Efficacy and Mechanism of Augmentation of Cognitive Behavioral Therapy With Transcranial Alternating Current Stimulation(tACS) for Obsessive-Compulsive Disorder (OCD)
NCT ID: NCT06717165
Last Updated: 2025-08-01
Study Results
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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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-04-15
2027-12-31
Brief Summary
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Detailed Description
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The treatment program consists of a total of 10 sessions, with the first and last sessions being psychological therapy only. The middle eight sessions will involve concurrent transcranial alternating current stimulation (tACS) and exposure and response prevention (ERP). The timing of assessments is designed to capture changes in symptom severity during the intervals between consecutive combined treatment sessions.
Three independent evaluators will assess the severity of patients' obsessive-compulsive symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at four time points:
Baseline assessment (prior to the start of treatment); After the first combined session (Session 2) and before the second combined session (Session 3); After the fourth combined session (Session 5) and before the fifth combined session(Session 6); After the eighth combined session (Session 9) and before the final treatment session (Session 10).
Patients will also undergo electroencephalography (EEG) assessments at each evaluation time point. The current study aims to explore whether the administration of individualized stimulation frequency tACS in conjunction with ERP can enhance the efficacy of ERP, providing early evidence for revealing the potential neural mechanisms underlying this treatment. Additionally, participants will undergo magnetic resonance imaging (MRI) scans at treatment baseline and after the completion of the full course of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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active tACS+exposure based CBT
The exposure and response prevention (ERP) treatment concurrently with an anode transcranial alternating current stimulation over the mPFC will be applied 8 times (tACS+ERP, 8 sessions) in the whole treatment.
ERP combined with high-definition active tACS
The active tACS +ERP referred to a period of tACS applied in the first 20 minutes of the ERP treatment (the tACS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tACS+ERP treatment. Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). Anode electrode will be localized in front of the mPFC on the Fz point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AFz, Fcz, F1, F2).
sham tACS +exposure based CBT
the exposure and response prevention (ERP) treatment concurrently with an sham transcranial alternating current stimulation over the mPFC will be applied 8 times (sham tACS+ERP, 8 sessions) in the whole treatment.
ERP combined with sham tACS
Patients will get the same CBT setting as the active tACS group and they were applied the sham tACS cocurrently with ERP. The sham tACS device is the same as the active comparator's except that the sham tACS will only deliver a current stimulation for the first and last 15 seconds in order to produce somatic sensation in patients similar to that induced by the active tACS.
Interventions
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ERP combined with high-definition active tACS
The active tACS +ERP referred to a period of tACS applied in the first 20 minutes of the ERP treatment (the tACS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tACS+ERP treatment. Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). Anode electrode will be localized in front of the mPFC on the Fz point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AFz, Fcz, F1, F2).
ERP combined with sham tACS
Patients will get the same CBT setting as the active tACS group and they were applied the sham tACS cocurrently with ERP. The sham tACS device is the same as the active comparator's except that the sham tACS will only deliver a current stimulation for the first and last 15 seconds in order to produce somatic sensation in patients similar to that induced by the active tACS.
Eligibility Criteria
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Inclusion Criteria
* With at least 9 years of education
* Y-BOCS score ≥16
* No history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary)
* Medication-free or had received stable medication for at least 8 weeks before entering the study and continued the same medication throughout the study
Exclusion Criteria
* OCD symptoms are severe, preventing the patient from completing the required assessment and examination
* Serious suicide risk
* Women who are pregnant or planning to become pregnant
* Currently taking antiepileptic medication
* Clinically significant physical illnesses or laboratory test abnormalities that have clinical significance
* Previous completion of a full course of CBT/ERP treatment
18 Years
60 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Zhen Wang
vice-president
Principal Investigators
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Zhen Wang, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SMHC-OCD-013
Identifier Type: -
Identifier Source: org_study_id
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