MEP Up-conditioning to Target Corticospinal Plasticity
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where participants receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor).
Investigators will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell investigators about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (≥18 yrs old)
A history of injury to spinal cord at or above C6
>6 months post SCI
Weak wrist extension at least unilaterally
Disqualifiers
Motoneuron injury
Medically unstable condition
Cognitive impairment
A history of epileptic seizures
Trial design
Design model
Single group
Treatments tested in this trial
Up-conditioning of the wrist extensor motor evoked potential
BehavioralAt the beginning of each session, EMG recording and nerve stimulating electrodes are placed over the arm. In all sessions, MEPs will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).
Treatment groups
11 Participants
are divided into 1 treatment groupGroup A: Operant Up-Conditioning of the Motor Evoked PotentialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Extensor Carpi Radialis (ECR) Motor Evoked Potential (MEP) amplitude
Size of MEP elicited at the fixed stimulus intensity (e.g., \~ 10-15% maximum stimulator output) of transcranial magnetic stimulation (TMS) above motor threshold) (in %M wave maximum amplitude)
Time frame
Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)Secondary outcomes
1
Maximum Voluntary Contraction - ECR
Maximum voluntary contraction measured by electromyography (EMG) (in mV); average of two trials
Time frame
Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)2
Capabilities Upper Extremity Test (CUE-T)
The CUE-T is an objective clinical measure of a person with tetraplegia's ability to complete actions with the arm and hand. This scale measures motor function. It consists of 19 tasks (17 unilateral, 2 bilateral). Scoring is based completion of the action, number of repetitions, or time to complete depending on the item and converted from raw score to 5-point scale (0-4, 4 is best).
Time frame
Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post3
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
The GRASSP is a clinical impairment measure to assess sensorimotor hand function in people with cervical SCI. The GRASSP tests 3 domains of hand function including strength, sensibility, and prehension. The GRASSP contains 6 tasks for each side scored from 0-5 for a possible score of 0-30 per side or 0-60 total, where higher scores are better.
Time frame
Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post4
Spinal Cord Independence Measure (SCIM III)
The SCIM is a self-report survey of daily activity independence in self-care, respiration and sphincter management, and mobility. The scores range from 0-100, where higher scores represent greater independence.
Time frame
Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months postOther outcomes
1
ECR MEP recruitment curve
Maximum MEP size (in mV and %maximum M-wave (Mmax)) and active MEP threshold (in %maximum stimulator output (MSO)
Time frame
Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post2
Silent Period Duration
Silent period duration measured as the time from the start of the MEP to the recovery of EMG activity to the prestimulus level (ms)
Time frame
Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)3
Spine imaging - lesion overlap with lateral corticospinal tract (LCST) or motor tract damage
Percent by volume of overlap between lesion and the LCST
Time frame
Baseline4
Spine imaging - Lesion volume
Volume of the lesion from the lesion segmentation in cubic millimeters
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
Doscher Neurorehabilitation Research Program
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov