Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07682155

Study of the Brain's Natural Cleaning System in Potential Organ Donors.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anatomical Description Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Germans Trias i Pujol Universitary Hospital

Badalona, Barcelona, 08916, Spain

Location status: Recruiting

About this study

Design Prospective interventionist study: in which the flow of lymph fluid from the intracranial region to the deep cervical ganglia will be studied in the potential organ donor (PDO).

Study population Potential organ donor patients (PDO), both donors in Brain Death and Donors in Controlled Asystole, candidates to perform extraction thereof and authorized by the Transplant Coordination of the University Germans Trias i Pujol Hospital.

total number of subjects There will be 20 flow measurements, so if it is bilateral, there would be 10 potential donors.

Variables Images and videos will be obtained using the fluorescence camera. To be evaluated: time, direction, ganglion levels, symmetry. Data source Memory storage of the PDE (Hamamatsu, Photonics) fluorescence device. They will be collected in a database.

Medical history of the donor. Medicinal product or medical device under evaluation (where applicable) Not applicable Data analysis The images and videos collected will be evaluated, analyzing the variables in the different corpses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Absence of informed consent signed by family members.
  • Individuals with a history of having intracranial lymphatic drainage affected.

Treatment and study plan

Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes

Procedure

Bicoronal 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.

Primary outcomes

  1. presence or absence of bilateral and symmetrical distribution of indocyanin green drainage

    Time frame: baseline

    indocyanin green drainage pathway and distribution

  2. Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.

    Time frame: baseline

    The fluorescence camera will be used to take images and videos to assess whether flow drainage is present or absent

  3. Cervical ganglion levels to which the ICG migrates.

    Time frame: baseline

    cervical nodes receiving the migrated ICG anatomical level location

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Higueras, PhD

CONTACT

[email protected]

+34 934 65 12 00

Maria Del RIo, PhD

CONTACT

[email protected]

+34 934 65 12 00

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

Study of Drainage From the Cerebral Lymphatic System to Deep Cervical Nodes by the Migration of Indocyanine Green in Recent Cadaver

Acronym: ICGBRAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.