Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke

August 5, 2025 updated by: Lee Fisher, PhD
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lee Fisher, PhD
  • Phone Number: 412-383-1329
  • Email: lef44@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more than 6 months prior to the time of enrollment. (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
  2. Participants must be between the ages of 21 and 70 years old.
  3. Scores higher than 7 and lower than 50 on the Fugl-Meyer scale

Exclusion Criteria:

  1. Serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities.
  2. Pregnancy or breast feeding.
  3. Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study.
  4. Presence of any implanted medical devices.
  5. Severe claustrophobia.
  6. Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities
  7. Results from the Brief Symptoms Inventory (BSI-18) and additional discussions with the Principal Investigator and a study physician that deem participant inappropriate for the study.
  8. Evaluation to sign consent form score <12.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epidural electrical stimulation of the cervical spinal cord
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 29 days
Study is considered successful if no serious adverse events related to the use of electrical stimulation are reported
29 days
Discomfort and Pain
Time Frame: 7, 14, 21, 29 days
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
7, 14, 21, 29 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motor Impairment
Time Frame: 15, 29 days
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 to 66 points. Minimal Detectable Change (MDC) is 5.2 points. The MCID (Minimally Clinically Important Difference) is 4.25 to 7.25.
15, 29 days
Dexterity / Function: Action Research Arm Test
Time Frame: 7, 29 days
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 and pre-study baselines. Maximum score on the test is 57 points, minimum score is zero points, with a higher value indicating better dexterity/function.
7, 29 days
Single Joint Force
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Joint Velocity
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Movement Smoothness
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Time to Target
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Sensory motor integration: success-rate
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Sensory motor integration: displacement error
Time Frame: 7, 14, 21, 29 days
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.
7, 14, 21, 29 days
Spasticity
Time Frame: 7, 15, 21, 29 days
The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow and wrist joint and compare values with SCS-on and SCS-off. 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.
7, 15, 21, 29 days
Sensorimotor Network Function
Time Frame: 29 days
The investigators will perform resting state and motor-task functional MRI of the brain and spinal cord to quantify neural network activation at rest and during the execution of simple motor tasks.
29 days
Sensorimotor Network Structure Integrity
Time Frame: 29 days
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.
29 days
Cortico-spinal Tract Integrity
Time Frame: 29 days
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.
29 days
Spinal Circuit Excitability
Time Frame: 7, days
The investigators will measure H-reflexes of arm muscles obtained during stimulation of the peripheral nerves to quantify excitability of spinal motoneurons to stimulation of primary sensory afferents pre and post-study. Expected Result: The main scientific hypothesis is that SCS will change sensori-to-motoneuron excitability that can be measured via H-reflex responses pre and post-implant.
7, days
Motoneuron Firing Rates
Time Frame: 7, 14, 21, 29 days
The investigators will use high-density EMGs on arm muscles to calculate firing rates of single spinal motoneuron discharge during isometric maximal voluntary contractions.
7, 14, 21, 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lee Fisher, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lee Fisher, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19090210
  • UG3NS123135 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data may be shared with other researchers for the purpose of data analysis and collaboration.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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