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

NCT04512690 | Completed DMC FDA Device

• 2 other identifiers: STUDY19090210UG3NS123135
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Adverse Events

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

  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

  7, 14, 21, 29 days

Secondary Outcomes (14)

• Motor Impairment

  15, 29 days

• Dexterity / Function: Action Research Arm Test

  7, 29 days

• Single Joint Force

  7, 14, 21, 29 days

• Joint Velocity

  7, 14, 21, 29 days

• Movement Smoothness

  7, 14, 21, 29 days

Study Arms (1)

Epidural electrical stimulation of the cervical spinal cord

EXPERIMENTAL

Individuals with prior subcortical stroke and hemiparesis of the upper extremity.

Device: Epidural electrical stimulation (EES) of the cervical spinal cord

Interventions

Epidural electrical stimulation (EES) of the cervical spinal cord DEVICE

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.

Epidural electrical stimulation of the cervical spinal cord

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee Fisher, PhD: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• 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.

  PMID: 27830790 BACKGROUND

• 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.

  PMID: 31257411 BACKGROUND

• 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.

  PMID: 24713270 BACKGROUND

• 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.

  PMID: 24305828 BACKGROUND

• 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.

  PMID: 27198185 BACKGROUND

• 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.

  PMID: 30440659 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Vascular Diseases

Study Officials

• Lee Fisher, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, non-randomized, open-label, descriptive, experimental

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 13, 2020
• Study Start: March 24, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)