Enhancing STDP After Spinal Cord Injury

NCT02701777 | Completed Results

• 1 other identifier: B1807-R
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spike timing dependant plasticity

Outcome Measures

Primary Outcomes (1)

• Functional Assessment

  The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) assessment is a standardized test of functional abilities of the hand. We measure time required to complete the GRASSP test for upper extremity functional assessment. 10-m walk test is used to measure walking speed for lower extremity functional assessment. The time to complete the task is assessed in seconds for both measurements and normalized as percentage of Baseline. Normalization to baseline allows comparison across two different tasks. For STDP, STDP+Training, and Sham-STDP+Training groups, either GRASSP or 10-m walk test was performed in each participant depending on the targeted muscle. For Multisite-STDP + Training group, both GRASSP and 10-m walk test were performed in each participant and the average of two tests were reported below.

  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 (8)

• Amplitude of Motor Evoked Potential (MEP)

  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.

• Maximum Voluntary Contraction

  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.

• ISNCSCI-motor Scores

  ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.

• ISNCSCI-sensory Scores

  ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training.

• SCI-QOL-ambulation

  Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group.

Study Arms (4)

STDP

ACTIVE COMPARATOR

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.

Other: STDP

STDP + Training

ACTIVE COMPARATOR

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.

Other: STDP; Behavioral: Training

Sham STDP + Training

ACTIVE COMPARATOR

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.

Behavioral: Training; Other: Sham STDP

Multisite-STDP + Training

OTHER

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.

Behavioral: Training; Other: Multisite-STDP

Interventions

STDP 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.

Also known as: Paired stimulation

STDP; STDP + Training

Training BEHAVIORAL

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

Multisite-STDP + Training; STDP + Training; Sham STDP + Training

Sham STDP 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.

Sham STDP + Training

Multisite-STDP 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.

Multisite-STDP + Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Reagan Morehouse
• Organization: Hines VA

rmorehouse@sralab.org

312-238-2993

Study Officials

• Martin Oudega, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will not know if they receive real or sham stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 21, 2022
• Results First Posted: January 20, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)