An observational study in Chronic Pain, Spasticity as Sequela of Stroke and Upper Motor Neuron Lesion, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Johns Hopkins University · Observational
Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma.
There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management.
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A subject who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in the study. A subject is considered enrolled when the subject signs the subject informed consent form.
Exclusion Criteria:
Patients identified with post-stroke pain due to spasticity. Patients will be evaluated for spinal cord stimulation trial. The trial will be for 7 days.
Device: Spinal Cord Stimulation- Closed loop
This is a percutaneously placed epidural electrode that is connected to a battery-powered impulse generator for power. The electrical delivery is monitored in real-time with the measurement of evoked compound action potentials and adjusted to provide titration of therapeutic stimulation delivery.
Pain as assessed by Visual Analog Score
Visual Analog Scores, pain score with possible range from zero (no pain) to ten (worst imaginable pain)
Time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)
Spasticity Reduction as assessed by the Modified Ashworth's Score
Modified Ashworth's Scores range from 0-4. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome
Time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)
Short Form 36 Health Survey (SF-36) score
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability
Time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)
Medication Use
Dose and frequency of medication use for current symptoms
Time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)
Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Effects on health-related quality of life that comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The survey is scored in two separate sections. The first section is measured by a minimum score of 5 and a maximum score of 25. Higher score greater level of problems. The second section measures self report health status on a 0 to 100. Higher score best health.
Time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)
Spinal cord neurophysiological wave morphology
Assessed using data downloaded from the implanted closed-loop SCS system. Will measure and report on the various morphologies of the Evoked Compound Action Potentials (ECAPs).
Time frame: day 1 (post-procedure), continuous data capture until day 7 (or until trial lead removal), day 14 (7 days post removal)
Spinal cord neurophysiological Current (mA/mV)
Assessed using data downloaded from the implanted closed-loop SCS system. Will measure and report on the current (mA/mV) of the Evoked Compound Action Potentials (ECAPs).
Time frame: day 1 (post-procedure), continuous data capture until day 7 (or until trial lead removal), day 14 (7 days post removal)
Spinal Cord Neurophysiological Characteristic- Conduction Velocity (m/s)
Assessed using data downloaded from the implanted closed-loop SCS system. Will measure and report on the conduction velocity (m/s) of the Evoked Compound Action Potentials (ECAPs).
Time frame: day 1 (post-procedure), continuous data capture until day 7 (or until trial lead removal), day 14 (7 days post removal)
Plan to share: No
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