- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880696
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates (PREMATEMP)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cathy GC Gaillard
- Phone Number: +33 02 31 06 53 49
- Email: gaillard-c@chu-caen.fr
Study Contact Backup
- Name: Bernard GB Guillois, MD
- Phone Number: +33 02.31.27.25.64
- Email: guillois-b@chu-caen.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Control (Random)
Random stimulation sequence & DCS
|
Near-infrared imaging of the neurovascular response in the left somatosensory cortex
Other Names:
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
Sponsor
Collaborators
Investigators
- Study Chair: Nadège RN Roche-Labarbe, PhD, Université Caen Normandie
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A01762-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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