ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing STDP After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

January 14, 2016
March 8, 2016
July 23, 2018
December 15, 2017
January 1, 2020   (Final data collection date for primary outcome measure)
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
Changes in amplitude of Motor evoked potential size [ Time Frame: post treatment at minute 0, minute 10, minute30, minute 60. ]
Complete list of historical versions of study NCT02701777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Enhancing STDP After Spinal Cord Injury
Maximizing Spike - Timing Dependent Plasticity After Spinal Cord Injury
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.
Not Provided
Interventional
Phase 4
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
Spinal Cord Injury
  • 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 .
  • Drug: Dextromethorphan
    150mg of DExtromethorphan pill will be administered
  • Drug: Seromycin Placebo
    placebo pill will be administered
  • Drug: Dextromethorphan Placebo
    placebo pill will be administered
  • Device: Sham STDP
    noninvasive magnetic or electrical sham stimulation will be applied to the brain
  • 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.
    Intervention: Device: STDP
  • 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.
    Interventions:
    • Drug: Seromycin
    • Device: STDP
    • Drug: Seromycin Placebo
  • 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.
    Interventions:
    • Device: STDP
    • Drug: Dextromethorphan
    • Drug: Dextromethorphan Placebo
  • Active Comparator: Training +STDP
    motor training exercises will be done repetitively and then stimulation (STDP) to the brain will be applied.
    Interventions:
    • Device: STDP
    • Other: Training
  • Active Comparator: Training
    motor training exercises will be done repetitively
    Intervention: Other: Training
  • 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
    Interventions:
    • Drug: Seromycin
    • Device: STDP
    • Other: Training
  • 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.
    Intervention: Device: Sham STDP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
January 1, 2021
January 1, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Yes
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
United States
 
 
NCT02701777
B1807-R
20151115 ( Other Identifier: University of Miami )
No
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
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
University of Miami
Principal Investigator: Martin Oudega, PhD Miami VA Healthcare System, Miami, FL
VA Office of Research and Development
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP