- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05207878
Interhemispheric Connectivity and Compensation
Interhemispheric Communication and Compensation in Peripheral Nerve Injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63108
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Movement task
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. |
Precision drawing task (movement assessment)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)
Time Frame: Day 1
|
BOLD signal in key ROIs (primary motor and posterior parietal cortex).
ROI selection may be revisited after preliminary data review (35 participants)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drawing smoothness
Time Frame: Day 1
|
Velocity smoothness in STEGA-MRI (Standardized Tracing Evaluation and Grapheme Assessment - MRI version) task
|
Day 1
|
|
Hand choice
Time Frame: Day 1
|
Percentage of grasps made with right hand
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin A Philip, PhD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202009183
- R01NS114046-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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