Pleasant TouchNCT03731195
GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
An observational study of Pleasant Touch and Cortical Response, run by University College Cork at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 37 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pleasant Touch, Cortical Response
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 May 2018to 8 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy Term infants >37 weeks Gestational Age
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
University College London - Institute of Child Health (UCL-ICH)
London, WC1N 1EH
About this study
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.
Read the 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.
- Conditions
- Pleasant Touch, Cortical Response
- Keywords
- Baby Massage, SSEP
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and development of SSEP response to positive touch stimuli
Standard Evoked Potentials
Measured: 4 weeks
Secondary outcomes (2)
Measurement of SSEP to positive touch stimuli
Standard Evoked Potentials
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start9 May 2018
- Primary completion30 Dec 2020
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pleasant TouchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- University College London - Institute of Child Health (UCL-ICH), Science Foundation Ireland, Johnson & Johnson
- Responsible party
- Principal investigator, Professor Geraldine Boylan, University College Cork
- Investigators
- Ronit Pressler, MD, Principal investigator, University College London - Institute of Child Health (UCL-ICH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731195
- Sponsor's protocol ID
- GB01/18UCC
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2018
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34755881Wei 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.
PubMed 34280088Wei 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 Sep 15.
PubMed 36162199Wei 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.
PubMed 33017930Lenehan 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.
PubMed 36586054O 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-2022-324016. Epub 2023 Mar 21.
PubMed 36944485Ventura 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):1395-1407. doi: 10.1111/dmcn.15565. Epub 2023 Mar 14.
PubMed 36917624
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
- ClinicalTrials.gov ID
- NCT03731195
- Acronym / sponsor ID
- GB01/18UCC
- Conditions
- Pleasant Touch, Cortical Response
- Keywords
- Baby Massage, SSEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University College London - Institute of Child Health (UCL-ICH), Science Foundation Ireland, Johnson & Johnson
- Study start
- 9 May 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy Term infants >37 weeks Gestational Age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement and development of SSEP response to positive touch stimuli
Time frame: 4 weeks
Standard Evoked Potentials
2 secondary outcomes
Measurement of SSEP to positive touch stimuli
Time frame: 4 months
Neurodevelopmental Assessment
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Results publication: PubMed 34755881Ventura 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.
- Results publication: PubMed 34280088Wei 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.
- Results publication: PubMed 36162199Wei 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 Sep 15.
- Results publication: PubMed 33017930Wei 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.
- Results publication: PubMed 36586054Lenehan 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.
- Results publication: PubMed 36944485O 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-2022-324016. Epub 2023 Mar 21.
- Results publication: PubMed 36917624Ventura 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):1395-1407. doi: 10.1111/dmcn.15565. Epub 2023 Mar 14.
- Individual participant dataSharing planned: No
Related trials for Pleasant Touch
Not yet recruitingObservational study
Pleasant Touch Perception in Persistent Pain.
Chronic Pain, Persistent Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronit Pressler, MD principal investigator
University College London - Institute of Child Health (UCL-ICH)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleasant Touch and Cortical Response, run by University College Cork at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and development of SSEP response to positive touch stimuli (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731195, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.