Spinal Cord Neuromodulation for Spinal Cord Injury

NCT02313194 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 12-001416
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spinal Cord Injury; Tetraparesis; Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Assessment of arm/hand function

  Formal motor testing

  24 months

Study Arms (1)

Stimulation

EXPERIMENTAL

Determine if epidural stimulation can improve motor function.

Device: Epidural Stimulation; Drug: Buspirone

Interventions

Epidural Stimulation DEVICE

Determine if epidural stimulation can improve motor function

Stimulation

Buspirone DRUG

Determine if the pharmacological agent in combination with the stimulator can improve motor function.

Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
• No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
• No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
• No clinically significant depression or ongoing drug abuse
• No current anti-spasticity medication regimen
• Non-progressive SCI above C5
• Must not have received botox injections in the prior six months
• Be unable to grip or move independently
• Be at least one-year post injury
• Must be at least 18 years of age
• Segmental reflexes remain functional below the lesion
• Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
• No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
• No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
• Must not be involved in another clinical trial

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Quadriplegia

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Daniel C Lu, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: July 1, 2013
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)