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Determining electrophysiological and functional interactions between oral baclofen and spinal neuromodulation in humans with spinal cord injury.

Award Number: R56NS146584
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Determining electrophysiological and functional interactions between oral baclofen and spinal neuromodulation in humans with spinal cord injury. - PROJECT SUMMARY / ABSTRACT Over 250,000 United States citizens are living with paralysis from traumatic spinal cord injury (SCI) and approximately 17,500 new individuals are injured each year. Considering there is no known cure to heal the spinal cord after injury, individuals who survive the acute phase of SCI often endure lifelong impairments of motor control. In addition to paralysis, sub-lesional spinal sensorimotor networks (SSNs) commonly establish a state of hyperexcitability that can generate uncontrolled motor activity, termed spasticity. This can be painful, impair sleep and quality of life, and place individuals at danger from falls. Spastic activity is often treated clinically by suppressing SSN hyperexcitability via gamma-aminobutyric acid (GABA) agonist medications, such as baclofen. Baclofen reduces spasticity via synaptic inhibition of spinal reflex pathways, which are thought to be the primary targets for activation via spinal cord stimulation (SCS). SCS has recently demonstrated revolutionary recovery of motor function that had been thought permanently impaired by SCI and works by facilitating this same SSN activity. Unfortunately, recent clinical trials of SCS have excluded individuals who take baclofen to reduce their spasticity, which has created a major gap in knowledge of the impact baclofen has on stimulation-related SSN activity, as well as downstream sensorimotor function generated by SSNs during SCS. Considering SCS technologies on the cusp of widespread deployment into the clinical setting and over half of all individuals with SCI take baclofen, there is an urgent need to understand the extent to which the inhibitory effects of baclofen blunt the therapeutic potential of SCS. To address this gap in knowledge, we will conduct a clinical trial that is designed to characterize the inhibitory effects of baclofen on SCS-related motor activity and lower extremity function in humans with chronic paralysis due to traumatic SCI. This study will involve two cohorts totaling 30 participants. During 8 daily sessions, cohort 1 (15 participants) will receive transcutaneous stimulation applied to the skin surface over the lumbosacral spinal cord. Cohort 2 will receive stimulation via percutaneously implanted leads positioned to both stimulate and record lumbosacral SSN activity. For all participants, baclofen concentrations will be characterized using blood and cerebrospinal fluid samples collected regularly over 6 hours following repeated oral administration. At each collection timepoint, we will leverage protocols already established in our laboratory to capture skin surface electromyography (EMG) of lower extremity muscle contractions during SCS to determine the inhibitory effect of baclofen on spinal sensorimotor output generated by SCS. Completion of the proposed work will generate new knowledge of electrophysiological and functional impact of antispasmodic medications on SSN activity during SCS. As emerging technologies translate to clinical use, SCI care providers and patients will undoubtedly leverage this knowledge to understand the effects of combined administration of SCS and antispasmodic medication.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $550,273 )
2026	2026	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/16/2026	NEW	$550,273
														Subtotal = $550,273

Grand Total All Awards = $550,273

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Determining electrophysiological and functional interactions between oral baclofen and spinal neuromodulation in humans with spinal cord injury.

Award Number: R56NS146584

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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