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The effect of intermittent explosive theta stimulation on senile depression patients with mild cognitive impairment and the mechanism of brain function change

The effect of intermittent explosive theta stimulation on senile depression patients with mild cognitive impairment and the mechanism of brain function change

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080113
Enrollment
Unknown
Registered
2024-01-21
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Geriatric depression with mild cognitive impairment

Interventions

Intervention group:The treatment instrument is Rapid2 transcranial magnetic stimulator produced by British company Magstim. For reference, the left DLPFC was stimulated with pulses of 50Hz, which were
Pseudo-stimulus set:The coil was turned 90 degrees, with rubber separating the coil from the scalp. Other parameters were the same as in the iTBS group.

Sponsors

Beijing Anding Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Written informed consent signed by the patient; 2) Age =60 years old; 3) Meet the Diagnostic criteria for first or recurrent depression in the Diagnostic and Statistical Manual of Mental Disorders-fifth Edition (DSM-5); 4) Meet the diagnostic criteria of MCI International Working Group on mild cognitive impairment in 2003 5) Symptoms of Cognitive impairment, 12 points at baseline; Seven points 7) Primary school education or above.

Exclusion criteria

Exclusion criteria: 1) Those with suicidal thoughts or behaviors; 2) People with a history of epilepsy or coronary heart disease or other serious unstable physical diseases; 3) Previous or current DSM-5 diagnosis of the following psychiatric disorders: Organic mental disorders, Alzheimer's disease, secondary dementia from other causes, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder, undefined mental illness, patients with a history of substance abuse, including abuse of alcohol or active drugs in the past 12 months, other than nicotine; 4) Participate in another interventional clinical study within the past 1 month; 5) Severe aphasia, visual and hearing impairment, etc. could not complete the experimenter; 6) There are contraindications to iTBS, including: past or current seizures; Acute stage of brain organic diseases such as brain trauma, cerebral hemorrhage, cerebral infarction and intracranial infection; Intracranial metal and other foreign bodies; 7) Use of other cognitive-affecting drugs, including anticholinergics and psychotropic drugs, within the past 2 weeks 8) Unable to complete MRI; 9) MRI showed presence > 2 lacunar cerebral infarcts with volume > There were 1cm3 regional infarcts with significant white matter lesions, and the overall Fazekas score was 3.

Design outcomes

Primary

MeasureTime frame
3 Inter-group difference in the change from baseline in the total score of the Subject Scale (ADAS-Cog) between the two groups over the weekend;

Secondary

MeasureTime frame
At each follow-up point, the change values of HAMD-17, HAMA, DST, DSST, PSQI, MoCA and ADAS-cog scales of subjects in two groups compared with baseline;Functional magnetic resonance imaging (FMRI) showed different brain region connections between the two groups at baseline and 3 weekends;

Countries

China

Contacts

Public ContactQinge Zhang

Beijing Anding Hospital affiliated to Capital Medical University

zqe81@126.com+86 138 1159 1959

Outcome results

None listed

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