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Safety and efficacy of Hf-tPCS in elderly patients with MCI and early dementia:A pilot study

Safety and efficacy of Hf-tPCS in elderly patients with MCI and early dementia:A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105302
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Mild Cognitive Impairment and early dementia

Interventions

t-PCS stimulates the 100 HZ group:100Hz transcranial pulse electrical stimulation
t-PCS stimulates the 400 HZ group:400Hz transcranial pulse electrical stimulation

Sponsors

Nanjing Drum Towel Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1.Age: 55-79 years old; 2.Educational level: junior high school or above; 3.Meets the diagnostic criteria for mild cognitive impairment/early dementia; 4.Right-handed; 5.No cerebrovascular disease; 6.No severe depression or anxiety; 7.No other neurological disorders that may lead to cognitive decline(such as brain tumors, Parkinson's disease, encephalitis, epilepsy, etc.); 8.No other diseases that may lead to cognitive decline (such as thyroid dysfunction, severe anemia, syphilis, AIDS, etc.); 9.No history of mental illness or congenital neurodevelopmental delay; 10.No history of severe traumatic brain injury; 11.No contraindications for magnetic resonance imaging (such as metal dentures, metal implants in the body, pacemakers, artificial heart valves, etc.); 12.No severe rhinitis, nasal polyps, nasopharyngeal carcinoma, or nasal surgery; 13.Severe organ dysfunction without active period; 14.The patient and their family members are informed and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.History of dementia or intellectual disability; 2.Use cognitive enhancers such as donepezil, cabaret, galantamine, and memantine; 3.Reversible medical conditions associated with potential cognitive impairment (e.g. history of vitamin B12 deficiency or hypothyroidism); 4.Diagnose current alcohol dependence or DSM-V disorders related to alcohol consumption; 5.Combining epilepsy or history of epilepsy; 6.There is a serious mental illness, such as schizophrenia and psychosis, or a family history of schizophrenia and psychosis; 7.There are clinically serious diseases involving cardiovascular, digestive, respiratory, endocrine, and central nervous systems; 8.History of cerebrovascular surgery; 9.History of cerebrovascular surgery; 10.Subjects with skull defects or severe scalp infections or inflammations at the site of stimulation. 11.Subjects with a history of craniotomy surgery, presence of any ferromagnetic metal or implanted medical devices in the head or body, such as cochlear implants, pacemakers or defibrillators, and a history of severe neurological disorders (such as brain tumors and intracranial infections); 12.Subjects with a history of benzodiazepine drugs, antipsychotic drugs, and antipsychotic drug dependence; 13.participants in other forms of non-invasive brain stimulation currently , including transcranial magnetic stimulation or transcranial direct current stimulation.

Design outcomes

Primary

MeasureTime frame
Moca score;

Secondary

MeasureTime frame
PSQI score;EEG;CDR score;p- tau181?p-tau-217?Aß42/40?p-tau181/ Aß42;Moca score;MRI-BOLD?MRT-DTI;RBANS score;

Countries

China

Contacts

Public ContactYang Li;Dai Wangshu

Nanjing Drum Towel Hospital

asdfghjklpoiu@194.com+86 25 8310 6666

Outcome results

None listed

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