Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Quadriplegia
• Interventions: Behavioral: MEP Operant Up-conditioning of the Wrist Extensor

• Registration Number: NCT05321017
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEP Wrist Extensor Up-Conditioning	MEP Operant Up-conditioning of the Wrist Extensor	-

Primary Outcome Measures

Name	Time	Method
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)	change from baseline to immediately after completing the training protocol	An increase in the FMA score indicates better movement of the arm. Maximum score of 66 points
Change in strength as measured by Manual Muscle Testing (MMT)	change from baseline to immediately after completing the training protocol	Increased score on MMT indicates increased strength in the muscle being tested. The examiner grades the patient's strength on a 0 to 5 scale. 0: No muscle activation; 1: Trace muscle activation, such as a twitch, without achieving full range of motion; 2: Muscle activation with gravity eliminated, achieving full range of motion; 3: Muscle activation against gravity, full range of motion; 4: Muscle activation against some resistance, full range of motion; 5: Muscle activation against examiner's full resistance, full range of motion.
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test	change from baseline to immediately after completing the training protocol	Decreased amount of time (s) to place and remove pegs in a peg board indicates improved fine motor ability and finger dexterity
Change in spasticity as measured by the Modified Ashworth Scale (mAS)	change from baseline to immediately after completing the training protocol	The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points	change from baseline to immediately after completing the training protocol	An increase in ARAT score indicates an improvement in the ability to move the arm
Change in gross manual dexterity as measured by the Box and Block Test (BBT)	change from baseline to immediately after completing the training protocol	An increased number of blocks moved in 60s indicates increased gross manual dexterity
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential	Baseline and final training session (approximately 2.5 months)	An increased average MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Change in sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test	change from baseline to immediately after completing the training protocol	Ability to detect increasingly thinner monofilaments indicates increased sensation

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States