Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder

NCT05563935 | Unknown

• 1 other identifier: 2021-51
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Case-control study; Repetitive transcranial magnetic stimulation; Decision-making confidence; Metabolism; Neural network; GABA

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.

  Change from Baseline at 6weeks

Secondary Outcomes (5)

• Hamilton Depression Scale (HAMD-17)

  Change from Baseline at 6weeks

• Hamilton Anxiety Scale (HAMA-14)

  Change from Baseline at 6weeks

• Florida Obsessive Compulsive Inventory (FOCI)

  Change from Baseline at 6weeks

• Obsessive Belief Questionnaire (OBQ-44)

  Change from Baseline at 6weeks

• State-Trait Anxiety Inventory (STAI)

  Change from Baseline at 6weeks

Other Outcomes (2)

• Decision-making confidence

  Change from Baseline at 6weeks

• The distribution and level of GABA in the brain

  Change from Baseline at 6weeks

Study Arms (2)

OCD group

ACTIVE COMPARATOR

OCD patients will receive rTMS treatment for 6 weeks.

Device: Repetitive transcranial magnetic stimulation

HC group

NO INTERVENTION

Health control will not receive any treatment.

Interventions

Repetitive transcranial magnetic stimulation DEVICE

The OCD group will receive rTMS treatment for 6 weeks. There are 5 rTMS treatments per week (Monday to Friday), and 30 rTMS treatments in total. Treatment is administered by Ma GPro X100 device (Maga Venture) with Cool-DB80 coil. Detailed parameters of rTMS: intensity of stimulus is 120% RMT; the frequency of trains is 1Hz and the number of pulses is 1; no intertrain intervals and the pulses number is 1000.

OCD group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• OCD group:
• Age between 18 and 50 years.
• Satisfied with the diagnostic criteria for OCD in DSM-V.
• Taking medication or unmedication stably for 8 weeks or drug-naive.
• YBOCS score ≥16.
• Education level was limited to above middle school.
• Has sufficient audiovisual skills to complete the necessary examinations for the study.
• Right-handed (this criterion is for fMRI subjects only).
• Subjects understood the study and signed informed consent.
• HC group:
• Match with the OCD group on age, gender, education years.
• Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
• No history of taking psychotropic drugs.
• No family genetic history of mental disorder.
• Has sufficient audiovisual skills to complete the necessary examinations for the study.

You may not qualify if:

• OCD group:
• Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
• HAMD-17 score ≥ 17.
• IQ \< 70.
• Obsessive-compulsive symptoms were too severe to participate in the experiment.
• Hoarding symptom.
• High risk of negative thought and suicide.
• Severe central system or physical disease or drug abuse.
• Pregnant women or women that getting ready for being pregnant and lactating.
• With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
• HC group:
• High risk of negative thought and suicide.
• HAMD-17 score ≥ 17.
• IQ \< 70.
• Severe central system or physical disease or drug abuse.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Qing Fan, Doctor

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Qihui Guo

CONTACT

15221398831; guoharry@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 3, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 3, 2022

Record last verified: 2021-09

Locations

CN (1)