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Interhemispheric Connectivity and Compensation

Primary Purpose

Peripheral Nerve Injury Upper Limb, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEGA-MRI
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Nerve Injury Upper Limb focused on measuring laterality of motor control, movement, functional magnetic resonance imaging, functional laterality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

This study contains two groups: typical controls and patients. Participants will be matched by age and sex between the two groups. No randomization will occur.

A. Inclusion criteria (all participants):

  1. Age ≥ 18
  2. English speaking and reading
  3. Able to fit in Prisma scanner bore (60 cm diameter)
  4. Right hand dominant (self report, and Edinburgh handedness ≥ +40)

B. Inclusion criteria (patients only):

  1. Chronic unilateral upper extremity peripheral nerve injury to the right side

    • "Chronic" defined as ≥ 6 months since injury
    • "Upper extremity" defined as hand, arm, or shoulder (including e.g. brachial plexus)
    • "Injury" defined as localized cause (e.g. mechanical/tumor, not distributed pathology), including compression
  2. Some impairment to writing, requiring both of:

    • Difficulty writing, as determined by score 2+ (Mild+) on "How much difficulty have you had in the last week with writing?" (From Disabilities of the Arm, Shoulder, and Hand survey question #2)
    • Box and Blocks motor performance ≥1 standard deviation below the mean of age-matched healthy adults (Mathiowetz et al. 1985, AJOT).

C. Exclusion criteria (all participants)

  1. Chronic pain diagnosis unrelated to the nerve injury
  2. Uncorrected visual impairment that interferes with ability to see drawings in MRI
  3. Motor function diagnoses that affect the left arm, now or in past 2 years
  4. Motor function diagnoses currently affecting the right hand, unrelated to the nerve injury

    • This is not meant to exclude a single event with complex consequences (e.g. nerve and tendon)
    • This is not meant to exclude multiple nerve injuries in the same arm, if each one is eligible (II.B.1)
    • This is meant to exclude e.g. injury and unrelated musculoskeletal disorder in same arm
  5. Upper extremity surgery, including peripheral nerve surgery, within last 2 months
  6. Contraindication for MRI
  7. Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand)
  8. Diagnosis of schizophrenia or other rare psychiatric disorder

    • This is not meant to exclude depression or anxiety
  9. History of major neurological diagnosis, e.g. stroke, traumatic brain injury, Alzheimer's, Parkinson's

    • This is not meant to exclude concussion UNLESS < 6 months ago, or post-concussion syndrome (diagnosed or self-report)

D. Exclusion criteria (controls only)

1. Motor function diagnoses that affect either arm, now or in past 2 years

E. Transcranial magnetic stimulation (TMS) Some participants from both groups may receive transcranial magnetic stimulation (TMS). If these participants have contraindication for TMS (e.g. family history of seizure disorder), these patients will be excluded from the study or excluded from TMS.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Movement task

Arm Description

All participants perform the STEGA-MRI (standardized tracing evaluation & grapheme assessment - MRI) precision drawing task during fMRI scanning. Motor assessments outside the MRI do not qualify as interventions.

Outcomes

Primary Outcome Measures

BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)
BOLD signal in key ROIs (primary motor and posterior parietal cortex). ROI selection may be revisited after preliminary data review (35 participants)

Secondary Outcome Measures

Drawing smoothness
Velocity smoothness in STEGA-MRI (Standardized Tracing Evaluation and Grapheme Assessment - MRI version) task
Hand choice
Percentage of grasps made with right hand

Full Information

First Posted
December 25, 2021
Last Updated
January 27, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05207878
Brief Title
Interhemispheric Connectivity and Compensation
Official Title
Interhemispheric Communication and Compensation in Peripheral Nerve Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

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 goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand.
Detailed Description
This is a one-visit study, in which right-handed participants (individuals with unilateral peripheral nerve injury to the right upper limb, and healthy controls) will complete surveys and perform movement tasks. Movement tasks will be performed inside and outside a magnetic resonance imaging (MRI) scanner. Some participants will also receive transcranial magnetic stimulation (TMS) to briefly interfere with these putative brain networks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury Upper Limb, Healthy
Keywords
laterality of motor control, movement, functional magnetic resonance imaging, functional laterality

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The only "intervention" is the movement task. All participants receive the same task.
Masking
None (Open Label)
Masking Description
During TMS, participants will be masked to whether they receive effective or sham stimulation on a given trial.
Allocation
N/A
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Movement task
Arm Type
Experimental
Arm Description
All participants perform the STEGA-MRI (standardized tracing evaluation & grapheme assessment - MRI) precision drawing task during fMRI scanning. Motor assessments outside the MRI do not qualify as interventions.
Intervention Type
Other
Intervention Name(s)
STEGA-MRI
Intervention Description
Precision drawing task (movement assessment)
Primary Outcome Measure Information:
Title
BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)
Description
BOLD signal in key ROIs (primary motor and posterior parietal cortex). ROI selection may be revisited after preliminary data review (35 participants)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Drawing smoothness
Description
Velocity smoothness in STEGA-MRI (Standardized Tracing Evaluation and Grapheme Assessment - MRI version) task
Time Frame
Day 1
Title
Hand choice
Description
Percentage of grasps made with right hand
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
This study contains two groups: typical controls and patients. Participants will be matched by age and sex between the two groups. No randomization will occur. A. Inclusion criteria (all participants): Age ≥ 18 English speaking and reading Able to fit in Prisma scanner bore (60 cm diameter) Right hand dominant (self report, and Edinburgh handedness ≥ +40) B. Inclusion criteria (patients only): Chronic unilateral upper extremity peripheral nerve injury to the right side "Chronic" defined as ≥ 6 months since injury "Upper extremity" defined as hand, arm, or shoulder (including e.g. brachial plexus) "Injury" defined as localized cause (e.g. mechanical/tumor, not distributed pathology), including compression Some impairment to writing, requiring both of: Difficulty writing, as determined by score 2+ (Mild+) on "How much difficulty have you had in the last week with writing?" (From Disabilities of the Arm, Shoulder, and Hand survey question #2) Box and Blocks motor performance ≥1 standard deviation below the mean of age-matched healthy adults (Mathiowetz et al. 1985, AJOT). C. Exclusion criteria (all participants) Currently intoxicated or otherwise non-compliant Chronic pain diagnosis unrelated to the nerve injury Uncorrected visual impairment that interferes with ability to see drawings in MRI Motor function diagnoses that affect function of the left hand, now or in past 2 years Motor function diagnoses currently affecting the right hand, unrelated to the nerve injury This is not meant to exclude a single event with complex consequences (e.g. nerve and tendon) This is not meant to exclude multiple nerve injuries in the same arm, if each one is eligible (II.B.1) This is meant to exclude e.g. injury and unrelated musculoskeletal disorder in same arm Upper extremity surgery, including peripheral nerve surgery, within last 2 months Contraindication for MRI Contraindication for transcranial magnetic stimulation (TMS) May exclude from TMS only (since not all participants undergo TMS), or exclude from full study Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand) History of chronic cocaine use (based on medical record or volunteered; will not actively inquire) Diagnosis of schizophrenia or other rare psychiatric disorder This is not meant to exclude depression or anxiety History of major neurological diagnosis, e.g. stroke, traumatic brain injury, Alzheimer's, Parkinson's This is not meant to exclude concussion UNLESS < 6 months ago, or post-concussion syndrome (diagnosed or self-report) D. Exclusion criteria (controls only) 1. Motor function diagnoses that affect function of either hand, now or in past 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin A Philip, PhD
Phone
‭(314) 286-1634‬
Email
bphilip@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Setsu Uzume
Phone
‭(314) 747-7724‬
Email
setsu@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin A Philip, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin A Philip, PhD
First Name & Middle Initial & Last Name & Degree
Ian Dobbins, PhD
First Name & Middle Initial & Last Name & Degree
Alexandre Carter, MD
First Name & Middle Initial & Last Name & Degree
Yong Wang, PhD
First Name & Middle Initial & Last Name & Degree
Lei Liu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
For participants who consent to us sharing their data with other researchers, we will share all anonymized data (behavioral, survey, and MRI), including data dictionaries. Note that this clinical trial is a "prospective basic science study involving human participants;" i.e., a study that falls within the NIH definition of clinical trial while also meeting the definition of basic research.
IPD Sharing Time Frame
Will become available after summary data are published. Will remain available indefinitely.

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Interhemispheric Connectivity and Compensation

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