Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates (PREMATEMP)

August 23, 2016 updated by: University Hospital, Caen
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. They also allow us to establish harmonious social interactions, coordinating us with our interlocutor during an exchange. Our ability to form temporal expectations seems to emerge very early but the development of this process is unknown. We only know that a set of basic skills, probably related to that ability, are present from birth. This suggests that temporal processing capabilities emerge during the prenatal period, but this has not been studied. The objective of this project is to study preterm infants brain's ability to process the intervals between stimuli and to form expectations on that basis.

Study Overview

Detailed Description

40 patients (20 per group) : Presence of a functional response to stimulus omissions, only in the test group (regular presentation).

Group 1 will receive the test stimulation sequence (regular), Group 2 will receive the control stimulation sequence (random).

During the test sequence, a vibration will be repeated for 3 s interspersed with intervals of 5 s, creating an expectation about the presentation of the next stimulus. Every 8 to 12 vibrations (random), a vibration will be omitted. According to our hypothesis, we should observe an activity in the somatosensory cortex during the omission. A total of 10 omissions will be presented, bringing the total duration of stimulus presentation to 13 minutes.

During the control sequence, the interstimulus intervals are irregular, 3 to 7 seconds, so as not to induce expectations. Omissions in this case should not be associated with a functional brain response.

The presence of an activation in the primary somatosensory cortex will be assessed using Diffuse Correlation Spectroscopy (DCS), on newborns of 32, 33 and 35 weeks of corrected gestational age, during omissions in a regular vibrotactile stimulation sequence (test group) with respect to an irregular sequence (control group). A difference in activation during omissions between groups will reflect the presence of a processing of time intervals at the cortical level.

We will also assess the difference in amplitude and time to peak of the response between the corrected gestational ages and vigilance states.

Main endpoint: amplitude of the neurovascular response significantly higher and / or time to peak significantly shorter during the omissions in the test group (regular sequence) compared to the control group (irregular sequence), evaluated twice: at ages corrected SA 33 ± 3 days and 35 weeks ± 3 days , and if possible SA 32 ± 3 days (optional measure depending on the gestational age at birth and time to obtain consent).

Secondary endpoints: significant difference in amplitude and / or time to peak of the neurovasculat response between corrected gestational ages and vigilance states.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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

No older than 6 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 premature infants born to SA 31 + 0 days to 32 weeks + 6 days , hospitalized in the neonatal unit of the University Hospital of Caen

Exclusion Criteria:

  • Suspected neurological disorder (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia), or motor condition that might interfere with tactile perception on the hand
  • Intubation or CPAP
  • Viral of bacterial infection
  • Sedation at the time of measurement
  • Parent(s) who are minor or unable to give free and informed consent
  • No consent from the parents
  • Non-inclusion request by the child's neonatologist

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test (Regular)
Regular stimulation sequence & DCS
Vibrotactile stimulation of the right hand with regular intervals and random omissions
Near-infrared imaging of the neurovascular response in the left somatosensory cortex
Other Names:
  • Diffuse correlation spectroscopy
Active Comparator: Control (Random)
Random stimulation sequence & DCS
Near-infrared imaging of the neurovascular response in the left somatosensory cortex
Other Names:
  • Diffuse correlation spectroscopy
Vibrotactile stimulation of the right hand with random intervals and random omissions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Activation of the primary somatosensory cortex during stimulation omissions
Time Frame: Between 32 and 35 week of corrected gestational age
Between 32 and 35 week of corrected gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in amplitude or time to peak of the response as a function of age
Time Frame: Between 32 and 35 week of corrected gestational age
Between 32 and 35 week of corrected gestational age
Change in amplitude or time to peak of the response with age as a function of vigilance state
Time Frame: Between 32 and 35 week of corrected gestational age
Between 32 and 35 week of corrected gestational age

Collaborators and Investigators

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

Investigators

  • Study Chair: Nadège RN Roche-Labarbe, PhD, Université Caen Normandie

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

September 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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