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Recruiting

NCT Number: NCT05705453

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 22 years of age or older
  • Able to undergo the informed consent process
  • Stable spinal cord injury
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
  • No ventilator dependency within the last year
  • American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
  • Medically stable in the judgment of the Principal investigator
  • Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
  • Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
  • Spinal imaging of the stimulator system

Exclusion criteria

  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
  • Use of botulinum toxin (Botox) injections in the previous six months
  • Clinically significant mental illness in the judgment of the principal investigator
  • Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
  • Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
  • Current Pregnancy
  • Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Treatment and study plan

Epidural Spinal Cord Stimulation

Device

Stimulation of the spinal cord from the epidural space.

Primary outcomes

  1. Change in Volitional electromyography (EMG) power

    Time frame: 10 years

    The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation

Secondary outcomes

  1. Prediction of power preferences

    Time frame: 10 years

    Prediction of power of preference models built based on evaluations of stimulation settings.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

612-873-9113

Study Coordinator

CONTACT

[email protected]

612-873-9113

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: LTO

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
Jan 30, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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