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Efficacy and Safety of Transcranial Photobiomodulation in Elderly with Mild Cognitive Impairment

Efficacy and Safety of Transcranial Photobiomodulation in Elderly with Mild Cognitive Impairment (The sub-project of “Establishing Application Protocols for Multi-Type Physical Stimulation Interventions Regulating Various Body Functions”)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098264
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 is defined by a Mini-Mental State Examination (MMSE) total score of =20 for individuals with primary education or =24 for those with junior education or higher, concomitant with a Montreal Cognitive Assessment (MoCA) total score of =26, and a Clinical Dementia Rating (CDR) of =1.

Interventions

808 group:Transcranial photobiomodulation
1064 group:Transcranial photobiomodulation
Control group:Sham stimulation

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 65-80 years old, regardless of gender; 2.The level of disability is categorized as Grade 0, indicating a preserved capacity for activities of daily living; 3.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); 4.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. 5.No severe active impairment in organ function; 6.Have fully comprehended the details of the research protocol and signed the informed consents;

Exclusion criteria

Exclusion criteria: 1.Ineligibility for participation is determined by an inability to understand the study materials, the presence of severe limb disabilities, or other factors that may impede the completion of a neuropsychological evaluation; 2.Any neoplastic disease (including polycythemia vera, excluding basal cell carcinoma or squamous cell carcinoma); 3.Presence of clinically significant cardiovascular and cerebrovascular diseases, pulmonary diseases, liver diseases, kidney diseases, autoimmune or inflammatory disorders, metabolic and endocrine disorders, as well as severe neuropsychiatric conditions such as Alzheimer's disease (AD), Frontotemporal dementia (FTD), Lewy body dementia (LBD), Parkinson's disease (PD), schizophrenia, major depressive disorder, epilepsy, and other serious mental illnesses; 4.History of alcohol or drug abuse; Use other drugs that may affect this study, such as sedatives, anti-anxiety drugs, hypnotics, educational drugs and cholinergic drugs; 5.Acute alterations in physiological functions, including incidents of falls, syncope, or delirium, occurring within a 30-day period; the presence of pressure-related injuries, such as decubitus ulcers, within the same timeframe; 6.Received electrical, magnetic, thermal, force and other physical stimulation; 7.Individuals with cochlear implants, implanted electrodes, cardiac pacemakers, or other metallic implants; 8.Assessments of activities of daily living, mental state, and social participation capabilities, as well as sensory and communication abilities, indicate functional impairment;

Design outcomes

Primary

MeasureTime frame
Neurobehavioral score;

Secondary

MeasureTime frame
Neuroelectrophysiological index;Neuroimaging index;Any adverse events;Neurobehavioral score;

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