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Obsessive-Compulsive DisorderNCT04086446

Transcranial Direct Current Stimulation (tDCS) in the Treatment of Drug-naïve Obsessive-compulsive Disorder(OCD)

A study testing high-definition transcranial direct current stimulation in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG). Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
high-definition transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteChina
Study dates
5 Nov 2019to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • age: 18-50 years old;
  • DSM-5 criteria for OCD;
  • Y-BOCS total score > or = 16, discontinued medication for at least 8 weeks before tDCS stimulation.
  • >or＝9 years education

Who cannot join

  • Any axis I psychiatric disorder comorbidity
  • The inability to receive tDCS because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery.
  • Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
  • Any current significant medical condition.
  • serious suicide risk

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Randomized Clinical Trial of Transcranial Direct Current Stimulation(tDCS) Treatment for Drug-naïve Obsessive-Compulsive Disorder(OCD)

This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG).

Read the detailed description

The purpose of this study is to examine the efficacy of tDCS over orbitofrontal cortex (OFC) in treatment of drug-naïve OCD patients. 60 drug-naïve OCD patients will be randomized into two groups (i.e. active or sham stimulation). tDCS stimulation will be performed once a day, five times a week, for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and TMS-EEG.

Being tested
high-definition transcranial direct current stimulation, Sham tDCS
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-definition transcranial direct current stimulationDevice

    The tDCS device will deliver a direct current of 1.5mA 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)

  • Sham tDCSDevice

    The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the first and last 15 seconds.

Study groups in NCT04086446
Study groupRoleWhat they receive
active tDCSActive comparatorCathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
Receives: Device: high-definition transcranial direct current stimulation
sham tDCSSham comparatorThe sham transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score

    It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

    Measured: Up to 3 months

Secondary outcomes (6)

  1. Change in Obsessive Compulsive Inventory-Revised(OCI-R)

    It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.

    Measured: Up to 3 months

  2. Change in Beck Depression Inventory(BDI)

    It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.

    Measured: Up to 3 months

  3. Change in Beck Anxiety Inventory (BAI)

    It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

    Measured: Up to 3 months

  4. Change in Perceived Stress Scale(PSS)

    It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.

    Measured: Up to 3 months

  5. Change in Pittsburgh sleep quality index(PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

    Measured: Up to 3 months

  6. Change in Side-effect questionnaire

    It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start5 Nov 2019
  3. Primary completion30 Aug 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086446
Sponsor's protocol ID
SMHC-OCD-004
Status last verified
May 2025
First submitted
8 Sep 2019
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Y, Cheng J, Li P, Jia W, Bai T, Lyu D, Yuan C, Jiang J, Wang Z. Electric field intensity and EEG microstate dynamics in obsessive-compulsive disorder: a secondary analysis of a randomized sham-controlled HD-tDCS trial. Eur Arch Psychiatry Clin Neurosci. 2026 May 14. doi: 10.1007/s00406-026-02238-6. Online ahead of print.

    PubMed 42133008

Questions about this trial

What is this clinical trial studying?

A study testing high-definition transcranial direct current stimulation in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04086446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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