Clinical trial NCT04286191: Physiological Changes Induced Through MEP Conditioning in People With SCI
Official title: Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neurological Injury
Paralysis
Spasticity, Muscle
Keywords: Corticospinal Tract
Neuroplasticity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)
timeFrame: Baseline through 3 months post intervention
measure: Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Studied Leg
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: Change in ankle joint motion during walking (deg)--Studied Leg
timeFrame: Baseline through 3 months post intervention
measure: Change in walking speed (m/s) as measured by the 10-meter walk test
timeFrame: Baseline through 3 months post intervention
measure: Change in walking distance (meters) as measured by the 6-minute walk test
timeFrame: Baseline through 3 months post intervention
Secondary outcomes:
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Contralateral Leg
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: 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
timeFrame: Baseline through 3 months post intervention
measure: Change in ankle joint motion during walking (deg)--Studied Leg
timeFrame: Baseline through 3 months post intervention
measure: Change in knee joint motion during walking (deg)--Both Legs
timeFrame: Baseline through 3 months post intervention
measure: Change in hip joint motion during walking (deg)--Both Legs
timeFrame: Baseline through 3 months post intervention
measure: Changes in reflexes and muscle activation during walking as measured by H-reflex size and cutaneous reflex size
timeFrame: Baseline through 3 months post intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aiko K Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: