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Efficacy and mechanism of transcranial near-infrared light combined with transcranial direct current stimulation in the treatment of AD

Efficacy and mechanism of transcranial near-infrared light combined with transcranial direct current stimulation in the treatment of AD

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110487
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-08-07
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Alzheimers disease

Interventions

tNIRS+tDCS group:Transcranial near-infrared stimulation (tNIRS) parameters: Stimulation parameters: the wavelength was 1064nm near infrared light, the energy density was 208J/cm2, the stimulation int
The neuronavigation system was used to accurately determine the stimulation target. Stimulation duration: bilateral simultaneous 20 minutes, lasting 6W. Transcranial direct current stimulation (tDCS)
Stimulation targets: the anode was placed in the bilateral angular gyrus (P3, P4, international electroencephalogram 10/20 lead system), and the cathode was placed in the contralateral posterior ear m
Shame group:Using a machine that was consistent in appearance and operation with the real one, current appeared only at the beginning and the last 15 seconds of stimulation during sham stimulation. Du

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Subjects with informed consent; (2) Right-handed, aged 50-80 years, male or female; (3) Meeting the core clinical criteria of probable AD dementia in the 2011 NIA-AA revised diagnostic criteria for AD; (4) CDR <=2, 11<= MMSE <=26; (5) Positive results of plasma biomarker pTau217 (single molecule array assay, Udi Biotechnology Co., LTD.).

Exclusion criteria

Exclusion criteria: (1) Complicated with other neurological or mental disorders or serious diseases of other systems such as heart, liver, lung and kidney; (2) There were contraindications to MRI examination; (3) Benzodiazepines users or drug abuse history; (4) Severe aphasia or physical disability, unable to complete the neuropsychological examination; (5) Patients who cannot tolerate near-infrared light stimulation and transcranial electrical stimulation, such as allergic swelling, pain, etc.; (6) Brain magnetic resonance imaging showed significant focal lesions: more than 2 infarcts larger than 2cm in diameter, and infarcts in key areas such as thalamus, hippocampus, entorhinal cortex, parorhinal cortex, angular gyrus, cortex and other subcortical gray matter nuclei. White matter damage was grade 3 on the fazekas Scale. (7) Patients deemed unfit to participate in the trial by the investigators.

Design outcomes

Primary

MeasureTime frame
Alzheimer disease assessment scale-cog 13;

Secondary

MeasureTime frame
Mini-Mental State Examination;Montreal?Cognitive Assessment;Clinical dementia rating;Digit span test;Clock drawing task;Trail making test;Auditory Verbal Learning Test;Neuropsychiatric Inventory;Pittsburgh Sleep Quality Index;Hamilton Depression Scale;Blood AD inflammatory factors and metabolomics;Functional magnetic resonance imaging + pCASL;

Countries

China

Contacts

Public ContactMa Xiaowei

The First Hospital of Hebei Medical University

471398499@qq.com+86 186 3388 9096

Outcome results

None listed

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