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

Cortical Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731195
• Other study ID #: GB01/18UCC
• Status: Completed
• Start date: May 9, 2018
• Est. completion date: July 8, 2021

Study information

• Verified date: December 2023
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 8, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Cortical Response
• Pleasant Touch

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Wilton	Cork
United Kingdom	University College London - Institute of Child Health (UCL-ICH)	London

Sponsors (4)

Lead Sponsor	Collaborator
University College Cork	Johnson & Johnson, Science Foundation Ireland, University College London - Institute of Child Health (UCL-ICH)

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

References & Publications (7)

Lenehan SM, Fogarty L, O'Connor C, Mathieson S, Boylan GB. The Architecture of Early Childhood Sleep Over the First Two Years. Matern Child Health J. 2023 Feb;27(2):226-250. doi: 10.1007/s10995-022-03545-9. Epub 2022 Dec 31. — View Citation

O Sullivan MP, Livingstone V, Korotchikova I, Dempsey EM, Murray DM, Boylan GB. Reference centiles for infant sleep parameters from 4 to 16 weeks of age: findings from an Irish cohort. Arch Dis Child. 2023 Jun;108(6):481-485. doi: 10.1136/archdischild-202 — View Citation

Ventura S, Mathieson SR, O'Sullivan MP, O'Toole JM, Livingstone V, Pressler RM, Dempsey EM, Murray DM, Boylan GB. Parent-led massage and sleep EEG for term-born infants: A randomized controlled parallel-group study. Dev Med Child Neurol. 2023 Oct;65(10):1 — View Citation

Ventura S, Mathieson SR, O'Toole JM, Livingstone V, Ryan MA, Boylan GB. Electroencephalographic sleep macrostructure and sleep spindles in early infancy. Sleep. 2022 Jan 11;45(1):zsab262. doi: 10.1093/sleep/zsab262. — View Citation

Wei L, Ventura S, Lowery M, Ryan MA, Mathieson S, Boylan GB, Mooney C. Random Forest-based Algorithm for Sleep Spindle Detection in Infant EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:58-61. doi: 10.1109/EMBC44109.2020.9176339. — View Citation

Wei L, Ventura S, Mathieson S, Boylan G, Lowery M, Mooney C. Spindle-AI: Sleep Spindle Number and Duration Estimation in Infant EEG. IEEE Trans Biomed Eng. 2022 Jan;69(1):465-474. doi: 10.1109/TBME.2021.3097815. Epub 2021 Dec 23. — View Citation

Wei L, Ventura S, Ryan MA, Mathieson S, Boylan GB, Lowery M, Mooney C. Deep-spindle: An automated sleep spindle detection system for analysis of infant sleep spindles. Comput Biol Med. 2022 Nov;150:106096. doi: 10.1016/j.compbiomed.2022.106096. Epub 2022 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement and development of SSEP response to positive touch stimuli	Standard Evoked Potentials	4 weeks
Secondary	Measurement of SSEP to positive touch stimuli	Standard Evoked Potentials	4 months
Secondary	Neurodevelopmental Assessment	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	4 months