Trial · NCT07890558
Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation
NCT07890558, Not applicable, Recruiting, Kessler Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation. Trials, record NCT07890558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation
- NCT number
- NCT07890558
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 8 participants, estimated
- Lead sponsor
- Kessler Foundation
- Conditions
- SCI - Spinal Cord Injury, Spasticity
- Interventions
- Epidural implant stimulation device
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | Three common triggers of spasticity for each person will be identified, such as quick stretch of the ankle, flexion/extension of the hip, and rapid position changes. Each trigger will be implemented consecutively three times while recording EMG from the hip, knee, and ankle muscles bilaterally. The EMG data will be full wave rectified and filtered using a 4th order bandpass Butterworth filter (40 Hz - 500 Hz) representing the relative number and frequencies of the motor units recruited per burst. Integrated EMG will assess the total EMG activity generated in response to the spasticity trigger for each muscle for each attempt. Muscles: (SOL), medial gastrocnemius (MG), tibialis anterior (TA), medial hamstrings (MH), quadriceps (VL and RF), adductor (AD) and/or other related muscles. |
| Secondary | The Penn Spasm Scale | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | The Penn Spasm Scale is a 2-part self-report noting both the severity and frequency of spasms. Frequency is a 0-4 scale with 0 being no spasms and 4 being more than 10 spasms per hour. Severity is a 1-3 scale with 1 being mild, 2 is moderate and 3 is severe. Severity is not measured if frequency is 0. |
| Secondary | Modified Ashworth Score | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | Modified Ashworth Score assesses on a scale of 0 to 4 the resistance of a relaxed, single joint as it is moved throughout its full available range of motion. Participants will be instructed to relax and to allow the examiner to perform the test movement. A zero indicates the area moves freely with no resistance, while a 4 indicates the area is rigid and cannot move. |
| Secondary | Frequency of Side Effects | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | Participants will report subjective experiences of side effects including fatigue, drowsiness, dizziness, weakness, confusion, headache, nausea, and sexual dysfunction. STIMX PICS algorithms will be recorded using temporaneous recording of each effect and its duration at the time of each experience. STIMX PICS recordings (subjective frequency of side effects) will occur for 24 hours twice prior to implantation and weekly after surgery throughout the 3 months of intervention. |
| Secondary | Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | Hip and knee extension and flexion and ankle dorsi and plantar flexion will be attempted consecutively three times in response to a 3 tone while recording EMG from the hip, knee, and ankle muscles bilaterally. The EMG data will be full wave rectified and filtered using a 4th order bandpass Butterworth filter (40 Hz - 500 Hz) representing the relative number and frequencies of the motor units recruited per burst. |
| Secondary | NeuroRecovery Scale (NRS) for Lower Body and Trunk | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | The NRS is a valid, reliable, and responsive evaluation tool for measuring functional recovery in persons with SCI based on tasks that test pre-injury functional capability. It uses a 12-item scale focusing on lower extremity and trunk function including sit up, sit, reverse sit up, trunk extension in sitting, and stand with a maximum score of 72 points, which represents full recovery of pre-injury function, and minimum score of 0 points, which represents no change in functional recovery. |
| Secondary | The AIS Impairment Scale | Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. | The ASIA Impairment Scale (AIS) is a classification in SCI that describes the level and severity of the injury, based upon the motor and sensory examination as described in the International Standards of Neurological Classification for SCI (ISNCSCI). This scale ranges from A-E, with A being complete (no motor or sensory function) and E being normal (no sensory or motor impairment) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07890558
GET https://conductscience.org/api/trials/v1/NCT07890558/registered