Clinical trial NCT02701777: Enhancing STDP After Spinal Cord Injury
Official title: Maximizing Spike - Timing Dependent Plasticity After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spike timing dependant plasticity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: To induce STDP with paired pulse, corticospinal volleys evoked by either transcranial magnetic stimulation over the primary motor cortex for upper extremities or electrical stimulation over the thoracic spine for lower extremities arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles, 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of corresponding peripheral nerves.

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.

Primary outcomes:
measure: Functional Assessment
timeFrame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline, after 20 and 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Secondary outcomes:
measure: Amplitude of Motor Evoked Potential (MEP)
timeFrame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group.
measure: Maximum Voluntary Contraction
timeFrame: Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group.
measure: ISNCSCI-motor Scores
timeFrame: ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.
measure: ISNCSCI-sensory Scores
timeFrame: ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.
measure: SCI-QOL-ambulation
timeFrame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
measure: SCI-QOL-self-care
timeFrame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
measure: SCI-QOL- Bowel Management Difficulties
timeFrame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
measure: SCI-QOL- Bladder Management Difficulties
timeFrame: Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Martin Oudega, PhD
role: PRINCIPAL_INVESTIGATOR
References: