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The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation combined with Direct Current Stimulation (rTMS-tDCS) in Elderly Patients with Cognitive Impairment

Establishing Application Protocols for Multi-Type Physical Stimulation Interventions Regulating Various Body Functions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091931
Enrollment
Unknown
Registered
2024-11-06
Start date
2024-11-11
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

cognitive impairment

Interventions

Sham-stimulation group:Sham electromagnetic stimulation
Single-HFrTMS group:High frequency repetitive transcranial magnetic stimulation (HFrTMS)
Single-tDCS group:Transcranial direct current stimulation (tDCS)
rTMS-tDCS group:High frequency repetitive transcranial magnetic stimulation (HFrTMS) combined with transcranial direct current stimulation (tDCS)

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, gender is not limited; 2.Meet the diagnostic criteria of dementia or mild cognitive impairment (MCI) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, and the score of Clinical Dementia Rating Scale (CDR) is =0.5; 3.Not receiving physical stimulation treatment such as TES and TMS within 1 month before enrollment; 4.Not receiving relevant medication within 1 month before enrollment; if cognitive improvement medication has been taken, the medication must have been taken for =4 weeks, and there is no medication adjustment during the treatment period; 5.Right-handed; 6.A native speaker of Chinese; 7.Agreed to long-term follow-up, have a qualified informant, and be accompanied by the informant at each follow-up visit; 8.Understood all the contents of the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Inable to comprehend text, comorbid severe physical disability, or any other factor that may prevent completion of the neuropsychological evaluation; 2.Any neoplastic disease (including erythrocytosis, excluding basal cell carcinoma or squamous cell carcinoma); 3.Clinically significant cardiovascular, pulmonary, hepatic, renal, autoimmune or inflammatory diseases, metabolic and endocrine disorders, and severe neuropsychiatric disorders such as arrhythmias, epilepsy, FTD, LBD, PD, schizophrenia, and major depressive disorder; 4.History of alcohol or drug abuse; 5.Use of other medications that may affect this study, such as sedative-hypnotic medications, anti-anxiety medications, etc; 6.Rapid changes in body function such as falls, syncope, or delirium within 30 days; 7.Presence of pressure injuries (e.g., pressure sores, etc.) within 30 days; 8.There are cochlear implants, implanted electrodes, pacemakers, or metal implants; 9.Life expectancy < 6 months; 10.Participants in any other clinical trial within 1 month prior to baseline; 11.Refused to sign informed consent, poor compliance, or failure to cooperate with treatment, etc; 12.Other conditions that make participation in this study inappropriate.

Design outcomes

Primary

MeasureTime frame
Neuropsychological scores;

Secondary

MeasureTime frame
Neuroelectrophysiological index;Multimodal MRI of the head;Any adverse events;

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