NCT03026816

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2017Jan 2028

First Submitted

Initial submission to the registry

January 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

9.4 years

First QC Date

January 1, 2017

Last Update Submit

April 2, 2026

Conditions

Spinal Cord InjuriesParaplegia, Complete

Keywords

epidural stimulationspinal cord stimulationautonomic dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Spinal cord stimulation for cardiovascular function

    Over 12 months

  • Cerebrovascular Assessment Change

    Months: 3, 6, 9

  • Change in Visual Neurocognitive Assessment

    Months: 3, 6, 9

  • Spinal cord stimulation optimization

    Over 12 months

Study Arms (1)

Epidural Spinal Cord Stimulation

EXPERIMENTAL

Epidural Spinal Cord Stimulation

Device: Epidural Spinal Cord Stimulation

Interventions

Epidural Spinal Cord StimulationDEVICE

epidural spinal cord stimulator

Epidural Spinal Cord Stimulation

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Related Publications (5)

  • Shackleton C, Samejima S, Miller T, Sachdeva R, Parr A, Samadani U, Netoff T, Hocaloski S, Elliott S, Walter M, Darrow D, Krassioukov A. Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury. Front Neurosci. 2023 Apr 5;17:1155796. doi: 10.3389/fnins.2023.1155796. eCollection 2023.

    PMID: 37179555DERIVED

  • Hoover C, Schuerger W, Balser D, McCracken P, Murray TA, Morse L, Parr A, Samadani U, Netoff TI, Darrow DP. Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. J Neurotrauma. 2024 May;41(9-10):1163-1171. doi: 10.1089/neu.2022.0322. Epub 2023 Mar 22.

    PMID: 36719784DERIVED

  • Hoglund BK, Zurn CA, Madden LR, Hoover C, Slopsema JP, Balser D, Parr A, Samadani U, Johnson MD, Netoff TI, Darrow DP. Mapping Spinal Cord Stimulation-Evoked Muscle Responses in Patients With Chronic Spinal Cord Injury. Neuromodulation. 2023 Oct;26(7):1371-1380. doi: 10.1016/j.neurom.2022.10.058. Epub 2022 Dec 12.

    PMID: 36517395DERIVED

  • Darrow DP, Balser DY, Freeman D, Pelrine E, Krassioukov A, Phillips A, Netoff T, Parr A, Samadani U. Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial. BMJ Open. 2022 Jul 18;12(7):e059126. doi: 10.1136/bmjopen-2021-059126.

    PMID: 35851008DERIVED

  • Pena Pino I, Hoover C, Venkatesh S, Ahmadi A, Sturtevant D, Patrick N, Freeman D, Parr A, Samadani U, Balser D, Krassioukov A, Phillips A, Netoff TI, Darrow D. Long-Term Spinal Cord Stimulation After Chronic Complete Spinal Cord Injury Enables Volitional Movement in the Absence of Stimulation. Front Syst Neurosci. 2020 Jun 30;14:35. doi: 10.3389/fnsys.2020.00035. eCollection 2020.

    PMID: 32714156DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegiaPrimary Dysautonomias

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutonomic Nervous System Diseases

Study Officials

  • David Darrow, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

612-873-9113estand@umn.edu

David Darrow, MD MPH

CONTACT

612-217-4290estand@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking is done during formal testing of BMCA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2017

First Posted

January 20, 2017

Study Start

August 7, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)