Epidural Stimulation in Chronic Spinal Cord Injury Patients

Last updated: March 13, 2023
Sponsor: University Hospital, Motol
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT05690074
EK-1302/21
  • Ages 18-60
  • All Genders

Study Summary

Investigators propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular, urinary and sexual function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment. In addition investigators suggest to prove on functional magnetic resonance imaging if there are some significant changes before and after the stimulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • non-progressive SCI with complete motor paralysis below T1; American Spinal InjuryAssociation Impairment Scale (AIS) A or B
  • 18 - 60 years of age;
  • longer than 2 years post injury;
  • stable medical condition
  • unable to voluntarily move all single joints of the legs;
  • spinal cort lesion between C7 and Th10

Exclusion

Exclusion Criteria:

  • ventilator dependent;
  • painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sorethat might interfere with training;
  • clinically significant depression or ongoing drug abuse;
  • cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
  • severe anemia (Hgb<8 g/dl) or hypovolemia; and HIV or AIDS related illness.

Study Design

Total Participants: 5
Study Start date:
January 01, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • UH Motol

    Prague, 15000
    Czechia

    Active - Recruiting

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