Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04527302
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)
Sponsor:
Shanghai Mental Health Center
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Direct Current Stimulation (tDCS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed Description:
The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT（ERP）combined with tDCS over the prefrontal cortex (mPFC) in treatment of OCD patients. 60 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into two groups (i.e. ERP+active tDCS or ERP+sham tDCS stimulation). Over a two-month period, all patients are received 10 sessions of individual CBT, including 8 sessions of concurrent tDCS with ERP (tDCS+ERP). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive MRI scan and EEG.
The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.
The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: