fNIRS Grasping Task in Infants

NCT07147673 | Recruiting

• 1 other identifier: ONZ-2022-0265
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm and Term Infants

Keywords

fNIRS; grasping; infants; preterm infants

Outcome Measures

Primary Outcomes (1)

• fNIRS laterality index

  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 Outcomes (6)

• fNIRS bimanual activity

  baseline

• fNIRS unmanual left-sided activity

  baseline

• Hand assessment for Infants (HAI)

  baseline

• Hammersmith infant neurological examination (HINE)

  baseline

• fNIRS resting state functional connectivity

  baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

hent University, vakgroep revalidatiewetenschappen

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nele De Bruyn, Phd

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele De Bruyn, Phd

CONTACT

00329 332 69 21; nele.debruyn@ugent.be

Christine Van den Broeck, prof. dr.

CONTACT

00329 332 69 21; christine.vandenbroeck@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: August 29, 2025
• Study Start: September 26, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

BE (1)