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

NCT ID: NCT05563935

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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OCD shows various abnormalities in cognitive function. Decision-making confidence is a burgeoning research focus on cognitive abnormality of OCD. Gamma-aminobutyric acid (GABA) is a type of inhibitory amino acid. Some studies have indicated that GABA shows metabolic abnormality in OCD.

Repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive treatment for OCD. This study intends to explore the differences of the function-metabolism coupling in decision-making confidence neural network between OCD and HC. And investigating the dynamic changes of the function-metabolism coupling after rTMS treatment (6 weeks) for OCD is another goal.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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OCD group

OCD patients will receive rTMS treatment for 6 weeks.

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type 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.

HC group

Health control will not receive any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Repetitive transcranial magnetic stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

OCD group:

1. Age between 18 and 50 years.
2. Satisfied with the diagnostic criteria for OCD in DSM-V.
3. Taking medication or unmedication stably for 8 weeks or drug-naive.
4. YBOCS score ≥16.
5. Education level was limited to above middle school.
6. Has sufficient audiovisual skills to complete the necessary examinations for the study.
7. Right-handed (this criterion is for fMRI subjects only).
8. Subjects understood the study and signed informed consent.

HC group:

1. Match with the OCD group on age, gender, education years.
2. Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
3. No history of taking psychotropic drugs.
4. No family genetic history of mental disorder.
5. Has sufficient audiovisual skills to complete the necessary examinations for the study.
6. Right-handed (this criterion is for fMRI subjects only).
7. Subjects understood the study and signed informed consent.

Exclusion Criteria

OCD group:

1. Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
2. HAMD-17 score ≥ 17.
3. IQ \< 70.
4. Obsessive-compulsive symptoms were too severe to participate in the experiment.
5. Hoarding symptom.
6. High risk of negative thought and suicide.
7. Severe central system or physical disease or drug abuse.
8. Pregnant women or women that getting ready for being pregnant and lactating.
9. 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:

1. High risk of negative thought and suicide.
2. HAMD-17 score ≥ 17.
3. IQ \< 70.
4. Severe central system or physical disease or drug abuse.
5. Pregnant women or women that getting ready for being pregnant and lactating.
6. 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qing Fan, Doctor

Role: STUDY_CHAIR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Qihui Guo

Role: CONTACT

15221398831

Other Identifiers

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2021-51

Identifier Type: -

Identifier Source: org_study_id

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