- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05124301
Neural Basis of Sensory and Motor Learning: Functional Connections
Study Overview
Detailed Description
Human perception of hand position is multisensory. The brain can estimate it visually, from an image on the retina, and proprioceptively, from receptors in the joints and muscles. The sensory inputs determining these percepts are subject to changes in environmental factors (e.g., lighting) and internal factors (e.g., movement history). Multisensory integration of visual and proprioceptive estimates gives us flexibility to cope with such changes. For example, washing dishes with the hands immersed in water creates a spatial misalignment between vision and proprioception, as water refracts light. The brain resolves this conflict by realigning visual and/or proprioceptive estimates of hand position, and also by adjusting motor commands (visuomotor adaptation). The neural basis of these adaptive processes is poorly understood. The purpose of this study is to find out if multisensory and visuomotor learning are accompanied by changes in resting state connectivity between sensory regions of the brain and other areas.
The first session is a familiarization session for functional magnetic resonance imaging (fMRI) and the behavioral task, and is expected to last 30-40 minutes. Subjects will first fill out screening forms to confirm the answers given during the initial screening, and the Edinburgh handedness inventory to quantify their handedness. If subjects are still eligible, subjects will lie in a mock scanner and perform the functional task: Subjects will have their left index finger taped to a wooden stick, and an experimenter from the team will manipulate the finger with the stick outside of the scanner. Subjects will respond to the different movements by pressing buttons with their right hand. Subjects will also be introduced to the behavioral task, which is performed at an apparatus in the room next to the scanner: Subjects sit in front of a touchscreen and point to targets seen in a mirror.
If subjects are interested in moving on to the main session at this point, the main session will be scheduled.
The main session will take about 2 hours. Subjects will first fill out the MR safety screening form. Subjects will then perform some practice trials of the behavioral task to remind the subject of the task. This will be followed by the first resting state scan (12 min), a 20-30 minute baseline block of the behavioral task (no learning), a second resting state scan (12 min), the 20-30 minute learning block of the behavioral task, and a third resting state scan (12 min). Finally, the subject will do the functional task in the scanner (same as familiarization session, 12 min. total) and an anatomical scan (~6 minutes). The session will conclude with some questions about the subject's subjective experience of the procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Bloomington, Indiana, United States, 47405
- Indiana University Bloomington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages of 18-45 years old
- Right-handed.
- Free of Covid symptoms in week preceding testing.
Exclusion Criteria:
- metallic, mechanical, or magnetic implants;
- are claustrophobic, or are unable to remain still for long periods of time;
- use an intra-uterine device (IUD) whos MR compatibility has not been established.
- Women who are pregnant or think they might be pregnant will also be excluded, as effects of fMRI on the unborn are not known.
- People who have a BMI over 30 will be excluded as it may be uncomfortable or impossible to lay in the MRI scanner and reach the button box.
- Potential subjects will be excluded if they have any neurological disorders, or orthopedic or pain conditions in the upper limbs.
- Investigators will also exclude subjects who do not have normal vision, or corrected-to-normal vision with contacts, or the imaging center does not have a pair of MRI compatible glasses that fits their prescription.
- investigators will invite subjects to reschedule if they have any of the common Covid symptoms within the last week and if they haven't been fully vaccinated or obtained a negative Covid test within the past 4 days. If they don't believe they can meet these criteria on another date, they will be excluded.
- After giving their consent, participants may be excluded during the study if they are unable to perform the tasks or follow instructions.
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 |
|---|---|
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Experimental: Perceptual learning
Reaching task in which visual information about target finger position is offset to induce a change in perception of the finger.
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Reaching task with visual feedback offset from target finger position.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting-state PMv-M1 Functional Connectivity (Fisher Z-transformed Correlation)
Time Frame: 3 scans during the main session (2 hours)
|
Brain activity was measured during a 12-minute resting-state functional magnetic resonance imaging (fMRI) scan.
Resting-state functional connectivity between the ventral premotor cortex (PMv) and primary motor cortex (M1) was quantified as the Pearson correlation coefficient between the mean blood-oxygen-level-dependent (BOLD) time series extracted from anatomically defined PMv and M1 regions of interest.
Correlation coefficients were Fisher z-transformed to improve normality.
For each participant, connectivity values were averaged across all scans acquired during the main session.
The outcome measure is the mean Fisher z-transformed correlation value (unitless).
Numbers range from -1 (opposite activity in the two regions) to 1 (similar activity in the two regions), with 0 implying no relationship between the two regions.
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3 scans during the main session (2 hours)
|
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Weighting of Vision vs. Proprioception
Time Frame: Measured during the main session (2 hours)
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Measured by comparing where subjects point on the touchscreen when they are estimating visual vs. proprioceptive targets.
A person who relies only on vision would have a weighting value of 100%.
A person who relies only on proprioception would have a weighting of 0%.
A value of 50% would imply equal reliance on vision and proprioception.
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Measured during the main session (2 hours)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hannah Block, Indiana University, Bloomington
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13138
- R01NS112367-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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