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

Zhejiang University

Status: Enrolling

Conditions: Affective Disorder

Treatments: Device: Transcranial direct current stimulation; Device: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05596461

IIT20210036C-R1

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Transcranial magnetic stimulation

Experimental group

Treatment:

Device: Transcranial magnetic stimulation

Transcranial direct-current stimulation

Experimental group

Treatment:

Device: Transcranial direct current stimulation