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Physiological Changes Induced Through MEP Conditioning in People With SCI

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ClinicalTrials.gov Identifier: NCT04286191
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aiko Thompson, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE February 26, 2020
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE February 22, 2021
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
  • Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
  • Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
  • Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI) [ Time Frame: Baseline through 3 months post intervention ]
    Decreased SICI indicates increased excitability in the brain
  • Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
  • Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
  • Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
  • Change in ankle joint motion during walking (deg)--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
  • Change in walking speed (m/s) as measured by the 10-meter walk test [ Time Frame: Baseline through 3 months post intervention ]
    Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
  • Change in walking distance (meters) as measured by the 6-minute walk test [ Time Frame: Baseline through 3 months post intervention ]
    The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
  • Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
  • Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
  • Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
  • Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
  • Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Contralateral Leg [ Time Frame: Baseline through 3 months post intervention ]
    Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
  • Change in ankle joint motion during walking (deg)--Studied Leg [ Time Frame: Baseline through 3 months post intervention ]
    Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
  • Change in knee joint motion during walking (deg)--Both Legs [ Time Frame: Baseline through 3 months post intervention ]
    Knee range of motion over the step cycle (in deg); knee peak flexion angle (in deg); knee peak extension angle (in deg); knee angle at foot contact (in deg); median knee angle over the step cycle (in deg)
  • Change in hip joint motion during walking (deg)--Both Legs [ Time Frame: Baseline through 3 months post intervention ]
    Hip range of motion over the step cycle (in deg); hip peak flexion angle (in deg); hip peak extension angle (in deg); hip angle at foot contact (in deg); median hip angle over the step cycle (in deg)
  • Changes in reflexes and muscle activation during walking as measured by H-reflex size and cutaneous reflex size [ Time Frame: Baseline through 3 months post intervention ]
    Decreased H-reflex response and decreased radiating threshold of the cutaneous reflex would reflect reflex activity that is more similar to individuals without neurological injury
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological Changes Induced Through MEP Conditioning in People With SCI
Official Title  ICMJE Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury
Brief Summary

The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.

Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.

Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Neurological Injury
  • Paralysis
  • Spasticity, Muscle
Intervention  ICMJE
  • Combination Product: Operant Conditioning
    This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
  • Combination Product: Control Group
    This is the control intervention, or the non-conditioning group. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
Study Arms  ICMJE
  • Experimental: Up-conditioning (UC) Group
    Intervention: Combination Product: Operant Conditioning
  • Sham Comparator: Control (NC) Group
    Intervention: Combination Product: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Neurologically stable (>1 year post SCI)
  • Medical clearance to participate
  • Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
  • Signs of weak ankle dorsiflexion at least unilaterally
  • Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted

Exclusion Criteria:

  • motoneuron injury
  • known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
  • medically unstable condition
  • cognitive impairment
  • history of epileptic seizures
  • metal implants in the cranium
  • implanted biomedical device in or above the ches (e.g., a cardiac pacemaker, cochlear implant)
  • no measurable MEP elicited
  • unable to produce any voluntary TA EMG activity
  • extensive use of functional electrical stimulation to the leg on a daily basis
  • pregnancy (due to changes in weight and posture and potential medical instability)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Blair Dellenbach, MSOT 843-792-6313 stecb@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04286191
Other Study ID Numbers  ICMJE 00091457
1R01NS114279-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aiko Thompson, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Aiko K Thompson, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2021

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