Skip to content

Exploratory Study of Noninvasive Hypothermia Stimulation for the Treatment of Mild Cognitive Impairment in the Elderly

Exploratory Study of Dorsolateral Prefrontal Hypothermia Stimulation for the Treatment of Mild Cognitive Impairment in the Elderly (Sub-study of "Establishment of a program of application of multiple types of physical stimulation interventions to regulate different organismal functions")

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098266
Enrollment
Unknown
Registered
2025-03-05
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

mild cognitive impairment.

Interventions

hypothermia stimulation group:hypothermia stimulation
control group:Normal temperature stimulation

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Eligible participants are adults aged 65 to 80 years, inclusive of both sexes. 2. Patients, healthcare professionals, or informants report alterations in cognitive functions, including memory, that have persisted for a period of at least three months. (Documentation of progressive cognitive decline over time, as ascertained through medical records or clinical assessments) . 3. In accordance with the diagnostic criteria outlined in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), the individual does not fulfill the criteria for cognitive normality or dementia. However, the capacity for activities of daily living is within the normal range, as evidenced by a Mini-Mental State Examination (MMSE) score of >= 20 for individuals with primary education or >= 24 for those with junior education or higher, and a Montreal Cognitive Assessment (MoCA) score of <= 26, along with a Clinical Dementia Rating (CDR) of <= 1. 4. Have fully comprehended the details of the research protocol and signed the informed consents.

Exclusion criteria

Exclusion criteria: 1. Inability to understand the text, combined with a severe physical disability, or any other factor that may prevent completion of the neuropsychological assessment; 2. Any neoplastic disease (including polycythemia); 3. Clinically significant cardiovascular and cerebrovascular diseases, pulmonary diseases, liver diseases, kidney diseases, autoimmune or inflammatory diseases, metabolic and endocrine disorders, and severe neuropsychiatric diseases, such as AD, FTD, LBD, PD, schizophrenia, severe depression, epilepsy, etc.; 4. History of alcohol or drug abuse; Use of other drugs that may affect this study, such as sedatives, anti-anxiety drugs, hypnotics, nootropic drugs, cholinoid drugs; 5. Receive other acoustic, photoelectric and magnetic stimulation within a year; 6. Patients with Raynaud disease; 7. Cochlear implants, implanted electrodes, pacemakers or metal implants; 8. The assessment of daily living ability, mental state and social participation ability or sensory perception and communication ability indicates impaired function; 9. Life expectancy <1 year; 10. Poor compliance or inability to complete complete treatment; 11. The researcher believes that there are some circumstances that are inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
The changes of oxygen saturation of local brain tissue in the forehead;

Secondary

MeasureTime frame
Clinical cognitive function and symptom scores in each cognitive domain;Sleep status change;Clinical endpoint event;Local skin damage caused by hypothermic stimulation during treatment;body temperature changes;

Countries

China

Contacts

Public ContactHaiqing Song

Xuanwu Hospital Capital Medical University

songhq@xwhosp.org+86 13701390976

Outcome results

None listed

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