GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)

Completed

• Conditions: Cortical Response; Pleasant Touch

• Registration Number: NCT03731195
• Lead Sponsor: University College Cork

Brief Summary

This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents, and effects will be assessed by monitoring brain responses (GentleTouch Project) in a prospective cohort study.

Detailed Description

This is a single-centre proof of concept translational study to determine how and when Somato-sensory evoked potentials develop over the first 4 months of life.

The aim of this study is to explore if the investigators can measure the cortical response from the scalp of infants using standard non-invasive EEG techniques, due to the activation of CT afferents and explore how the cortical response changes in regard to age. Preform a longitudinal study on 40 subjects at approximately 4 weeks and 4 months of age. The Gentle Touch study will examine the effect of gentle positive stimuli applied to an infant's forearm on cortical responses at two time points within the first 4 months of life.

Study Timeline

• Study Start: 2018-05-09
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Primary Completion: 2020-12-30
• Study Completion: 2021-07-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Infants born > 37 weeks gestation
• Single births
• Not requiring admission to the Neonatal Unit
• Healthy infants without suspected congenital or metabolic anomalies
• Written Informed Consent

Exclusion Criteria

• Infants born < 37 weeks gestation
• Multiple births
• Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
• Admission to the Neonatal Unit.
• No written Informed Consent obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement and development of SSEP response to positive touch stimuli	4 weeks	Standard Evoked Potentials

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental Assessment	4 months	Griffiths Mental Development Scales (GMDS)Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: * Foundations of Learning; * Language and Communication; * Eye and Hand Coordination; * Personal-Social-Emotional; * Gross Motor; Very Superior 16-20 Scaled Score \>130 Development Quotient Superior 14- \<16 Scaled Score 120 - 129 Development Quotient Above Average 12- \<14 Scaled Score 110 - 119 Development Quotient Average 8- \<12 Scaled Score 90 - 109 Development Quotient Below Average 6- \<8 Scaled Score 80 - 89 Development Quotient Borderline 4- \<6 Scaled Score 70 - 79 Development Quotient Extremely Low 0- \<4 Scaled Score ≤ 69 Development Quotient
Measurement of SSEP to positive touch stimuli	4 months	Standard Evoked Potentials

Trial Locations

Locations (2)

University College London - Institute of Child Health (UCL-ICH); 🇬🇧 London, United Kingdom

Cork University Maternity Hospital; 🇮🇪 Wilton, Cork, Ireland