Spinal Cord Neuromodulation for SCI

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02313194
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 114
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spinal Cord Injury; Tetraparesis; Tetraplegia	Device: Epidural Stimulation; Drug: Buspirone	Phase 1/Phase 2

Detailed Description

An epidural stimulation device will be tested to determine if motor function can be improved.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stimulation Determine if epidural stimulation can improve motor function.	Device: Epidural Stimulation; Determine if epidural stimulation can improve motor function; Drug: Buspirone; Determine if the pharmacological agent in combination with the stimulator can improve motor function.

Outcome Measures

Primary Outcome Measures

1. Assessment of arm/hand function [24 months]

   Formal motor testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement

2. No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.

3. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training

4. No clinically significant depression or ongoing drug abuse

5. No current anti-spasticity medication regimen

6. Non-progressive SCI above C5

7. Must not have received botox injections in the prior six months

8. Be unable to grip or move independently

9. Be at least one-year post injury

10. Must be at least 18 years of age

11. Segmental reflexes remain functional below the lesion

12. Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception

13. No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation

14. No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery

15. Must not be involved in another clinical trial

16. Must not have disorders or conditions that would require MRI monitoring

Exclusion Criteria:

None as long as inclusion criteria are met.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Daniel C Lu, MD PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Lu, MD, PhD, Associate Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02313194
• Other Study ID Numbers: 12-001416
• First Posted: Dec 9, 2014
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Spinal Cord Injuries; Quadriplegia; Buspirone

Study Results

No Results Posted as of Nov 24, 2021