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

December 4, 2023 updated by: Professor Geraldine Boylan, University College Cork
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Cork
      • Wilton, Cork, Ireland, T12 DC4A
        • Cork University Maternity Hospital
  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • University College London - Institute of Child Health (UCL-ICH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Term infants >37 weeks Gestational Age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement and development of SSEP response to positive touch stimuli
Time Frame: 4 weeks
Standard Evoked Potentials
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of SSEP to positive touch stimuli
Time Frame: 4 months
Standard Evoked Potentials
4 months
Neurodevelopmental Assessment
Time Frame: 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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

Johnson & Johnson
Science Foundation Ireland
University College London - Institute of Child Health (UCL-ICH)

Investigators

  • Principal Investigator: Ronit Pressler, MD, University College London - Institute of Child Health (UCL-ICH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GB01/18UCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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