Adult Attention Deficit Hyperactivity DisorderNCT07565402
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Adult Attention Deficit Hyperactivity Disorder, run by Nanjing Medical University at 1 site in China.
Trial summary
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined with Dialectical Behavior Therapy Skills Training in Adults with Attention-Deficit/Hyperactivity Disorder Abstract Adult attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that frequently persists into adulthood… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis confirmed using the Chinese version of the Diagnostic Interview for ADHD in Adults (DIVA-5).
- Aged between 18 and 55 years.
- Right-handed.
- Voluntary participation with provision of written informed consent.
Who cannot join
- Presence of neurological disorders or other psychiatric disorders.
- Severe physical illness.
- Receipt of electroconvulsive therapy (ECT) or other physical treatments within 6 months prior to enrollment.
- Planned changes in ADHD-related medication before the final follow-up assessment.
- Contraindications to tDCS (e.g., intracranial metal or electronic implants, skull plates, or other cranial implants).
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Chun Wang, PhD, 15850566376, wang_chun@nju.edu.cn
About this study
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined with Dialectical Behavior Therapy Skills Training in Adults with Attention-Deficit/Hyperactivity Disorder
Abstract Adult attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that frequently persists into adulthood and is associated with substantial impairments in academic, occupational, and social functioning. Although pharmacological treatment remains the primary intervention, some adults with ADHD show limited response to medication or experience adverse effects, highlighting the need for effective non-pharmacological or combined treatment approaches. Dialectical Behavior Therapy Skills Training (DBT-ST), which emphasizes emotion regulation, impulse control, mindfulness, and behavioral organization, has shown potential in the treatment of adult ADHD. However, its therapeutic efficacy may vary across individuals, and strategies to enhance treatment outcomes still require further investigation. In parallel, transcranial direct current stimulation (tDCS), a safe and non-invasive neuromodulation technique, has attracted increasing attention as an adjunctive intervention in psychiatric disorders. Existing studies suggest that combining tDCS with psychotherapy may optimize treatment effects by modulating neural networks related to cognitive control and emotional regulation. Nevertheless, evidence for such combined interventions in adult ADHD remains limited, particularly with respect to rigorous randomized controlled designs and mechanism-based neuroimaging validation.
Read more
The present study aims to investigate the efficacy and potential mechanisms of tDCS combined with DBT-ST in adults with ADHD. A randomized, double-blind, sham-controlled design will be adopted. Sixty eligible adult participants with ADHD will be randomly assigned to either an active tDCS group or a sham stimulation group, with both groups receiving weekly DBT-ST for ten consecutive weeks. tDCS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) with 2 mA current for 20 minutes, prior to each group therapy session. Clinical symptoms, functional outcomes, and cognitive performance will be assessed at baseline, post-intervention, and one-month follow-up using standardized self-report measures and behavioral tasks. In addition, resting-state functional magnetic resonance imaging (rs-fMRI) will be conducted before and after the intervention to examine changes in functional connectivity within prefrontal regulatory networks.
This study is expected to clarify whether tDCS can enhance the therapeutic effects of DBT-ST on core ADHD symptoms and related functional outcomes, and whether such effects are associated with improvements in executive function, emotion regulation, and alterations in DLPFC-related resting-state functional connectivity. By integrating clinical, behavioral, and neuroimaging measures, the study seeks to provide preliminary evidence for a novel non-pharmacological combined intervention for adult ADHD and to further elucidate its underlying neural mechanisms.
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- adult ADHD, transcranial direct current stimulation, dialectical behavior therapy, DBT skills training, executive function, resting-state fMRI
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS
Transcranial direct current stimulation (tDCS) is administered over the bilateral dorsolateral prefrontal cortex (DLPFC). In the active condition, a constant current of 2 mA is applied for 20 minutes per session, twice prior to each weekly therapy session, for 10 weeks. The anodal electrode is placed over the left DLPFC (F3) and the cathodal electrode over the right DLPFC (F4). In the sham condition, the current is ramped up and down briefly to mimic the sensation of stimulation without delivering an effective dose.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + DBT-ST | Experimental | Participants receive active transcranial direct current stimulation (tDCS) over the bilateral dorsolateral prefrontal cortex combined with dialectical behavior therapy skills training (DBT-ST). Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS + DBT-ST | Sham comparator | Participants receive sham transcranial direct current stimulation (tDCS) combined with dialectical behavior therapy skills training (DBT-ST). Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS)
ADHD symptom severity will be assessed using the Adult ADHD Self-Report Scale (ASRS). The ASRS is a self-administered questionnaire consisting of 18 items. The total score ranges from 0 to 72, with higher scores indicating more severe ADHD symptoms. The primary outcome is the change in ASRS total score from baseline to post-intervention (10 weeks).
Measured: Baseline to 10 weeks (post-intervention)
Secondary outcomes (6)
Change in executive function performance as measured by the Stop-Signal Task (SST)
Executive function will be assessed using the Stop-Signal Task (SST). The outcome measure is the stop-signal reaction time (SSRT), reported in milliseconds. The change in SSRT from baseline to post-intervention will be analyzed.
Measured: Baseline to 10 weeks
Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS)
Emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a 36-item self-report questionnaire. The total score ranges from 36 to 180, with higher scores indicating greater difficulties in emotion regulation. The change in DERS total score from baseline to post-intervention will be evaluated.
Measured: Baseline to 10 weeks (post-intervention)
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a 7-item self-report questionnaire. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. The change in GAD-7 total score from baseline to post-intervention will be evaluated.
Measured: Baseline to 10 weeks (post-intervention)
Change in resting-state functional connectivity within prefrontal regulatory networks
Resting-state functional connectivity will be assessed using resting-state functional magnetic resonance imaging (rs-fMRI). The outcome measure is the strength of functional connectivity within prefrontal regulatory networks, focusing on the dorsolateral prefrontal cortex (DLPFC), and is expressed as Fisher's Z-transformed correlation coefficient. The change in connectivity from baseline to post-intervention will be analyzed.
Measured: Baseline to 10 weeks (post-intervention)
Maintenance of treatment effects at 1-month follow-up
Maintenance of treatment effects will be evaluated by reassessing the following clinical and cognitive outcomes at 1-month follow-up and comparing them with baseline values: ASRS total score (range 0-72, higher = worse), SST stop-signal reaction time (milliseconds), N-back d-prime (unitless), DERS total score (36-180, higher = worse), GAD-7 total score (0-21, higher = worse), PHQ-9 total score (0-27, higher = worse), and rs-fMRI DLPFC functional connectivity (Fisher's Z). Each of these measurements will be analyzed as a separate maintenance endpoint, using the same units of measure as defined in the respective outcomes above.
Measured: 1-month follow-up
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire. The total score ranges from 0 to 27, with higher scores indicating more severe depression. The change in PHQ-9 total score from baseline to post-intervention will be evaluated.
Measured: Baseline to 10 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Apr 2026 (estimated)
- Primary completion21 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Nanjing Medical University
- Investigators
- Chun Wang, PhD, Principal investigator, Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565402
- Sponsor's protocol ID
- 2026-KY022-01
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans are currently undecided. Data may be made available upon reasonable request and subject to institutional approval and participant confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07565402
- Acronym / sponsor ID
- 2026-KY022-01
- Keywords
- adult ADHD, transcranial direct current stimulation, dialectical behavior therapy, DBT skills training, executive function, resting-state fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 21 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 May 2026 (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.
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined with Dialectical Behavior Therapy Skills Training in Adults with Attention-Deficit/Hyperactivity Disorder
Abstract Adult attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that frequently persists into adulthood and is associated with substantial impairments in academic, occupational, and social functioning. Although pharmacological treatment remains the primary intervention, some adults with ADHD show limited response to medication or experience adverse effects, highlighting the need for effective non-pharmacological or combined treatment approaches. Dialectical Behavior Therapy Skills Training (DBT-ST), which emphasizes emotion regulation, impulse control, mindfulness, and behavioral organization, has shown potential in the treatment of adult ADHD. However, its therapeutic efficacy may vary across individuals, and strategies to enhance treatment outcomes still require further investigation. In parallel, transcranial direct current stimulation (tDCS), a safe and non-invasive neuromodulation technique, has attracted increasing attention as an adjunctive intervention in psychiatric disorders. Existing studies suggest that combining tDCS with psychotherapy may optimize treatment effects by modulating neural networks related to cognitive control and emotional regulation. Nevertheless, evidence for such combined interventions in adult ADHD remains limited, particularly with respect to rigorous randomized controlled designs and mechanism-based neuroimaging validation.
The present study aims to investigate the efficacy and potential mechanisms of tDCS combined with DBT-ST in adults with ADHD. A randomized, double-blind, sham-controlled design will be adopted. Sixty eligible adult participants with ADHD will be randomly assigned to either an active tDCS group or a sham stimulation group, with both groups receiving weekly DBT-ST for ten consecutive weeks. tDCS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) with 2 mA current for 20 minutes, prior to each group therapy session. Clinical symptoms, functional outcomes, and cognitive performance will be assessed at baseline, post-intervention, and one-month follow-up using standardized self-report measures and behavioral tasks. In addition, resting-state functional magnetic resonance imaging (rs-fMRI) will be conducted before and after the intervention to examine changes in functional connectivity within prefrontal regulatory networks.
This study is expected to clarify whether tDCS can enhance the therapeutic effects of DBT-ST on core ADHD symptoms and related functional outcomes, and whether such effects are associated with improvements in executive function, emotion regulation, and alterations in DLPFC-related resting-state functional connectivity. By integrating clinical, behavioral, and neuroimaging measures, the study seeks to provide preliminary evidence for a novel non-pharmacological combined intervention for adult ADHD and to further elucidate its underlying neural mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + DBT-ST | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Participants receive active transcranial direct current stimulation (tDCS) over the bilateral dorsolateral prefrontal cortex combined with dialectical behavior therapy skills training (DBT-ST). |
| Sham tDCS + DBT-ST | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants receive sham transcranial direct current stimulation (tDCS) combined with dialectical behavior therapy skills training (DBT-ST). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis confirmed using the Chinese version of the Diagnostic Interview for ADHD in Adults (DIVA-5).
- Aged between 18 and 55 years.
- Right-handed.
- Voluntary participation with provision of written informed consent.
Key exclusion criteria (6 listed)
- Presence of neurological disorders or other psychiatric disorders.
- Severe physical illness.
- Receipt of electroconvulsive therapy (ECT) or other physical treatments within 6 months prior to enrollment.
- Planned changes in ADHD-related medication before the final follow-up assessment.
- Contraindications to tDCS (e.g., intracranial metal or electronic implants, skull plates, or other cranial implants).
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 Stimulation (tDCS)Also: tDCSTranscranial direct current stimulation (tDCS) is administered over the bilateral dorsolateral prefrontal cortex (DLPFC). In the active condition, a constant current of 2 mA is applied for 20 minutes per session, twice prior to each weekly therapy session, for 10 weeks. The anodal electrode is placed over the left DLPFC (F3) and the cathodal electrode over the right DLPFC (F4). In the sham condition, the current is ramped up and down briefly to mimic the sensation of stimulation without delivering an effective dose. | Device | Active tDCS + DBT-ST, Sham tDCS + DBT-ST |
Primary outcome
Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS)
Time frame: Baseline to 10 weeks (post-intervention)
ADHD symptom severity will be assessed using the Adult ADHD Self-Report Scale (ASRS). The ASRS is a self-administered questionnaire consisting of 18 items. The total score ranges from 0 to 72, with higher scores indicating more severe ADHD symptoms. The primary outcome is the change in ASRS total score from baseline to post-intervention (10 weeks).
6 secondary outcomes
Change in executive function performance as measured by the Stop-Signal Task (SST)
Time frame: Baseline to 10 weeks
Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline to 10 weeks (post-intervention)
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline to 10 weeks (post-intervention)
Change in resting-state functional connectivity within prefrontal regulatory networks
Time frame: Baseline to 10 weeks (post-intervention)
Maintenance of treatment effects at 1-month follow-up
Time frame: 1-month follow-up
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to 10 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plans are currently undecided. Data may be made available upon reasonable request and subject to institutional approval and participant confidentiality considerations.
Related trials for Adult Attention Deficit Hyperactivity Disorder
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
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.
Chun Wang, PhD principal investigator
Nanjing Brain Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Adult Attention Deficit Hyperactivity Disorder, run by Nanjing Medical University 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 6 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: looking for participants now, as of the sponsor's last update on 4 May 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun Wang, PhD (15850566376, wang_chun@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS) (time frame: Baseline to 10 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.