Enhancing STDP After Spinal Cord Injury

NCT ID: NCT02701777

Last Updated: 2022-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2020-10-30

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
participants will not know if they receive real or sham stimulation

Study Groups

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STDP

Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.

Group Type ACTIVE_COMPARATOR

STDP

Intervention Type OTHER

Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.

STDP + Training

Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.

Group Type ACTIVE_COMPARATOR

STDP

Intervention Type OTHER

Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.

Training

Intervention Type BEHAVIORAL

The participant will be asked to perform exercises using their hands and arms.

Sham STDP + Training

Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.

Group Type ACTIVE_COMPARATOR

Training

Intervention Type BEHAVIORAL

The participant will be asked to perform exercises using their hands and arms.

Sham STDP

Intervention Type OTHER

Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.

Multisite-STDP + Training

Prospective Single Cohort Multisite-Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.

Group Type OTHER

Training

Intervention Type BEHAVIORAL

The participant will be asked to perform exercises using their hands and arms.

Multisite-STDP

Intervention Type OTHER

Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.

Interventions

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STDP

Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.

Intervention Type OTHER

Training

The participant will be asked to perform exercises using their hands and arms.

Intervention Type BEHAVIORAL

Sham STDP

Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.

Intervention Type OTHER

Multisite-STDP

Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.

Intervention Type OTHER

Other Intervention Names

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Paired stimulation

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Oudega, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

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Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B1807-R

Identifier Type: -

Identifier Source: org_study_id

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