Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous
NEURONAUX
1 other identifier
observational
28
0 countries
N/A
Brief Summary
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedSeptember 19, 2018
September 1, 2018
6 months
September 14, 2018
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
specific temporal TTA-SW
The objective of this study is to evaluate the spatial organization of the specific Temporal theta slow-wave activity (TTA-SW) with the Low-Density Electroencephalography (LD-EEG) at an early stage of development in humans to demonstrate that TTA-SW were independent of auditory stimuli.
2 months
Study Arms (2)
13 high
High-Density ElectroEncephaloGraphy analysis of 13 healthy premature infants
15 low
Low-Density ElectroEncephaloGraphy analysis of other 15 healthy premature infants
Interventions
Eligibility Criteria
28 healthy premature infants follow-up between the Gestational Ages of 26 and 32 wGA between December 2014 and June 2015. These infants were divided into two groups accord- ing to age (26-30 wGA and 30-32 wGA).
You may qualify if:
- healthy premature infants
- Gestational Ages of 26 and 32 wGA
You may not qualify if:
- unhealthy premature infants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Wallois, MD, PhD
CHU AMIENS
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 19, 2018
Study Start
July 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
September 19, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share