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Enhancing STDP After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02701777
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The overall goal is to develop new clinical approaches to restore upper-limb function after incomplete cervical spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling upper-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 upper-limb function in humans with incomplete cervical SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Seromycin Device: STDP Other: Training Drug: Dextromethorphan Drug: Seromycin Placebo Drug: Dextromethorphan Placebo Device: Sham STDP Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Magnetic Stimulation and electrical stimulation
Masking: Single (Participant)
Masking Description: participants will not know if they receive real or sham stimulation
Primary Purpose: Treatment
Official Title: Maximizing Spike - Timing Dependent Plasticity After Spinal Cord Injury
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: STDP
paired stimulation will be given to the brain so that the messages are received at the spinal cord at the correct time.
Device: STDP
noninvasive magnetic or electrical stimulation will be applied to the brain

Active Comparator: STDP+ Seromycin/ Placebo
a single dose of 100mg of Seromycin will be given in a pill form by mouth and then paired stimulation will be applied to the brain so that the messages are received at the spinal cord at the correct time.
Drug: Seromycin
100mg pill of Seromycin by mouth will be administered

Device: STDP
noninvasive magnetic or electrical stimulation will be applied to the brain

Drug: Seromycin Placebo
placebo pill will be administered

Active Comparator: STDP+Dextromethorphan/ Placebo
a single dose of 150mg of Dextromethorphan will be given in a pill form by mouth and then paired stimulation (STDP) will be applied to the brain so that the messages are received at the spinal cord at the correct time.
Device: STDP
noninvasive magnetic or electrical stimulation will be applied to the brain

Drug: Dextromethorphan
150mg of DExtromethorphan pill will be administered

Drug: Dextromethorphan Placebo
placebo pill will be administered

Active Comparator: Training +STDP
motor training exercises will be done repetitively and then stimulation (STDP) to the brain will be applied.
Device: STDP
noninvasive magnetic or electrical stimulation will be applied to the brain

Other: Training
following the directions of the researcher the participant will be asked to perform specific repetitive movements using their hand, arm or leg .

Active Comparator: Training
motor training exercises will be done repetitively
Other: Training
following the directions of the researcher the participant will be asked to perform specific repetitive movements using their hand, arm or leg .

Active Comparator: Training + Seromycin+STDP/ Sham STDP
Motor Training will be completed, then a single dose of 100 mg of Seromycin will be administered in pill form, and then stimulation or sham stimulation will be applied to the brain
Drug: Seromycin
100mg pill of Seromycin by mouth will be administered

Device: STDP
noninvasive magnetic or electrical stimulation will be applied to the brain

Other: Training
following the directions of the researcher the participant will be asked to perform specific repetitive movements using their hand, arm or leg .

Active Comparator: Sham STDP
fake stimulation will be given to the brain so that the messages are received at the spinal cord at the correct time.
Device: Sham STDP
noninvasive magnetic or electrical sham stimulation will be applied to the brain




Primary Outcome Measures :
  1. Changes in amplitude of Motor evoked potential size [ Time Frame: post treatment at minute 0, minute 10, minute30, minute 60. ]
    at the stated minute interval measurements are reassessed to effect



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ( 2 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.

Information from the National Library of Medicine

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): NCT02701777


Contacts
Contact: Francisco D Benavides, MD (305) 575-7000 ext 3179 franciscodavid.benavidesjaramillo@va.gov
Contact: Monica A Perez, PhD (412) 383-6563 perezmo@miami.edu

Locations
United States, Florida
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Francisco D Benavides, MD    305-575-7000 ext 3179    franciscodavid.benavidesjaramillo@va.gov   
Principal Investigator: Martin Oudega, PhD         
Sponsors and Collaborators
VA Office of Research and Development
University of Miami
Investigators
Principal Investigator: Martin Oudega, PhD Miami VA Healthcare System, Miami, FL

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02701777     History of Changes
Other Study ID Numbers: B1807-R
20151115 ( Other Identifier: University of Miami )
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
spike timing dependant plasticity

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Dextromethorphan
Cycloserine
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites