N/A
N=62
Enhancing STDP After Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02701777 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Functional Assessment — 100; 100; 100; 100 percentage of Baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STDP (Other); Training (Behavioral); Sham STDP (Other); Multisite-STDP (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Assessment |
100; 100; 100; 100; 80.5; 75.6 | — |
| SECONDARY Amplitude of Motor Evoked Potential (MEP) |
100; 100; 100; 100; 153.2; 164.6 | — |
| SECONDARY Maximum Voluntary Contraction |
100; 100; 100; 100; 139.4; 144.6 | — |
| SECONDARY ISNCSCI-motor Scores |
59.4; 68.9 | — |
| SECONDARY ISNCSCI-sensory Scores |
99.0; 119.9 | — |
| SECONDARY SCI-QOL-ambulation |
53.7; 57.1; 61.4 | — |
| SECONDARY SCI-QOL-self-care |
45.9; 47.5; 48.5 | — |
| SECONDARY SCI-QOL- Bowel Management Difficulties |
48.2; 51.8; 45.4 | — |
| SECONDARY SCI-QOL- Bladder Management Difficulties |
41.0; 46.7; 40.9 | — |
Summary
The overall goal is to develop new clinical approaches to restore limb function after spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function. Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements in limb function in humans with incomplete SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.
Eligibility Criteria
Inclusion Criteria
Participants who are unimpaired healthy controls:
- Male and females between ages 18-85 years
- Right handed
- Able to complete precision grips with both hands
- Able to complete full wrist flexion-extension bilaterally
- Able to walk unassisted
- Able to complete full ankle flexion-extension bilaterally
Participants who have had a spinal cord injury:
- Male and females between ages 18-85 years
- SCI ( 6 months of injury)
- Spinal Cord injury at or above L5
- The ability to produce a visible precision grip force with one hand
- Able to perform some small wrist flexion and extension
- The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles
- No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.
- ASIA A,B,C, or D
Exclusion Criteria
Exclusion criteria for enrollment For SCI and Healthy Control Subjects (4-8 exclusion for non-invasive brain stimulation only):
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
- Pregnant females
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.
Data sourced from ClinicalTrials.gov (NCT02701777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.