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Peripheral Nerve Injury Upper LimbNCT05207878

Interhemispheric Connectivity and Compensation

A study testing STEGA-MRI in people with Peripheral Nerve Injury Upper Limb and Healthy, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peripheral Nerve Injury Upper Limb, Healthy
What is being tested?
STEGA-MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
9 Dec 2021to 1 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

  1. Inclusion criteria (all participants):
  2. Age ≥ 18
  3. English speaking and reading
  4. Able to fit in Prisma scanner bore (60 cm diameter)
  5. Right hand dominant (self report, and Edinburgh handedness ≥ +40)
  6. Inclusion criteria (patients only):
  7. 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
  1. 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).
  1. Exclusion criteria (all participants)
  2. Currently intoxicated or otherwise non-compliant
  3. Chronic pain diagnosis unrelated to the nerve injury
  4. Uncorrected visual impairment that interferes with ability to see drawings in MRI
  5. Motor function diagnoses that affect function of the left hand, now or in past 2 years
  6. 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
  1. Upper extremity surgery, including peripheral nerve surgery, within last 2 months
  2. Contraindication for MRI
  3. Contraindication for transcranial magnetic stimulation (TMS)
  • May exclude from TMS only (since not all participants undergo TMS), or exclude from full study
  1. Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand)
  2. History of chronic cocaine use (based on medical record or volunteered; will not actively inquire)
  3. Diagnosis of schizophrenia or other rare psychiatric disorder
  • This is not meant to exclude depression or anxiety
  1. 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)
  1. Exclusion criteria (controls only)
  2. Motor function diagnoses that affect function of either hand, now or in past 2 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Interhemispheric Communication and Compensation in Peripheral Nerve Injury

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.

Read the 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.

Being tested
STEGA-MRI
Keywords
laterality of motor control, movement, functional magnetic resonance imaging, functional laterality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STEGA-MRIOther

    Precision drawing task (movement assessment)

Study groups in NCT05207878
Study groupRoleWhat they receive
Movement taskExperimentalAll 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.
Receives: Other: STEGA-MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 1

Secondary outcomes (2)

  1. Drawing smoothness

    Velocity smoothness in STEGA-MRI (Standardized Tracing Evaluation and Grapheme Assessment - MRI version) task

    Measured: Day 1

  2. Hand choice

    Percentage of grasps made with right hand

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start9 Dec 2021
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
The only "intervention" is the movement task. All participants receive the same task.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207878
Sponsor's protocol ID
202009183
Other IDs
R01NS114046-01A1
Status last verified
Aug 2026
First submitted
25 Dec 2021
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing STEGA-MRI in people with Peripheral Nerve Injury Upper Limb and Healthy, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD (blood oxygen level dependent) signal in ROIs (regions of interest) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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