Skip to content

Study on the regulatory mechanism of transcranial photobiomodulation on mild cognitive impairment

Study on the effects of transcranial neuromodulation on patients with brain dysfunction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101857
Enrollment
Unknown
Registered
2025-04-30
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Cognitive impairment, psychiatric disorders, Alzheimers disease, mild cognitive impairment

Interventions

Transcranial photobiomodulation intervention group:Transcranial photobiomodulation group: wavelength (1064nm), TTL frequency modulation controlled pulse mode, right dorsolateral prefrontal cortex, onc
Sham stimulation control group:Sham stimulation: Same as the experimental group mode, but the device emits sham stimulation.

Sponsors

Affiliated Hospital of Binzhou Medical College; National Research Center for Rehabilitation Technical Aids of the Ministry of Civil Affairs of the People's Republic of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Cognitive impairment inclusion criteria 1. Age >= 60 years, right-handed. 2. Meet the MCI diagnostic criteria (Petersen criteria: a. According to the patient or informant report, experienced clinicians found that the patient has cognitive impairment; b. The patient has objective evidence of impairment in one or more cognitive areas, among which episodic memory impairment is the most common; c. The patient's complex instrumental daily ability may be slightly impaired, but generally can maintain independent daily living ability; d. Has not yet reached the diagnostic criteria for dementia. 3. Subjective cognitive complaints (confirmed by family members/caregivers). 4. Objective cognitive impairment (MoCA Mandarin version =6 points). 5. Daily living ability is basically preserved (ADL <= 26 points). 6. HAMD-24 <= 7 points (excluding comorbid depression). 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for cognitive impairment 1. Other neurological diseases (stroke, brain tumor, epilepsy, etc.). 2. Severe physical illness (heart function grade III-IV, liver and kidney dysfunction, etc.). 3. Recent participation (within 6 months) in other intervention trials. 4. Contraindications to MRI (claustrophobia, metal implants, etc.).

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment (MoCA) original version v7.1 (Mandarin Chinese version);Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog);EEG power spectral density;Functional MRI—Default Network Connectivity Strength;

Secondary

MeasureTime frame
Metabolic indicators: serum lactate and ß-hydroxybutyrate concentrations;Task-state EEG index;Functional MRI - Changes in brain structure;Behavioral (cognitive paradigm) statistical scores;

Countries

China

Contacts

Public ContactLi Hongwei

Affiliated Hospital of Binzhou Medical College

drlihongwei@163.com+86 186 5439 7805

Outcome results

None listed

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