Effect of Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in Patients With Intracranial Lymphatic Circulation Disorder
Recruiting · NCT07328386 · Interventional (participants receive a specific treatment) · Lead sponsor: Hong Joonpio
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is a single-center, prospective clinical trial designed to evaluate the therapeutic effects of lymphaticovenular anastomosis (LVA) and lymph node-venous anastomosis (LNVA) in patients with intracranial lymphatic circulation disorders. Following voluntary written informed consent, screening assessments will be performed in accordance with the clinical trial protocol. Eligibility will be determined based on the predefined inclusion and exclusion criteria, and eligible subjects will be enrolled in the study. Enrolled participants will undergo cognitive function assessments at baseline (pre-surgery) and at 1, 3, 6, 9, 12, 18, and 24 months postoperatively for follow-up. Cognitive evaluations will not be additionally performed for research purposes but will be conducted in accordance with the existing clinical care schedule and standard treatment guidelines.
Who can take part
Inclusion criteria
- Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation.
- Global Deterioration Scale (GDS) score between 3 and 5 at screening.
- Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder.
- Able to provide written informed consent to participate in the study voluntarily.
Exclusion criteria
- Unable to undergo follow-up evaluation for at least 12 months after surgery.
- Diagnosed with vascular dementia.
- Presence of structural brain disease other than intracranial lymphatic circulation disorder.
- Known hypersensitivity to indocyanine green (ICG).
- Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders.
- History of previous neck surgery.
- Refusal to participate or failure to provide informed consent.
- Determined by the principal investigator to be unsuitable for participation due to any other clinical reason.
Where it is running
1 location listed.
- Asan Medical Center - Seoul, South Korea