New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder
Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 10, 2023
March 1, 2023
2 years
May 26, 2022
March 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Wechsler Memory Scale
The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.
0-8 weeks
Study Arms (2)
Transcranial magnetic stimulation
EXPERIMENTALTranscranial direct-current stimulation
EXPERIMENTALInterventions
Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of cognitive impairment of affective disorder was left Dorsolateral prefrontal CORTEX (DLPFC) . The left lateral DLPFC and the primary visual Cortex (V1) both play important roles in cognitive process. The regions with the strongest functional connection between V1 and DLPFC were selected as the stimulation targets.
Targeted multi-channel tDCS based on individualized simulation scale can be combined with individualized simulation modeling optimization, and based on individual MRI information, through quantitative evaluation and intelligent algorithms to achieve stimulation parameter optimization, reduce the stimulation dose to non-target target areas, and improve target brain stimulation The treatment targeting and aggregation of the area can realize personalized and precise treatment.
Eligibility Criteria
You may qualify if:
- Age 16-65 years old, regardless of gender;
- Meet DSM-V diagnostic criteria for depression or bipolar disorder;
- Duration of stable period ≥ 3 months;
- Young Mania Rating Scale (YMRS) ≤ 6 points;
- Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
- The score of cognitive defects questionnaire (PDQ) ≥ 17;
- Han nationality, right-handed;
- More than 9 years of education.
You may not qualify if:
- History of severe somatic or brain organic diseases and craniocerebral trauma;
- Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
- Those who do not cooperate or cannot effectively complete the experiment;
- Drug, alcohol or other psychoactive substance abusers;
- Pregnant, lactating or planned pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
Zhou H, Wang M, Xu T, Zhang X, Zhao X, Tang L, Zhao P, Wang D, Lai J, Wang F, Zhang S, Hu S. Cognitive Remediation in Patients With Bipolar Disorder: A Randomized Trial by Sequential tDCS and Navigated rTMS Targeting the Primary Visual Cortex. CNS Neurosci Ther. 2024 Dec;30(12):e70179. doi: 10.1111/cns.70179.
PMID: 39703101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University
Study Record Dates
First Submitted
May 26, 2022
First Posted
October 27, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion
October 1, 2024
Last Updated
March 10, 2023
Record last verified: 2023-03