New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder

Affective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596461
• Other study ID #: IIT20210036C-R1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hu ShaoHua, M.D
• Phone: 13357169115
• Email: dorhushaohua[@]zju.deu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 16-65 years old, regardless of gender;

2. Meet DSM-V diagnostic criteria for depression or bipolar disorder;

3. Duration of stable period = 3 months;

4. Young Mania Rating Scale (YMRS) = 6 points;

5. Hamilton Depression Rating Scale 17 - item (HDRS-17) score = 7;

6. The score of cognitive defects questionnaire (PDQ) = 17;

7. Han nationality, right-handed;

8. More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;

2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;

3. Those who do not cooperate or cannot effectively complete the experiment;

4. Drug, alcohol or other psychoactive substance abusers;

5. Pregnant, lactating or planned pregnancy.

Related Conditions & MeSH terms

• Affective Disorder
• Cognitive Dysfunction
• Mood Disorders

Intervention

Device:
• Transcranial magnetic stimulation
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.
• Transcranial direct current stimulation
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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