Spinal Cord Neuromodulation for Spinal Cord Injury

Tetraplegia Clinical Trial

Official title:

Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02313194
• Other study ID #: 12-001416
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2013
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Quadriplegia
• Spinal Cord Injuries
• Tetraparesis
• Tetraplegia

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of arm/hand function	Formal motor testing	24 months