Medical University of South Carolina
Charleston, South Carolina, 29407, United States
Location status: Recruiting
Location contact
Aiko Thompson, PhD
PRINCIPAL_INVESTIGATOR
Blair Dellenbach, MSOT
CONTACT
NCT Number: NCT07179822
The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29407, United States
Location status: Recruiting
Aiko Thompson, PhD
PRINCIPAL_INVESTIGATOR
Blair Dellenbach, MSOT
CONTACT
Regaining arm/hand function is one of the top priorities of individuals with tetraplegia and is a challenging problem, partly due to the complex nature of upper limb motor function. Through mass practice and conventional therapy, functions can be restored partially, likely through compensation rather than induction of relevant corticospinal plasticity. In such cases, corticospinal recruitment of motoneurons and resulting muscle activation could remain impaired and continue to limit function recovery. In people with incomplete SCI, voluntary activation of the muscles below the injury level is often diminished, due at least partly to impaired motor unit behaviors. Abnormal motoneuron recruitment and motor unit firing, also found in other CNS disorders, would certainly hinder effective production of motor functions. Thus, to enhance upper limb motor rehabilitation beyond what conventional therapy has been able to achieve, a method to improve corticospinal recruitment of a targeted pool of motoneurons would be needed. Here, investigators hypothesize that wrist extensor MEP up-conditioning can improve forearm motor functions in people with cervical SCI by increasing the corticospinal excitability and improving corticospinal recruitment of wrist extensor motoneurons.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Operant conditioning is a method to induce behavioral learning based on the consequence (reward) of the behavior. With operant conditioning of the motor evoked potential (MEP), the neuronal excitability and behavior of the corticospinal pathway that involves production of MEP is targeted and trained (i.e., up-trained with up-conditioning). The individual is rewarded only for changing the target muscle's MEP size without changing background muscle activity. Since MEP size reflects the corticospinal excitability at or just before the time of stimulation, during MEP up-conditioning trials, the individual is urged to increase the corticospinal excitability for the target muscle.
Time frame: Baseline (average of 6 sessions over 2 weeks) and final phase (average of sessions 19-24 over weeks 7-8 of intervention)
MEP from each session is expressed as the percent of the initial MEP size (average MEP size from the 6 baseline sessions). The final MEP size is the fitted estimate of the MEP size at the end of 24 intervention sessions. MEP size is a measurement of the integrity of the corticospinal tract.
Time frame: Baseline (Week 0), mid-intervention (Week 5, after session 12), post-intervention (Week 9, after session 24), and follow-up at 1 month (Week 13) and 3 months (Week 21) post-intervention.
To measure basic functional independence, we will use the most recent version of the SCIM (SCIM III), which is self-reported and comprises 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, sub-score 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100. The items are weighted in terms of their presumed clinical relevance. SCIM score will be used for calculation of MCID.
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
Can MEP Conditioning Improve Corticospinal Recruitment of Motoneurons in Chronic Cervical SCI?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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