The role of pharmacological agents in restoring neuronal excitability after chronic SCI

Background

SCI leads to complex imbalances in central nervous system (CNS) circuits, resulting in a mix of
underactive circuits that drive voluntary movement, overactive circuits that drive uncontrolled
movement (spasticity), and impaired feedback responses. These imbalances act as barriers to functional recovery after SCI. Thus, drugs aiming to restore a normal balance of excitability within the damaged CNS are potential key therapies in SCI rehabilitation. 

We are testing magnetic brain and electrical spinal cord stimulation, along with muscle strength and
task performance during an activity, to better understand how the single-dose drugs influence nerve circuits for improving hand function. To stimulate the brain, we use transcranial magnetic stimulation (TMS). To stimulate the spinal cord, we use “low frequency stimulation”. All of these methods are non-invasive.

Note: This is a research study testing for temporary changes in nerve transmission and hand function.
There is no expectation of long-term benefit from this study. Any temporary changes seen in this study will be implemented in future studies attempting to prolong that effect.
Eligibility Criteria (summary)
  • Age 18-65 yo with chronic cervical SCI, occurred greater than 12 months ago
  • No history of severe traumatic brain injury (TBI), stroke, multiple sclerosis, Parkinson’s disease, or epilepsy
  • Other eligibility criteria will be screened in person to make sure it is safe for you to participate
  • Note: For your own safety, you will be required to give a small sample of blood once, during the
    screening process, to ensure that your kidney and liver are functioning normally prior to administering
    any study drug(s).
Procedures

7 visits lasting up to 4 hours each.

If you are an SCI participant, the first visit will be a screening visit to determine your eligibility.

What should you know
  • Electrical and magnetic stimulation can feel like a ‘shock’ that is temporarily uncomfortable at
    higher pulse strength
  • The main risk of magnetic brain stimulation is seizure. BUT:
    • Seizures are riskier when pulses are given faster than once per second – in this study, pulses are never given more than once every 5 or 10 seconds
    • The exclusion criteria are designed to prevent anyone at risk of seizure from
      participating.
    • When performed according to these recommendations, the risk of seizure is less than 1 in 1,000.
  • If you are uncomfortable at any time for any reason, we can stop the procedures. There is no
    obligation!!

Investigator
Lynda M. Murray, PhD

Study ID
PHARMA 1

Contact
Sig Sigafose or Francisco Castano

Clinicaltrials.gov Identifier
NCT05708274

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