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Not yet recruiting NCT07115615

Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder

No phase Interventional Obsessive Compulsive Disorder (OCD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high-definition transcranial direct current stimulation, Sham tDCS.
Who it may be relevant to
Registry conditions: Obsessive Compulsive Disorder (OCD). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder: A Randomized Controlled Trial Using High-resolution MRI

Overview

This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.

Detailed description

The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, electroencephalography (EEG).

Interventions

  • Device high-definition transcranial direct current stimulation
    The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)
  • Device Sham tDCS
    To demonstrate the same stimulation sensation as under real conditions, only 40 seconds of real stimulation (2mA) are given at the beginning of the treatment. In the remaining 20 minutes, only about 15ms of short current pulses of 110uA occur every 550ms.

Primary outcome measures

  • Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS) [Time frame: Up to 5 weeks]
Secondary outcome measures (3)
  • The Beck Depression Inventory-II(BDI-II) [Time frame: Up to 5 weeks]
  • The Beck Anxiety Inventory (BAI) [Time frame: Up to 5 weeks]
  • Side-effect questionnaire [Time frame: Up to 5 weeks]

Eligibility criteria

Inclusion criteria

  • Age 18-60 years old, Han ethnicity, right-handed
  • DSM-5 criteria for OCD;
  • Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation.
  • Years of education ≥9.

Exclusion criteria

  • Any axis I psychiatric disorder comorbidity
  • Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures.
  • Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS).
  • Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc.
  • History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery.
  • Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices.
  • Women who are pregnant or planning to become pregnant in the near future.
  • Serious suicide risks.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT07115615 · SMHC-YG-OCD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗