Epi Stim to Facilitate Standing and Stepping

Recruiting in Palo Alto (17 mi)

Overseen by Susan Harkema, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. The investigators propose that locomotor training will result in generation of more effective standing and stepping efferent patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The investigators propose that the SCES will optimize the physiological state of the spinal cord interneuronal circuitry compromised by compensating for loss of supraspinal input for the retraining of these tasks.

Research Team

Susan Harkema, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

Inclusion Criteria

stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with BWST;

no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;

no clinically significant depression or ongoing drug abuse;

Treatment Details

Interventions

• Spinal cord Epidural Stimulation (Spinal Cord Stimulation)

Participant Groups

Group I: Epidural Stimulator Experimental Treatment 1 Intervention

Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Louisville Louisville, KY

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Patients Recruited

76,400+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Patients Recruited

101,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Patients Recruited

21,600+

University of California, Los Angeles

Collaborator

Trials

1594

Patients Recruited

10,430,000+

Christopher Reeve Paralysis Foundation

Collaborator

Trials

6

Patients Recruited

1,800+

Kessler Foundation

Collaborator

Trials

190

Patients Recruited

11,300+