Intracorporeal Nanocomposites and Neurological Disorders in Fulgurates (FulgurnanoF)
Fulgurnano
Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration
2 other identifiers
observational
27
1 country
5
Brief Summary
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects. Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance. The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.
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 May 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2020
CompletedSeptember 11, 2020
September 1, 2020
1.3 years
May 5, 2020
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Description of bioresistant nanocomposites
Characterization in blood
Day 0
Description of bioresistant nanocomposites
Characterization in blood
Month 24
Description of bioresistant nanocomposites
Characterization in urine
Hour 12
Description of bioresistant nanocomposites
Characterization in urine
Month 24
Secondary Outcomes (4)
neurological disorders
Day 0
neurological disorders
Month 24
neuropsychological disorders
Day 0
neuropsychological disorders
Month 24
Study Arms (2)
victims
thirteen patients affected by lightning in collective fulguration
healthy witnesses
fourteen healthy witnesses who have never been in contact with lightning, matched on age and sex
Interventions
Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses
Eligibility Criteria
patients affected by lightning in collective fulguration and healthy witnesses who have never been in contact with lightning, matched on age and sex
You may qualify if:
- Patients exposed: all subjects who were victims of the fulguration accident.
- Non-exposed patients:
- subjects,
- of all ages,
- free of major pathology and having never been the victim of a fulguration accident, nor having witnessed a fulguration at less than 20 meters,
- having never worked in a high-energy environment (CEA, EDF, particle accelerator, AREVA-type laboratory, radiology manipulator, radiation protection profession).
You may not qualify if:
- Pregnant or breastfeeding woman.
- Subject under guardianship, curatorship or safeguard of justice, or deprived of liberties.
- Any condition judged by the investigator to be incompatible with the research.
- Refusal to participate. Exposed patients: if the above-mentioned accident induced more than a simple lightning strike (lightning: died by lightning, electrocution: touched by an electric current, electrocution: died by contact with an electric current).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- PROMES UPR 8521 DR2-CNRScollaborator
- LPC UMR 6533, Campus Universitaire des Cézeauxcollaborator
Study Sites (5)
CH Henri Mondor
Aurillac, France
CH de Luneville
Lunéville, France
CHRU Bradois
Nancy, France
CHRU de Nancy
Nancy, France
CH de SAINT-DIE-DES-VOSGES
Saint-Dié, France
Biospecimen
Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Caumon
CH Henri Mondor (Aurillac)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 8, 2020
Study Start
May 20, 2019
Primary Completion
September 10, 2020
Study Completion
September 10, 2020
Last Updated
September 11, 2020
Record last verified: 2020-09