Clinical trial NCT05321017: Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
Official title: Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Quadriplegia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. a history of injury to spinal cord at or above C6
2. neurologically stable (\>6 mo post SCI)
3. medical clearance to participate
4. weak wrist extension at least unilaterally
5. expectation that current medication will be maintained without change for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. In participants with bilateral wrist extension weakness, the more severely impaired arm is studied.

Exclusion Criteria:

1. motoneuron injury
2. medically unstable condition
3. cognitive impairment
4. a history of epileptic seizures
5. metal implants in the cranium
6. implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
7. no measurable MEP elicited in the ECR
8. unable to produce any voluntary ECR EMG activity
9. extensive use of functional electrical stimulation to the arm on a daily basis
10. pregnancy (due to changes in 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 Motor Evoked Potential
timeFrame: Baseline and final training session (approximately 2.5 months)
measure: Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in gross manual dexterity as measured by the Box and Block Test (BBT)
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in strength as measured by Manual Muscle Testing (MMT)
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test
timeFrame: change from baseline to immediately after completing the training protocol
measure: Change in spasticity as measured by the Modified Ashworth Scale (mAS)
timeFrame: change from baseline to immediately after completing the training protocol
Secondary outcomes:
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: Blair Dellenbach, MSOT
role: PRINCIPAL_INVESTIGATOR
References: