Spinal Cord Neuromodulation for SCI
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02313194 |
Recruitment Status :
Active, not recruiting
First Posted : December 9, 2014
Last Update Posted : November 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Spinal Cord Injury Tetraparesis Tetraplegia | Device: Epidural Stimulation Drug: Buspirone | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | July 2013 |
Estimated Primary Completion Date : | December 30, 2022 |
Estimated Study Completion Date : | December 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Stimulation
Determine if epidural stimulation can improve motor function.
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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. |
- Assessment of arm/hand function [ Time Frame: 24 months ]Formal motor testing

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Must not have disorders or conditions that would require MRI monitoring
Exclusion Criteria:
None as long as inclusion criteria are met.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313194
United States, California | |
UCLA | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Daniel C Lu, MD PhD | University of California, Los Angeles |
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: | December 9, 2014 Key Record Dates |
Last Update Posted: | November 24, 2021 |
Last Verified: | November 2021 |
Spinal Cord Injuries Quadriplegia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations Buspirone |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |