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StrokeNCT04512690

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

A study testing Epidural electrical stimulation (EES) of the cervical spinal cord in people with Stroke and Brain Diseases, run by Lee Fisher, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 70 years
What is being tested?
Epidural electrical stimulation (EES) of the cervical spinal cord
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
24 Mar 2021to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
  • Participants must be between the ages of 21 and 70 years old.
  • Scores higher than 7 and lower than 50 on the Fugl-Meyer scale

Who cannot join

  • 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.
  • Pregnancy or breast feeding.
  • Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study.
  • Presence of any implanted medical devices.
  • Severe claustrophobia.
  • Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities
  • 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.
  • Evaluation to sign consent form score <12.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Being tested
Epidural electrical stimulation (EES) of the cervical spinal cord
Medical subject headings
Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural electrical stimulation (EES) of the cervical spinal cordDevice

    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.

Study groups in NCT04512690
Study groupRoleWhat they receive
Epidural electrical stimulation of the cervical spinal cordExperimentalIndividuals with prior subcortical stroke and hemiparesis of the upper extremity.
Receives: Device: Epidural electrical stimulation (EES) of the cervical spinal cord

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Serious Adverse Events

    Study is considered successful if no serious adverse events related to the use of electrical stimulation are reported

    Measured: 29 days

  2. 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

    Measured: 7, 14, 21, 29 days

Secondary outcomes (11)
  1. 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.

    Measured: Change from Baseline to 29 Day

  2. 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.

    Measured: Change from Baseline to 29 Days

  3. 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.

    Measured: 7, 14, 21, 29 days

  4. 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.

    Measured: 7, 14, 21, 29 days

  5. 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.

    Measured: 7, 14, 21, 29 days

  6. 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.

    Measured: 7, 14, 21, 29 days

  7. 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.

    Measured: 29 days

  8. 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.

    Measured: 29 days

  9. 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.

    Measured: 29 days

  10. 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

    Measured: 29 days

  11. 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.

    Measured: 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2020
  2. Study start24 Mar 2021
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, non-randomized, open-label, descriptive, experimental
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04512690
Sponsor's protocol ID
STUDY19090210
Other IDs
UG3NS123135
Status last verified
Aug 2025
First submitted
24 Jul 2020
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Data may be shared with other researchers for the purpose of data analysis and collaboration.

Publications

  • Capogrosso M, Milekovic T, Borton D, Wagner F, Moraud EM, Mignardot JB, Buse N, Gandar J, Barraud Q, Xing D, Rey E, Duis S, Jianzhong Y, Ko WK, Li Q, Detemple P, Denison T, Micera S, Bezard E, Bloch J, Courtine G. A brain-spine interface alleviating gait deficits after spinal cord injury in primates. Nature. 2016 Nov 10;539(7628):284-288. doi: 10.1038/nature20118.

    PubMed 27830790
  • Coscia M, Wessel MJ, Chaudary U, Millan JDR, Micera S, Guggisberg A, Vuadens P, Donoghue J, Birbaumer N, Hummel FC. Neurotechnology-aided interventions for upper limb motor rehabilitation in severe chronic stroke. Brain. 2019 Aug 1;142(8):2182-2197. doi: 10.1093/brain/awz181.

    PubMed 31257411
  • Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8.

    PubMed 24713270
  • Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.

    PubMed 24305828
  • Lu DC, Edgerton VR, Modaber M, AuYong N, Morikawa E, Zdunowski S, Sarino ME, Sarrafzadeh M, Nuwer MR, Roy RR, Gerasimenko Y. Engaging Cervical Spinal Cord Networks to Reenable Volitional Control of Hand Function in Tetraplegic Patients. Neurorehabil Neural Repair. 2016 Nov;30(10):951-962. doi: 10.1177/1545968316644344. Epub 2016 May 18.

    PubMed 27198185
  • Barra B, Roux C, Kaeser M, Schiavone G, Lacour SP, Bloch J, Courtine G, Rouiller EM, Schmidlin E, Capogrosso M. Selective Recruitment of Arm Motoneurons in Nonhuman Primates Using Epidural Electrical Stimulation of the Cervical Spinal Cord. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1424-1427. doi: 10.1109/EMBC.2018.8512554.

    PubMed 30440659
  • Borda L, Verma N, Sorensen E, Carranza E, de Freitas R, Ensel S, Boos A, Gerszten PC, Fields DP, Wittenberg GF, Fisher LE, Pirondini E, Capogrosso M, Weber DJ. Spinal cord stimulation modulates post-synaptic inhibition to improve arm neuromotor control after chronic stroke. Cell Rep Med. 2026 Aug 18;7(8):102925. doi: 10.1016/j.xcrm.2026.102925. Epub 2026 Jul 17.

    PubMed 42468533
  • de Freitas RM, Bhatia S, Sorensen E, Verma N, Carranza E, Ensel S, Borda L, Boos A, Goldsmith J, Fisher LE, Fields DP, Powell MP, Gordon S, Balzer J, Friedlander RM, Wittenberg GF, Gerszten PC, Krakauer JW, Pirondini E, Weber DJ, Capogrosso M. Spinal cord stimulation for upper limb motor function in people with chronic post-stroke hemiparesis: a feasibility trial. Nat Med. 2026 Jul;32(7):2579-2590. doi: 10.1038/s41591-026-04435-1. Epub 2026 Jun 4.

    PubMed 42243548

Questions about this trial

What is this clinical trial studying?

A study testing Epidural electrical stimulation (EES) of the cervical spinal cord in people with Stroke and Brain Diseases, run by Lee Fisher, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Serious Adverse Events (time frame: 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04512690, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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