NCT05207878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

December 25, 2021

Last Update Submit

October 7, 2025

Conditions

Keywords

laterality of motor controlmovementfunctional magnetic resonance imagingfunctional laterality

Outcome Measures

Primary Outcomes (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)

    Day 1

Secondary Outcomes (2)

  • Drawing smoothness

    Day 1

  • Hand choice

    Day 1

Study Arms (1)

Movement task

EXPERIMENTAL

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.

Other: STEGA-MRI

Interventions

Precision drawing task (movement assessment)

Movement task

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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).

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Study Officials

  • Benjamin A Philip, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
During TMS, participants will be masked to whether they receive effective or sham stimulation on a given trial.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The only "intervention" is the movement task. All participants receive the same task.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 26, 2022

Study Start

December 9, 2021

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Will become available after summary data are published. Will remain available indefinitely.

Locations