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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qihui Guo; Phone Number: 15221398831; Email: guoharry@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCD group; OCD patients will receive rTMS treatment for 6 weeks.	Device: 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.
No Intervention: HC group; Health control will not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale (HAMD-17)	It is one of the most widely used examiner-rating depression scales, which contains 17 items. It is used to measure the severity of depression and its change in treatment. The total score range is 0-59, and a lower score means a better outcome.	Change from Baseline at 6weeks
Hamilton Anxiety Scale (HAMA-14)	It is one of the most widely used examiner-rating anxiety scales, which contains 14 items. It is used to measure the severity of anxiety and its change in treatment. The scoring method adopts a five-point scale of 0-4 points. The total score range is 0-56 and a lower score means a better outcome.	Change from Baseline at 6weeks
Florida Obsessive Compulsive Inventory (FOCI)	FOCI, a self-rating scale, is used to assess the severity of obsessive-compulsive symptoms within one month, which contains 20 items. The first 15 items are evaluated the symptoms by yes and no, and the last 5 items are evaluated the severity of symptoms on 0-4 five-point scale. The total score range is 0-20 and a lower score means a better outcome.	Change from Baseline at 6weeks
Obsessive Belief Questionnaire (OBQ-44)	It is a self-rating scale to assess the severity of the obsessive belief, which contains 44 items. The scoring method adopts a seven-point scale of 1-7 points. The total score range is 44-308 and a lower score means a better outcome.	Change from Baseline at 6weeks
State-Trait Anxiety Inventory (STAI)	It is one of the most widely used self-rating anxiety scales, which contains 40 items. The first 20 items are used to measure the state anxiety and the last 20 items are used to measure trait anxiety. The scoring method adopts a four-point scale of 1-4 points. Both the total score range of state anxiety and trait anxiety are 20-80 and a lower score means a better outcome.	Change from Baseline at 6weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision-making confidence	The decision-making confidence is measure by randomized dot motion (RDM) task with a self-reported confidence scale (1-4 points). And a lower score means a lower decision-making confidence.	Change from Baseline at 6weeks
The distribution and level of GABA in the brain	Using the SPICE (an advanced MRI technology) to measure the distribution and level of gamma-aminobutyric acid (GABA) in the brain. The change of GABA metabolism will be observed during treatment.	Change from Baseline at 6weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: Qing Fan, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Repetitive transcranial magnetic stimulation; Obsessive-Compulsive Disorder; Metabolism; GABA; Neural network; Case-control study; Decision-making confidence
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2021-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No