Obsessive-Compulsive SymptomPhase 1NCT05501132
Efficacy of Intensified Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder
A Phase 1 study testing transcranial direct current stimulation in people with Obsessive-Compulsive Symptom, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Symptom
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2020to 25 Feb 2022
- Phase
- Phase 1
- 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
- Diagnosis of Obsessive-compulsive Disorder by a psychiatrist and DSM-5-based behavioral checklist
- being 18-50 years old
- providing written informed consent
- If female, negative urine pregnancy test
- stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
Who cannot join
- smoker
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
- history of head injury
- presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcranial Direct Current Stimulation (tDCS) in Symptoms, Quality of Life, Cognitive Deficits and Brain Physiology of Patients With Obsessive-compulsive Disorder
This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.
- Conditions
- Obsessive-Compulsive Symptom
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS
Patients will receive 10 sessions of 20 minutes of either 1 mA, 2 mA or sham electrical stimulation on 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| tDCS group 1 | Experimental | In the first experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 1 mA electrical stimulation on 5 consecutive days with two sessions per day. Receives: Device: transcranial direct current stimulation |
| tDCS group 2 | Experimental | In the second experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 2 mA electrical stimulation on 5 consecutive days with two sessions per day. Receives: Device: transcranial direct current stimulation |
| Control group | Placebo comparator | In the placebo group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of sham electrical stimulation on 5 consecutive days with two sessions per day. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale
Score in the Yale-Brown Obsessive-Compulsive (Y-BOCS). Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Measured: up to 1 month after the intervention
Beck Anxiety Questionnaire (BAI)
Score in the Beck Anxiety Questionnaire (BAI). The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Measured: up to 1 month after the intervention
Response inhibition task 1
Performance in the response inhibition tasks (Flanker test)
Measured: up to 1 month after the intervention
Working memory task
Performance in the working memory task as an executive function task
Measured: up to 1 month after the intervention
Response inhibition task 2
Performance in the response inhibition tasks (Go/No-Go task)
Measured: up to 1 month after the intervention
Secondary outcomes (4)
Beck Depression Questionnaire (BDI-II)
Score in the Beck Depression Questionnaire (BDI-II). The BDI-II scores are classified as below:
Score of 1-10: These ups and downs are considered normal. Score of 11-16: Mild mood disturbance. Score of 17-20: Borderline clinical depression. Score of 21-30: Moderate depression. Score of 31-40: Severe depression. Score of 40+ Extreme depression.
Measured: up to 1 month after the intervention
Quality of Life Questionnaire (WHOQUL)
Score in the Quality of Life Questionnaire. It has 26 items and each item is rated on a 5-point scale with a higher score indicative of higher quality of life.
Measured: up to 1 month after the intervention
electroencephalogram (EEG) oscillatory power
Change in the EEG power in alpha, delta, theta and beta bands
Measured: up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity
Change in the EEG functional connectivity
Measured: up to 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Aug 2020
- Primary completion1 Jun 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, Technical University of Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501132
- Sponsor's protocol ID
- IR.ARUMS.REC.1399.102
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alizadehgoradel J, Molaei B, Barzegar Jalali K, Pouresmali A, Sharifi K, Hallajian AH, Nejati V, Glinski B, Vicario CM, Nitsche MA, Salehinejad MA. Targeting the prefrontal-supplementary motor network in obsessive-compulsive disorder with intensified electrical stimulation in two dosages: a randomized, controlled trial. Transl Psychiatry. 2024 Feb 5;14(1):78. doi: 10.1038/s41398-024-02736-y.
PubMed 38316750
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcranial Direct Current Stimulation (tDCS) in Symptoms, Quality of Life, Cognitive Deficits and Brain Physiology of Patients With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT05501132
- Acronym / sponsor ID
- IR.ARUMS.REC.1399.102
- Conditions
- Obsessive-Compulsive Symptom
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS group 1 | Experimental | Device: transcranial direct current stimulationIn the first experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 1 mA electrical stimulation on 5 consecutive days with two sessions per day. |
| tDCS group 2 | Experimental | Device: transcranial direct current stimulationIn the second experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 2 mA electrical stimulation on 5 consecutive days with two sessions per day. |
| Control group | Placebo comparator | Device: transcranial direct current stimulationIn the placebo group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of sham electrical stimulation on 5 consecutive days with two sessions per day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Obsessive-compulsive Disorder by a psychiatrist and DSM-5-based behavioral checklist
- being 18-50 years old
- providing written informed consent
- If female, negative urine pregnancy test
- stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
Key exclusion criteria (7 listed)
- smoker
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAlso: tDCSPatients will receive 10 sessions of 20 minutes of either 1 mA, 2 mA or sham electrical stimulation on 5 consecutive days | Device | Control group, tDCS group 1, tDCS group 2 |
Primary outcome
Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale
Time frame: up to 1 month after the intervention
Score in the Yale-Brown Obsessive-Compulsive (Y-BOCS). Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Beck Anxiety Questionnaire (BAI)
Time frame: up to 1 month after the intervention
Score in the Beck Anxiety Questionnaire (BAI). The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Response inhibition task 1
Time frame: up to 1 month after the intervention
Performance in the response inhibition tasks (Flanker test)
Working memory task
Time frame: up to 1 month after the intervention
Performance in the working memory task as an executive function task
Response inhibition task 2
Time frame: up to 1 month after the intervention
Performance in the response inhibition tasks (Go/No-Go task)
4 secondary outcomes
Beck Depression Questionnaire (BDI-II)
Time frame: up to 1 month after the intervention
Quality of Life Questionnaire (WHOQUL)
Time frame: up to 1 month after the intervention
electroencephalogram (EEG) oscillatory power
Time frame: up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity
Time frame: up to 1 month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 38316750Alizadehgoradel J, Molaei B, Barzegar Jalali K, Pouresmali A, Sharifi K, Hallajian AH, Nejati V, Glinski B, Vicario CM, Nitsche MA, Salehinejad MA. Targeting the prefrontal-supplementary motor network in obsessive-compulsive disorder with intensified electrical stimulation in two dosages: a randomized, controlled trial. Transl Psychiatry. 2024 Feb 5;14(1):78. doi: 10.1038/s41398-024-02736-y.
- Published resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transcranial direct current stimulation in people with Obsessive-Compulsive Symptom, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
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 5 inclusion and 7 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 17 Mar 2026. 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 Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale (time frame: up to 1 month after the intervention). The study lists 5 primary outcomes in all. 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 NCT05501132, 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 17 Mar 2026.