Cognitive impairment
Conditions
Interventions
Trial group:Transcutaneous Auricular Vagus Nerve Stimulation plus Nerve Block plus Pharmacotherapy
Control group:Transcutaneous Auricular Vagus Nerve Sham Stimulation Combined with Nerve Block and Pharmacotherapy
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Elderly: Age >= 60 years; 2. Neuropathic pain: Diagnosis of neuropathic pain according to the current International Association for the Study of Pain (IASP) criteria, with an ID Pain scale score >= 2 points; 3. Chronic pain: Pain in one or more locations (NRS >= 4 points) lasting > 1 month or recurring > 3 months; 4. Cognitive impairment without significant impairment in daily activities: Mini-Mental State Examination (MMSE) score <= 26 points & Functional Activities Questionnaire (FAQ) score < 9 points.
Exclusion criteria
Exclusion criteria: 1. Taking psychotropic drugs or medications that significantly impair cognitive function within the past one month; 2. History of allergy to analgesics or history of analgesic abuse and addiction; 3. Presence of organic diseases affecting cerebral function (e.g., Parkinson’s disease, epilepsy) or a history of cerebral infarction within the past year; 4. History of craniotomy; 5. Accompanied by cancer-related pain; 6. Severe cardiovascular disease (left ventricular ejection fraction, LVEF < 30%); 7. Severe hepatic dysfunction (Child-Pugh Class C); 8. Severe renal insufficiency (preoperative dialysis); 9. Severe anemia or coagulation disorders; 10. Acute infection or damage on the skin of the stimulated area; 11. Having metal or electronic implants in the body; 12. BMI less than 18 kg/m^2 or greater than 30 kg/m^2; 13. The patient requests to withdraw from the trial; 14. The patient is unable to understand or cooperate to complete the relevant scales; 15. The patient participates in other clinical trials concurrently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination Score at 12 Weeks Post-Intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination Score at Baseline and 1, 4, and 8 Weeks Post-Intervention;Numerical Rating Scale Score at Baseline and 1, 4, 8, and 12 Weeks Post-Intervention;Generalized Anxiety Disorder Scale Score at Baseline and 1, 4, 8, and 12 Weeks Post-Intervention;Patient Health Questionnaire-9 Score at Baseline and 1, 4, 8, and 12 Weeks Post-Intervention;Pittsburgh Sleep Quality Index Score at Baseline and 1, 4, 8, and 12 Weeks Post-Intervention;Incidence of Adverse Events During Intervention Period (e.g., pain at stimulation site, skin erythema, burning sensation, pruritus, nausea, etc.); | — |
Countries
China
Contacts
Public ContactShen Wen
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed