Clinical trial NCT05207878: Interhemispheric Connectivity and Compensation
Official title: Interhemispheric Communication and Compensation in Peripheral Nerve Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Nerve Injury Upper Limb
Healthy
Keywords: laterality of motor control
movement
functional magnetic resonance imaging
functional laterality
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-01-26
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The only "intervention" is the movement task. All participants receive the same task.
Primary purpose: BASIC_SCIENCE

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.

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):

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. Currently intoxicated or otherwise non-compliant
2. Chronic pain diagnosis unrelated to the nerve injury
3. Uncorrected visual impairment that interferes with ability to see drawings in MRI
4. Motor function diagnoses that affect function of the left hand, now or in past 2 years
5. 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
6. Upper extremity surgery, including peripheral nerve surgery, within last 2 months
7. Contraindication for MRI
8. Contraindication for transcranial magnetic stimulation (TMS)

   * May exclude from TMS only (since not all participants undergo TMS), or exclude from full study
9. Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand)
10. History of chronic cocaine use (based on medical record or volunteered; will not actively inquire)
11. Diagnosis of schizophrenia or other rare psychiatric disorder

    * This is not meant to exclude depression or anxiety
12. 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

Primary outcomes:
measure: BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)
timeFrame: Day 1
Secondary outcomes:
measure: Drawing smoothness
timeFrame: Day 1
measure: Hand choice
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Benjamin A Philip, PhD
role: PRINCIPAL_INVESTIGATOR
References: