Study of the Brain's Natural Cleaning System in Potential Organ Donors.
ConditionAnatomical Description
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGermans Trias i Pujol Hospital
About this trial
Alzheimer's disease is a condition that affects the brain and is associated with the build-up of waste substances that can damage brain cells. Scientists have recently discovered a natural drainage and cleaning system around the brain, called the meningeal lymphatic system, which may help remove these waste products.
Researchers believe that this brain drainage system is connected to lymph nodes located in the neck. However, this connection has not yet been clearly demonstrated in humans because it is difficult to study.
The purpose of this study is to investigate how fluid drains from the brain to the lymph nodes in the neck. To do this, researchers will use a fluorescent dye called indocyanine green, which can be seen with a special camera. The study will be carried out in potential organ donors who have been authorized for organ donation.
The researchers will record images and videos to observe how the dye moves, how long it takes to reach the lymph nodes, whether the drainage is similar on both sides of the body, and which lymph nodes are involved.
A better understanding of these drainage pathways may help researchers develop and improve future treatments for Alzheimer's disease and other neurological disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Potential organ donor patients, both in Brain Death and in Controlled Asystole, candidates to perform organ harvesting authorized by the Transplant and Tissue Coordination of the Universitary Germans Trias i Pujols Hospital, according to the usual channels and whose family members have previously signed the authorization of the donation and the specific informed consent of the study. Will be included in the study always after death is certified by neurological or cardiocirculatory criteria
Disqualifiers
Absence of informed consent signed by family members.
Individuals with a history of having intracranial lymphatic drainage affected.
Trial design
Design model
Single group
Treatments tested in this trial
Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes
Procedure/SurgeryBicoronal incision and craniectomy will be performed to inject a small amount of indocyanin green into the meningeal space and evaluate migration with a fluorescence chamber. A small cervical lateral incision is added for flow monitoring and ends with the aesthetic closure of this. It will be completed with the aesthetic closure of the incisions, which can also be easily hidden.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Interventional single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
indocyanin green drainage pathway and distribution
Time frame
baseline2
Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.
The fluorescence camera will be used to take images and videos to assess whether flow drainage is present or absent
Time frame
baseline3
Cervical ganglion levels to which the ICG migrates.
cervical nodes receiving the migrated ICG anatomical level location
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov