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

Not Applicable

Recruiting

• Conditions: Affective Disorder
• Interventions: Device: Transcranial direct current stimulation; Device: Transcranial magnetic stimulation

• Registration Number: NCT05596461
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-12-31
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial direct-current stimulation	Transcranial direct current stimulation	-
Transcranial magnetic stimulation	Transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
Wechsler Memory Scale	0-8 weeks	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China