fNIRS Grasping Task in Infants

August 22, 2025 updated by: University Ghent

Brain Function During Grasping Task in Three to Nine Months Infants Using fNIRS , the Difference Between Full and Preterm Born Infants

This study aims to investigate the neural mechanisms involved in the development of reach-to-grasp function in infants. Reaching and grasping are crucial motor skills that develop early in infancy and are essential for later motor and cognitive milestones. Understanding how these skills emerge and the underlying neural processes can provide valuable insights into both typical and atypical development.

The study will focus on infants aged 3 to 9 months, a critical period for the development of reach-to-grasp skills. A total of 100 infants will be recruited, including 50 full-term infants and 50 preterm infants (born <36 weeks gestational age). Reach-to-grasp function will be evaluated through a cross-sectional assessment at a single time point. Functional near-infrared spectroscopy (fNIRS) will be used as the brain imaging technique to measure brain activity during the reach-to-grasp task. The use of fNIRS will allow for a non-invasive assessment of neural activity in real time, providing insights into the brain mechanisms supporting the development of motor skills. The findings may offer important information about the neural basis of motor development in infancy, particularly in the context of preterm birth.

Study Overview

Status

Recruiting

Detailed Description

This study aims to investigate the neural mechanisms underlying the development of grasping function in infants aged 3 to 9 months. Specifically, it focuses on brain activity linked to reach-to-grasp movements, the role of maturation in this brain activity, the effect of preterm birth, and brain activity during bimanual toy exploration. The study will recruit 100 infants, including 50 full-term infants and 50 preterm infants (born at less than 36 weeks gestational age). Functional Near-Infrared Spectroscopy (fNIRS) will be used as the brain imaging technique to assess neural activity.

Objectives:

To investigate differences in brain activity during the reach-to-grasp task in 3-9-month-old infants between preterm and full-term infants.

To evaluate differences in the neural correlates of maturation of the reach-to-grasp motor skill.

To investigate differences in laterality index between preterm and full-term infants during bimanual toy exploration.

Method:

Fifty preterm and fifty full-term infants between 3 and 9 months corrected age will be assessed at a single time point. The assessment consists of an fNIRS event-related reach-to-grasp task protocol, where infants are encouraged to reach and grasp a toy, measured using the NSP2 system (NIRx). The task protocol includes 10 repetitions of each reach-to-grasp condition: 5 seconds of left-hand reach-to-grasp, 5 seconds of right-hand reach-to-grasp, and 10 seconds of bimanual toy exploration. A 10-second rest period is implemented between each reach-to-grasp action, and a 30-second rest period is implemented between conditions. Additionally, 5-7 minutes of resting-state fNIRS data will be recorded while infants watch a screensaver-like video to help maintain a resting state.

The fNIRS cap configuration consists of an 8×8 optode array covering the sensorimotor cortex. Cap size is adapted to the infant's head circumference (ranging between 42 and 46 cm), with the optode configuration remaining consistent across all cap sizes.

In addition to the fNIRS assessment, two clinical assessments will be conducted:

Hand Assessment for Infants (HAI): Evaluates hand function in infants. Hammersmith Infant Neurological Examination (HINE): Assesses neurological development.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • hent University, vakgroep revalidatiewetenschappen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nele De Bruyn, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

infants between 3 an 9 months old, living in Flanders (Belgium) born full term or preterm.

Description

Inclusion Criteria:

  • 3-9 months old
  • can tolerate the fNIRS cap
  • performs at least 2 grapsing attempts with one hand within one minute when prompting the hand with a toy

Exclusion Criteria:

  • history of periferal neurological lesion such as plexus brachialis lesion
  • presence of epilepsia, congenital brain malformation,
  • no informed consent
  • severe visual impairments
  • syndromal or genetical diseases resulting into developmental delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
full term infants
infants between 3-9 months old with gestational age more than 36 weeks
preterm infants
infants between 3-9 months old corrected age born with a gestational age less than 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fNIRS laterality index
Time Frame: Baseline
Difference in brain activitity over the sensorimotor cortex between left and right hemisphere during bilateral grasping. Averaged brain activity of the 10 blocks of bimanual grasping.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fNIRS bimanual activity
Time Frame: baseline
Averaged brain activity during the 10 blocks of bimanual reach-to-grasp movements.
baseline
fNIRS unmanual left-sided activity
Time Frame: baseline
Averaged brain activity during the 10 blocks of unilateral left-sided reach-to-grasp movements.
baseline
Hand assessment for Infants (HAI)
Time Frame: baseline

An assessment of hand function. It has been developed for infants at risk of developing cerebral palsy (CP) in the age range of 3-12 months. The HAI intends to measure the degree and quality of goal directed actions performed with each hand separately as well as with both hands together.

Items are scored based on a video-taped play session eliciting upper limb activity.

It results in three scales

  1. both hand measure: a criterian referenced overall measure of hand function based on all 17 items total raw score ranges ; 0-58 HAI-unit scale: 0-100 Higher score indicates better ability
  2. each hand sum score: a unimanual criterion referenced subscale based on 12 out of 17 items, score rated for each hand seperatly raw score ranges: 0-24 higher score indicates better ability
  3. percentage of difference between hands : percent calculated by the differences in left and right each hand sum score higer value indicate bigger difference between hands

age norm references available

baseline
Hammersmith infant neurological examination (HINE)
Time Frame: baseline

Hammersmith infant neurological examniation is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP).

26 items scoring 0-3 total score : 0-78 Higher score indicates more optimal developement normative data for age-matched, typically developing infants helps determine if the score is optimal or suboptimal.

baseline
fNIRS resting state functional connectivity
Time Frame: baseline
Functional connectivity within the sensorimotor cortex during a 5-7minutes of rest.
baseline
fNIRS unmanual right-sided activity
Time Frame: baseline
Averaged brain activity during the 10 blocks of unilateral right-sided reach-to-grasp movements.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nele De Bruyn, Phd, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It concerns personal data. There must first be investigated to which extent this data can be pseunominized for sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Preterm and Term Infants

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