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

Lee Fisher, PhD

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04512690

UG3NS123135 (U.S. NIH Grant/Contract)

STUDY19090210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Epidural electrical stimulation of the cervical spinal cord

Experimental group

Description:

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

Treatment:

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