Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm.
It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI).
This study requires 30 visits, and each visit will last approximately 1.5 hours.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a history of injury to spinal cord at or above C6
neurologically stable (>6 mo post SCI)
medical clearance to participate
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
MEP Operant Up-conditioning of the Wrist Extensor
BehavioralThis 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 wrist extensor (extensor carpi radialis), the muscle the bends the wrist back.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: MEP Wrist Extensor Up-ConditioningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential
An increased average MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Time frame
Baseline and final training session (approximately 2.5 months)2
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
An increase in ARAT score indicates an improvement in the ability to move the arm
Time frame
change from baseline to immediately after completing the training protocol3
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
An increase in the FMA score indicates better movement of the arm. Maximum score of 66 points
Time frame
change from baseline to immediately after completing the training protocol4
Change in gross manual dexterity as measured by the Box and Block Test (BBT)
An increased number of blocks moved in 60s indicates increased gross manual dexterity
Time frame
change from baseline to immediately after completing the training protocolSponsors and contacts
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Source ClinicalTrials.gov