An interventional study of Bipolar Neural Stimulation Electrode in Stroke and Able Bodied, sponsored by Peter C. Gerszten, MD. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Peter C. Gerszten, MD · Not applicable, Interventional, and Basic science
The goal of this study is to assess cervical (neck) reflexes by intra-operatively stimulating the neck nerve roots to evoke motor responses through their connections to spinal motoneurons. This data is critical to reveal changes to the spinal sensory modulating circuitry in neurological disorders like stroke.
Spinal afferents continuously convey sensory information on limb movements to the central nervous system which not only gives people conscious experience of movement, but also plays a major role in shaping motor output through monosynaptic afferent-motoneuronal connections. Stroke induces changes in the spinal circuitry modulating this sensory input, leading to sensorimotor deficits.
Specifically, the investigators will 1) activate the dorsal root fibers with single and double electrical stimulation pulses at various frequencies using FDA-cleared devices, 2) quantify the stimulation evoked motor potentials in arm and hand muscles recorded with intramuscular EMGs, 3) quantify stimulation evoked sensory potentials in the cortex with intra-op EEGs.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 15 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Peter C. Gerszten, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals undergoing cervical spinal surgery will receive direct electrical stimulation to the cervical dorsal spinal nerve roots.
Device: Bipolar Neural Stimulation Electrode
All individuals enrolled in this study will receive electrical stimulation to the dorsal cervical spinal nerves using the FDA-cleared bipolar stimulating electrode routinely used as standard-of-care to monitor neural function, during which muscle activities will be recorded through intramuscular electromyography (EMGs), and sensory evoked cortical local field potentials (SSEPs) will be acquired simultaneously to characterize properties of the spinal sensory pathways.
Spinal Circuit Excitability
The investigators will record intramuscular electromyogram (EMG) of the hand and arm muscles evoked by dorsal nerve root stimulation at various frequencies to quantify spinal circuit excitability through the H-reflex. A mean difference of 10% from the baseline (first pulse per frequency) muscle activation will be considered a meaningful change in excitability.
Time frame: 1 day
Sensory Transmission to the Brain
The investigators will use electroencephalograph (EEG) to record sensory stimulation evoked potentials (SSEP) from the brain during dorsal root stimulation at various frequencies to quantify sensory transmission efficiency. A mean difference of 10% from the baseline (first pulse per frequency) SSEP will be considered a meaningful change.
Time frame: 1 day
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 5 years from enrollment of the first participant.
Access criteria: Data must be directly requested from the PI and will be shared upon completion of the necessary data-sharing agreement to protect confidential patient information.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.