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A Multicenter Randomized Controlled Trial of Transcranial Direct Current Stimulation Combined with Digital Therapeutics in Improving Mild Cognitive Impairment in the elderly

A Multicenter Randomized Controlled Trial of Transcranial Direct Current Stimulation Combined with Digital Therapeutics in Improving Mild Cognitive Impairment in the elderly

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106900
Enrollment
Unknown
Registered
2025-07-31
Start date
2026-06-19
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Mild Cognitive Impairment

Interventions

tDCS-only group (Group A): tDCS-only group (Group A):tDCS was administered by a professionally trained therapist. 1. Standardized tDCS Stimulation Protocol: (1) Current Parameters: 1) Stimulation in
weekly remote calibration (electrode impedance =4), seizure, or severe skin reaction
emergency response cards were provided with each device.
Sham tDCS combined with CDT group (Group B):Sham-tDCS combined with CDT (Group B): Sham-tDCS combined with CDT was administered by a professionally trained therapist. 1. Standardized tDCS Stimulation

Sponsors

The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. MCI patients who meet the diagnostic criteria of the 2010 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment; 2. Age 60-80 years old; 3. Voluntarily accept interviews and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Have other medical diseases that are advanced, severe, or unstable, 2. Patients with neurological diseases that affect brain dysfunction or impairment in the evaluation of cognitive function, and the medication/intervention regimen is unstable (drugs that have been used stably for >= 3 months can be included as appropriate, and specific drugs and dosages need to be recorded), 3. Have a history and symptoms of traumatic brain injury, or a history of taking other special drugs that may affect cognitive function (such as cholinesterase inhibitors, benzodiazepines, antipsychotics or antiepileptic drugs), or receive other cognitive interventions (such as acupuncture, repetitive transcranial magnetic stimulation, etc.); 4. Seriously ill and unable to be interviewed; 5. History of acute cerebrovascular disease within 3 months; 6. Diagnosed dementia; 7. Patients with epilepsy; 8. Brain tumor, meningitis, cerebrovascular accident in the acute stage; 9. Those with intracranial implants; 10. Patients with recent craniocerebral injury or maxillofacial trauma are prohibited, especially with additional anterior injuries; 11. Those with implantable pacemakers or defibrillators are prohibited; 12. Pregnant women are prohibited; 13. Those who have metal implants in their bodies; Metal materials (including magnetic resonance compatible materials such as titanium), arterial clips, etc.; 14. Visual and hearing impairment cannot cooperate with the completion of the intervention program. 15.The researchers consider any condition that may harm the participant or prevent them from meeting or fulfilling the study requirements.

Design outcomes

Primary

MeasureTime frame
Montreal cognitive ;Non-cognitive function emotions;

Secondary

MeasureTime frame
Working memory;Attention;Executive function;Neuropsychiatric Symptoms ;Anxiety;Depression;Sleep;Activity of daily living;Frail;Death anxiety;Heart rate variability;Electroencephalogram frequency;Blood oxygenation level dependent;Adherence;

Countries

China

Contacts

Public ContactGuo Haiyan

The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University

guohaiyan@sysush.com+86 137 6097 1228

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026