Epidural Stimulation After Neurologic Damage

Spinal Cord Injuries Clinical Trial

— E-STAND  

Official title:

Epidural Stimulation for Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026816
• Other study ID #: NEUROSURG-2017-25478
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Study Coordinator
• Phone: 612-873-9113
• Email: estand[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Description:

Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability.

In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 22 years of age or older

• Able to undergo the informed consent/assent process

• Stable, motor-complete paraplegia

• Discrete spinal cord injury between C6 and T10

• ASIA A or B Spinal Cord Injury Classification

• Medically stable in the judgement of the principal investigator

• Intact segmental reflexes below the lesion of injury

• Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation

• Willing to attend all scheduled appointments

Exclusion Criteria:

• Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)

• Inability to withhold antiplatelet/anticoagulation agents perioperatively

• Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.

• Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator

• Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator

• Clinically significant mental illness in the judgement of the principal investigator

• Botulinum toxin injections in the previous 6 months

• Volitional movements present during EMG testing in bilateral lower extremities

• Unhealed spinal fracture

• Presence of significant contracture

• Presence of pressure ulcers

• Recurrent urinary tract infection refractory to antibiotics

• Current Pregnancy

Related Conditions & MeSH terms

• Paraplegia
• Paraplegia, Complete
• Spinal Cord Injuries

Intervention

Device:
• Epidural Spinal Cord Stimulation
epidural spinal cord stimulator

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
University of Minnesota	Hennepin County Medical Center, Minneapolis, Hennepin Healthcare Research Institute, Minneapolis Veterans Affairs Medical Center, Minnesota Office of Higher Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Volitional Response Index Magnitude	Brain Motor Control Assessment Volitional Response Index Magnitude	Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Secondary	Spinal cord stimulation for cardiovascular function	Systolic blood pressure measured during epidural stimulation (continuous)	Over 12 months
Secondary	Cerebrovascular Assessment Change	Cerebral blood flow (CBF) during tilt table	Months: 3, 6, 9
Secondary	Change in Visual Neurocognitive Assessment	Stroop Test	Months: 3, 6, 9
Secondary	Spinal cord stimulation optimization	Probit preference response surface obtained by serial force binary choice	Over 12 months

External Links

•   Clinical Trial Website