Clinical trial NCT04512690: Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke
Official title: Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, open-label, descriptive, experimental
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 29 days
measure: Discomfort and Pain
timeFrame: 7, 14, 21, 29 days
Secondary outcomes:
measure: Motor Impairment
timeFrame: 15, 29 days
measure: Dexterity / Function: Action Research Arm Test
timeFrame: 7, 29 days
measure: Single Joint Force
timeFrame: 7, 14, 21, 29 days
measure: Joint Velocity
timeFrame: 7, 14, 21, 29 days
measure: Movement Smoothness
timeFrame: 7, 14, 21, 29 days
measure: Time to Target
timeFrame: 7, 14, 21, 29 days
measure: Sensory motor integration: success-rate
timeFrame: 7, 14, 21, 29 days
measure: Sensory motor integration: displacement error
timeFrame: 7, 14, 21, 29 days
measure: Spasticity
timeFrame: 7, 15, 21, 29 days
measure: Sensorimotor Network Function
timeFrame: 29 days
measure: Sensorimotor Network Structure Integrity
timeFrame: 29 days
measure: Cortico-spinal Tract Integrity
timeFrame: 29 days
measure: Spinal Circuit Excitability
timeFrame: 7, days
measure: Motoneuron Firing Rates
timeFrame: 7, 14, 21, 29 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Lee Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.