hent University, vakgroep revalidatiewetenschappen
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Location contact
Christine Van den Broeck, Prof
CONTACT
Nele De Bruyn, Phd
CONTACT
Nele De Bruyn, Phd
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07147673
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.
Interested in participating?
Request Info3 month–9 month
All sexes
Observational
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Christine Van den Broeck, Prof
CONTACT
Nele De Bruyn, Phd
CONTACT
Nele De Bruyn, Phd
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline
Averaged brain activity during the 10 blocks of bimanual reach-to-grasp movements.
Time frame: baseline
Averaged brain activity during the 10 blocks of unilateral left-sided reach-to-grasp movements.
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
age norm references available
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.
Time frame: baseline
Functional connectivity within the sensorimotor cortex during a 5-7minutes of rest.
Time frame: baseline
Averaged brain activity during the 10 blocks of unilateral right-sided reach-to-grasp movements.
Contact information is provided by the study sponsor or research team.
Christine Van den Broeck, prof. dr.
CONTACT
Nele De Bruyn, Phd
CONTACT
University Ghent
Other
Brain Function During Grasping Task in Three to Nine Months Infants Using fNIRS , the Difference Between Full and Preterm Born Infants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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