fNIRS Grasping Task in Infants

NCT ID: NCT07147673

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2027-09-30

Brief Summary

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.

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.

Conditions

Preterm and Term Infants

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

full term infants

infants between 3-9 months old with gestational age more than 36 weeks

No interventions assigned to this group

preterm infants

infants between 3-9 months old corrected age born with a gestational age less than 36 weeks

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nele De Bruyn, Phd

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

hent University, vakgroep revalidatiewetenschappen

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Nele De Bruyn, Phd

Role: CONTACT

nele.debruyn@ugent.be

00329 332 69 21

Christine Van den Broeck, prof. dr.

Role: CONTACT

christine.vandenbroeck@ugent.be

00329 332 69 21

Facility Contacts

Nele De Bruyn, Phd

Role: primary

nele.debruyn@ugent.be

0032 9 332 69 21

Christine Van den Broeck, Prof

Role: backup

christine.vandenbroeck@ugent.be

0032 9 332 69 21

Other Identifiers

ONZ-2022-0265

Identifier Type: -

Identifier Source: org_study_id