- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07565402
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chun Wang, PhD
- Telefonní číslo: 15850566376
- E-mail: wang_chun@nju.edu.cn
Studijní záloha kontaktů
- Jméno: Yu Xin Luo
- Telefonní číslo: 18982002847
- E-mail: felicia18982002847@163.com
Studijní místa
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína, 210029
- Nábor
- Nanjing Brain Hospital
-
Kontakt:
- Chun Wang, PhD
- Telefonní číslo: 15850566376
- E-mail: wang_chun@nju.edu.cn
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Active tDCS + DBT-ST
Participants receive active transcranial direct current stimulation (tDCS) over the bilateral dorsolateral prefrontal cortex combined with dialectical behavior therapy skills training (DBT-ST).
|
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.
Ostatní jména:
|
|
Falešný srovnávač: Sham tDCS + DBT-ST
Participants receive sham transcranial direct current stimulation (tDCS) combined with dialectical behavior therapy skills training (DBT-ST).
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in ADHD symptoms as measured by the Adult ADHD Self-Report Scale (ASRS)
Časové okno: 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).
|
Baseline to 10 weeks (post-intervention)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in executive function performance as measured by the Stop-Signal Task (SST)
Časové okno: Baseline to 10 weeks
|
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.
|
Baseline to 10 weeks
|
|
Change in emotion regulation ability as measured by the Difficulties in Emotion Regulation Scale (DERS)
Časové okno: Baseline to 10 weeks (post-intervention)
|
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.
|
Baseline to 10 weeks (post-intervention)
|
|
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7)
Časové okno: Baseline to 10 weeks (post-intervention)
|
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.
|
Baseline to 10 weeks (post-intervention)
|
|
Change in resting-state functional connectivity within prefrontal regulatory networks
Časové okno: Baseline to 10 weeks (post-intervention)
|
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.
|
Baseline to 10 weeks (post-intervention)
|
|
Maintenance of treatment effects at 1-month follow-up
Časové okno: 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.
|
1-month follow-up
|
|
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Časové okno: Baseline to 10 weeks (post-intervention)
|
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.
|
Baseline to 10 weeks (post-intervention)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Chun Wang, PhD, Nanjing Brain Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Neurologické vývojové poruchy
- Deficit pozornosti a rušivé poruchy chování
- Porucha pozornosti s hyperaktivitou
- Terapeutika
- Disciplíny a činnosti chování
- Elektrická stimulační terapie
- Kvisulská terapie
- Psychiatrické somatické terapie
- Electroshock
- Psychologické techniky
- Transkraniální stimulace přímého proudu
Další identifikační čísla studie
- 2026-KY022-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Transcranial Direct Current Stimulation (tDCS)
-
Rennes University HospitalDokončeno
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Zápis na pozvánkuPARKINSONOVA NEMOC (porucha)Itálie
-
The Hong Kong Polytechnic UniversityNáborChronická mrtviceHongkong
-
Beijing Sport UniversityZatím nenabírámeTranskraniální stimulace stejnosměrným proudem
-
Anhui Medical UniversityAktivní, ne náborKognitivní porucha | Přežil rakovinu prsu | Transkraniální stimulace stejnosměrným proudem (tDCS)Čína
-
University of MichiganDokončenoPoruchy temporomandibulárního kloubu
-
Arcadia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...NáborFunkce čtyřhlavého svalu | Rekonstrukční rehabilitace předního zkříženého vazuSpojené státy
-
Centro Universitário Augusto MottaAktivní, ne náborNeuromodulace | Úzkost z výkonu | Hudební vystoupeníBrazílie
-
National Institute of Mental Health and Neuro Sciences...NáborSchizofrenie | Schizoafektivní poruchaIndie