An interventional study of Epidural electrical stimulation (EES) of the cervical spinal cord in Stroke, Brain Diseases and Central Nervous System Diseases, sponsored by Lee Fisher, PhD. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Lee Fisher, PhD · Not applicable, Interventional, and Basic science
The goal of this study is to verify whether electrical stimulation of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neurorehabilitation programs to restore upper limb motor function in people with subcortical strokes, thereby increasing independence and quality of life.
Specifically, researchers will 1) quantify the motor potentials in arm and hand muscles generated by single pulses of electrical stimulation of the spinal cord using FDA-cleared devices 2) characterize optimal stimulation parameter ranges to maximize induced arm and hand movement, 3) measure neural changes that could be induced by the system, 4) characterize potential clinical effects by assessing patient mobility, spasticity, and neurophysiology with standard clinical tests and simple motor tasks.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 8 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
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Exclusion Criteria:
Individuals with prior subcortical stroke and hemiparesis of the upper extremity.
Device: Epidural electrical stimulation (EES) of the cervical spinal cord
All participants enrolled in this group will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days.
Number of Serious Adverse Events
Study is considered successful if no serious adverse events related to the use of electrical stimulation are reported
Time frame: 29 days
Discomfort and Pain
We will assess the relative level of discomfort and/or pain that is associated to the delivery of stimulation to the spinal cord. After each stimulation trains patients will be asked to report their perceived discomfort level using a 10 value subjective scale. Low values will be assigned to low discomfort, and high values to high discomfort.The study is considered successful if 70% of recruited subjects does not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the muscles of the arm and hand. This is the total number across all assessments dates
Time frame: 7, 14, 21, 29 days
Motor Impairment
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 (most severe) to 66 points (less severe). Minimal Detectable Change (MDC) is 5.2 points. The MCID (Minimally Clinically Important Difference) is 4.25 to 7.25.
Time frame: Change from Baseline to 29 Day
Dexterity / Function: Action Research Arm Test
The investigators will use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. Performances will be compared with SCS-on against SCS-off. The investigators will consider as a minimally acceptable improvement an increase in the affected arm total score of \>4 points. Comparison will be done per patient between Stim-on, Stim-off. Maximum score on the test is 57 points, minimum score is zero points, with a higher value indicating better dexterity/function.
Time frame: Change from Baseline to 29 Days
Single Joint Force
Isometric torque: measure the isometric torque produced by the subject at the shoulder, elbow and wrist joints. Comparison of SCS-on with SCS-off performance. Success Criteria: ≥20% increased torque production over SCS-off baseline as measured during single-joint isometric torque.
Time frame: 7, 14, 21, 29 days
Joint Velocity
The investigators will use the KINARM robot to quantify joint velocity. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify joint velocity in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
Time frame: 7, 14, 21, 29 days
Movement Smoothness
The investigators will use the KINARM robot to quantify movement smoothness. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify movement smoothness in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
Time frame: 7, 14, 21, 29 days
Time to Target
The investigators will use the KINARM robot to quantify time to target. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify time to target in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
Time frame: 7, 14, 21, 29 days
Sensory Motor Integration: Success-rate
The investigators will use the KINARM robot to quantify functional sensory acuity and sensory-motor integration. The investigators will measure 2D kinematics of the arm during different exercises where subjects will reach to defined targets with and without visual feedback. These tasks are designed to assess proprioception acuity and sensory-motor integration. Success-rate will be quantified offline. Comparison will be done per patient between Stim-on and Stim-off at different timepoints. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on sensorimotor integration processes.
Time frame: 29 days
Sensory Integration: Displacement Error. Number of Participants That Improved Position Error in Passive Position Matching Task
The investigators will use the KINARM robot to quantify functional sensory acuity and sensory-motor integration. The investigators will measure 2D kinematics of the arm during different exercises where subjects will reach to defined targets with and without visual feedback. These tasks are designed to assess proprioception acuity and sensory-motor integration. Displacement error from true target location will be quantified offline. Comparison will be done per patient between Stim-on and Stim-off at different timepoints. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on sensorimotor integration processes.
Time frame: 29 days
Spasticity
The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow and wrist joint. The investigators will consider as a minimally acceptable improvement a decrease of MAS \>1, if available for the specific joint. Comparison will be done per patient between Stim-on and Stim-off and pre-study baselines. Maximum score on the MAS is 4, minimum score is 0, with a lower number indicating less spasticity. Measure is the MAS score at day 29 minus the score at baseline.
Time frame: 29 days
Sensorimotor Network Structure Integrity
The investigators will perform High-definition Diffusion Weighted Imaging to quantify Fractional Anisotropy as a measurement of axon integrity in the brain and spinal cord pre and post study. We assessed the residual anatomical integrity of CST by using fractional anisotropy (FA) of diffusion-weighted MR images. Fractional anisotropy (FA) is a unitless scalar (range: 0-1) derived from diffusion tensor imaging (DTI) that reflects the degree of directional water diffusion within white matter. It is calculated as a normalized ratio of diffusion along principal versus non-principal directions. Higher FA values indicate greater microstructural organization and integrity of the corticospinal tract (CST), whereas lower values suggest reduced integrity
Time frame: 29 days
Cortico-spinal Tract Integrity
The investigators will measure muscle evoked potential consequent to Transcranial Magnetic Stimulation of the cortico-spinal tract to assess integrity of the cortico-spinal tract. They will also explore SCS responses when conditioned by a TMS pulse and vice-versa.
Time frame: 29 days
We enrolled a total of 8 participants (21-70 years old) with ischemic or hemorrhagic stroke resulting in upper-extremity hemiparesis more than 6 months prior to enrollment.
| Milestone | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
Study is considered successful if no serious adverse events related to the use of electrical stimulation are reported
| Serious Adverse Events | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Number of Serious Adverse Events | 0 |
We will assess the relative level of discomfort and/or pain that is associated to the delivery of stimulation to the spinal cord. After each stimulation trains patients will be asked to report their perceived discomfort level using a 10 value subjective scale. Low values will be assigned to low discomfort, and high values to high discomfort.The study is considered successful if 70% of recruited subjects does not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the muscles of the arm and hand. This is the total number across all assessments dates
| Participants | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Discomfort and Pain | 0 |
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 (most severe) to 66 points (less severe). Minimal Detectable Change (MDC) is 5.2 points. The MCID (Minimally Clinically Important Difference) is 4.25 to 7.25.
| points | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Motor Impairment | 6.57 (2 to 15) |
The investigators will use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. Performances will be compared with SCS-on against SCS-off. The investigators will consider as a minimally acceptable improvement an increase in the affected arm total score of \>4 points. Comparison will be done per patient between Stim-on, Stim-off. Maximum score on the test is 57 points, minimum score is zero points, with a higher value indicating better dexterity/function.
| points | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Dexterity / Function: Action Research Arm Test | 4.83 ± 6.55 |
Isometric torque: measure the isometric torque produced by the subject at the shoulder, elbow and wrist joints. Comparison of SCS-on with SCS-off performance. Success Criteria: ≥20% increased torque production over SCS-off baseline as measured during single-joint isometric torque.
| percentage of MVC increase | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Single Joint Force | 31.74 (12.06 to 56.94) |
The investigators will use the KINARM robot to quantify joint velocity. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify joint velocity in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
| difference in movement time (s) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| reach phase | -0.41 ± 0.62 |
| pull phase | -0.67 ± 1.10 |
The investigators will use the KINARM robot to quantify movement smoothness. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify movement smoothness in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
| a.u. | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| reach phase | 9.6 (3.8 to 14.6) |
| pull phase | 10.2 (3.2 to 16.8) |
The investigators will use the KINARM robot to quantify time to target. The investigators will measure 2D kinematics of the arm during several different horizontal reaching tasks. The investigators will also quantify time to target in 3D while subjects perform reach and grasp tasks unsupported. Subjects will be tasked to reach to targets or objects and manipulate objects while 3D videos of their arm and hand movements are recorded. Arm and hand kinematics will then be analyzed offline in parallel to EMG analysis of arm and hand muscles. Comparison will be done per patient between Stim-on and Stim-off at different time-points. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on arm kinematics.
| difference in movement time (s) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| reach phase | -0.41 ± 0.62 |
| pull phase | -0.67 ± 1.10 |
The investigators will use the KINARM robot to quantify functional sensory acuity and sensory-motor integration. The investigators will measure 2D kinematics of the arm during different exercises where subjects will reach to defined targets with and without visual feedback. These tasks are designed to assess proprioception acuity and sensory-motor integration. Success-rate will be quantified offline. Comparison will be done per patient between Stim-on and Stim-off at different timepoints. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on sensorimotor integration processes.
| Participants | Sensory Testing |
|---|---|
| Sensory Motor Integration: Success-rate | 5 |
The investigators will use the KINARM robot to quantify functional sensory acuity and sensory-motor integration. The investigators will measure 2D kinematics of the arm during different exercises where subjects will reach to defined targets with and without visual feedback. These tasks are designed to assess proprioception acuity and sensory-motor integration. Displacement error from true target location will be quantified offline. Comparison will be done per patient between Stim-on and Stim-off at different timepoints. Given the scientific nature of this task no minimal acceptable improvement is defined and data will be used to understand effects of SCS on sensorimotor integration processes.
| Participants | Sensory Testing |
|---|---|
| Sensory Integration: Displacement Error. Number of Participants That Improved Position Error in Passive Position Matching Task | 4 |
The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow and wrist joint. The investigators will consider as a minimally acceptable improvement a decrease of MAS \>1, if available for the specific joint. Comparison will be done per patient between Stim-on and Stim-off and pre-study baselines. Maximum score on the MAS is 4, minimum score is 0, with a lower number indicating less spasticity. Measure is the MAS score at day 29 minus the score at baseline.
| MAS points | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Spasticity | -3.5 ± 3.3 |
The investigators will perform High-definition Diffusion Weighted Imaging to quantify Fractional Anisotropy as a measurement of axon integrity in the brain and spinal cord pre and post study. We assessed the residual anatomical integrity of CST by using fractional anisotropy (FA) of diffusion-weighted MR images. Fractional anisotropy (FA) is a unitless scalar (range: 0-1) derived from diffusion tensor imaging (DTI) that reflects the degree of directional water diffusion within white matter. It is calculated as a normalized ratio of diffusion along principal versus non-principal directions. Higher FA values indicate greater microstructural organization and integrity of the corticospinal tract (CST), whereas lower values suggest reduced integrity
| Unitless | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Sensorimotor Network Structure Integrity | 0.15 ± 0.06 |
The investigators will measure muscle evoked potential consequent to Transcranial Magnetic Stimulation of the cortico-spinal tract to assess integrity of the cortico-spinal tract. They will also explore SCS responses when conditioned by a TMS pulse and vice-versa.
| Participants | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| MEP-positive | 4 |
| MEP-negative | 3 |
Collected over from enrollment until end of follow-up assessments (1 month after participants were explanted). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epidural Electrical Stimulation of the Cervical Spinal Cord | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| Event | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Pain at the site where the leads exit the bodySkin and subcutaneous tissue disorders | 1/7 |
| Difficulty in breathing when SCS targeted C3 and C4 spinal levelsRespiratory, thoracic and mediastinal disorders | 1/7 |
| Lead migrationSurgical and medical procedures | 1/7 |
| Age, Categorical(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Female | 4 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| MEP status(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| MEP-positive | 4 |
| MEP-negative | 3 |
| SSEP status(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| SSEP-positive | 5 |
| SSEP-negative | 2 |
| Hand opening(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Yes | 3 |
| No | 4 |
| Stroke Type(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Ischemic | 4 |
| Hemorrhagic | 3 |
| Stroke Lesioned Hemisphere(Participants) | Epidural Electrical Stimulation of the Cervical Spinal Cord |
|---|---|
| Right | 5 |
| Left | 2 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data 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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Lee Fisher, PhD