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Effects of Transcutaneous Vagus Nerve Stimulation on Spatiotemporal Distribution of Cerebral Blood Flow and Cognitive Level During Hemodialysis: A Pilot Study

Effects of Transcutaneous Vagus Nerve Stimulation on Spatiotemporal Distribution of Cerebral Blood Flow and Cognitive Level During Hemodialysis: A Pilot Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082917
Enrollment
Unknown
Registered
2024-04-10
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patient with maintenance hemodialysis

Interventions

Treatment Group:Transaural Vagus Nerve Stimulation (taVNS) is performed 30 minutes after the initiation of hemodialysis in MHD patients, with each session lasting for 20 minutes.

Sponsors

Department of Rehabilitation Medicine, Sir Run Run Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Criteria for Maintenance Hemodialysis (MHD): 1. Age = 18 years; 2. Have been on maintenance hemodialysis for = 3 months, and be in a relatively stable condition; 3. No significant cognitive impairments or severe neurological diseases that may affect the study outcomes; 4. Capable of cooperating with multiple near-infrared brain function imaging collections and cognitive assessments before, during, and one hour after the start of hemodialysis; 5. Capable of cooperating with Vagus Nerve Stimulation (VNS) treatment; 6. Able to understand the purpose of the study, cooperate with the research process, and sign an informed consent form. Criteria for Healthy Subjects: 1. Age = 18 years; 2. No significant cognitive impairments or severe neurological diseases that may affect the study outcomes; 3. Capable of cooperating with near-infrared brain function imaging collections and cognitive assessments; 4. Capable of cooperating with Vagus Nerve Stimulation (VNS) treatment; 5. Able to understand the purpose of the study, cooperate with the research process, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Significant psychiatric and emotional abnormalities, or a history of neurological or psychiatric diseases; 2. History of epilepsy or convulsions; 3. Severe dementia or language barriers that prevent cooperation in completing scale assessments; 4. Concurrent neurological or musculoskeletal system diseases that affect cognitive function; 5. History of angina, myocardial infarction, or heart surgery within the past year; 6. Progressively worsening medical condition.

Design outcomes

Primary

MeasureTime frame
Task-related HbO2 concentration changes (changes in cerebral blood flow).;Resting-state functional connectivity strength.;Heart rate variability;

Secondary

MeasureTime frame
MoCA;CASP;N-Back paradigm reaction time and accuracy;

Countries

China

Contacts

Public ContactZhongli Jiang

Department of Rehabilitation Medicine, Sir Run Run Hospital, Nanjing Medical University

jiangzhongli@njmu.edu.cn+86 138 5189 8370

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026