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

Primary Purpose

Spinal Cord Injuries, Quadriplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MEP Operant Up-conditioning of the Wrist Extensor
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MEP Wrist Extensor Up-Conditioning

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
Decreased amount of time (s) to place and remove pegs in a peg board indicates improved fine motor ability and finger dexterity
Change in strength as measured by Manual Muscle Testing (MMT)
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 sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test
Ability to detect increasingly thinner monofilaments indicates increased sensation
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2022
Last Updated
March 30, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05321017
Brief Title
Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
Acronym
uMEP
Official Title
Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Quadriplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEP Wrist Extensor Up-Conditioning
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
MEP Operant Up-conditioning of the Wrist Extensor
Intervention Description
This 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.
Primary Outcome Measure Information:
Title
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the Motor Evoked Potential
Description
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)
Title
Change in ability to move the arm as measured by the Action Research Arm Test (ARAT). Maximum score of 57 points
Description
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 protocol
Title
Change in ability to move the arm as measured by the Fugl-Meyer Assessment (FMA)
Description
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 protocol
Title
Change in gross manual dexterity as measured by the Box and Block Test (BBT)
Description
An increased number of blocks moved in 60s indicates increased gross manual dexterity
Time Frame
change from baseline to immediately after completing the training protocol
Title
Change in fine motor ability and finger dexterity as measured by the Nine Hole Peg Test
Description
Decreased amount of time (s) to place and remove pegs in a peg board indicates improved fine motor ability and finger dexterity
Time Frame
change from baseline to immediately after completing the training protocol
Title
Change in strength as measured by Manual Muscle Testing (MMT)
Description
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.
Time Frame
change from baseline to immediately after completing the training protocol
Title
Change in sensation on the back and palm of the hand as measured by the Semmes Weinstein Monofilament Test
Description
Ability to detect increasingly thinner monofilaments indicates increased sensation
Time Frame
change from baseline to immediately after completing the training protocol
Title
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
Description
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Time Frame
change from baseline to immediately after completing the training protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: motoneuron injury medically unstable condition cognitive impairment a history of epileptic seizures metal implants in the cranium implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant) no measurable MEP elicited in the ECR unable to produce any voluntary ECR EMG activity extensive use of functional electrical stimulation to the arm on a daily basis pregnancy (due to changes in posture and potential medical instability).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blair Dellenbach, MSOT
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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