surgical procedure
- Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere
with study participation, as assessed by medical evaluation
- Abusive use of alcohol and/or illegal substances use
- Participation in other interventional clinical trial
- Participants with known immunodeficiency including participants who are receiving or
have received chronic corticosteroids, immunosuppressants, immunostimulating agents or
radiation therapy within 6 months
- Significant comorbidities or conditions associated with high risk for surgical or
anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac
disease, poorly controlled diabetes, immunosuppression, etc.).
- Active neoplastic disease.
- Participants with significant local circulatory problems, (e.g. thrombophlebitis and
lymphedema).
- Participants with any medical condition or other circumstances that might interfere
with their ability to return for follow-up visits in the judgment of the Investigator,
including systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency
that would render the participant unable to perform appropriate postoperative
rehabilitation.
- Any condition which, in the judgment of the Investigator, would preclude adequate
evaluation of device's safety and performance.
- Aphasia and other cognitive deficits that make understanding the potential risks and
benefits of the study impossible for participant. Inability to personally provide
informed consent.
- A recent history of syncope
- A recent history of dysphagia
- Currently require, or are likely to require diathermy
- Significant respiratory issues that would interfere with participation
- Non-English speaking
- Patients who are acutely suicidal and/or have been admitted for a suicide attempt
- Incarceration or legal detention