- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07652788
Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) (TDACS)
Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Double-Blind Controlled Trial
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by attentional difficulties and/or hyperactivity-impulsivity (American Psychiatric Association, 2013). Its treatment is primarily based on a multimodal approach, with first-line pharmacological management using methylphenidate (Ritalin®, Medikinet®, etc.).
However, given the limitations of pharmacological treatments (side effects, contraindications, and risks of misuse), alternative approaches such as transcranial direct current stimulation (tDCS) are generating increasing interest.
tDCS is a non-invasive, safe, and low-cost neuromodulation technique that delivers a low-intensity electrical current through electrodes placed on the scalp. It is well tolerated, with mild and transient adverse effects (tingling sensations, local skin redness, mild fatigue), making it a particularly safe approach. Its low cost and ease of use allow for broad accessibility, including in resource-limited healthcare settings.
In ADHD, tDCS targets the left dorsolateral prefrontal cortex, a key region involved in attention and executive functions. Early studies have reported encouraging results in terms of both efficacy and tolerability, particularly when combined with psychotherapeutic interventions.
The aim of this study is to evaluate the efficacy of tDCS in patients with ADHD.
The findings will support the potential future integration of tDCS into the management of ADHD resistant to conventional treatments.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adult patient aged 18 to 60 years inclusive
- Patient diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD), combined or predominantly inattentive presentation, previously established by a healthcare professional
- Patients must be registered in the active caseload of the Adult Neurodevelopmental Disorders Unit (STNDA)
- Stable psychotropic medication regimen for at least four weeks prior to inclusion, in terms of both molecule and dosage, particularly for methylphenidate, or no current psychotropic treatment. Medication must remain unchanged throughout study participation, unless medically justified changes are required
- Patient with a cognitive status deemed sufficient by the unit's referring psychiatrist to ensure appropriate completion of the scales and tests included in the protocol
- Free, informed, and written consent
Exclusion Criteria:
•General condition impairment (severe fatigue or marked weakness, convalescence after an acute illness or surgery, or recent alcohol consumption)
Psychiatric and neurological disorders
- Diagnosis of Autism Spectrum Disorder (ASD)
- Diagnosis of personality disorder (Cluster A, B, C, or other), according to DSM-5-TR
- Diagnosis of schizophrenia spectrum disorder or other psychotic disorders according to DSM-5-TR
- Diagnosis of bipolar disorder with manic episode or history of manic episodes according to DSM-5-TR
- Confirmed neurological disorder
- Epilepsy or history of epileptic seizures
Medical comorbidities
- Patient with known or suspected cardiac disease
- Patient with severe pulmonary disease
- Patient with cerebrovascular disease (e.g., stroke)
Dermatological and surgical contraindications
- Patient with scalp lesions, open wounds, or skin conditions (severe acne, herpes, burns, skin fissures)
- Patient with severe dermatitis, oozing eczema, or fragile scalp
- Patient with major surgical scars
- Patient with recent craniotomy
Implantable devices and materials
• Patient with a pacemaker or intracranial electrodes, presence of intracranial metal, or skull defects (e.g., post-craniectomy or trepanation without reconstruction)
Other criteria:
- Simultaneous participation in another non-pharmacological intervention provided in the STNDA day hospital (e.g., psychoeducation, cognitive remediation, body expression therapy, emotional regulation training)
- Patient with non-pathological ASRS screening scores (fewer than 4 of the first 6 items rated "Very often")
- Insufficient proficiency in the French language
- Patient under legal guardianship, curatorship, or judicial protection
- Pregnant or breastfeeding patient (based on clinical interview)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore fittizio: tDCS sham
The placebo (sham) treatment will follow an identical protocol in terms of session duration, frequency, and overall procedure.
Stimulation will be simulated, with a brief ramp-up and ramp-down of current at the beginning and end of the session, without actual stimulation during the remainder of the session, in order to mimic the initial sensations of active tDCS.
|
Repeated sessions of transcranial direct current stimulation (tDCS): 5 in-person tDCS sessions Intensity: 2.0 mA Duration: 20 minutes per session Frequency: 5 consecutive days Electrode placement: anode at F3 and cathode at F4 |
|
Sperimentale: tactive tDCS
Active transcranial direct current stimulation (tDCS): 2 mA stimulation for 20 minutes. Repeated sessions of transcranial direct current stimulation (tDCS): 5 in-person tDCS sessions Intensity: 2.0 mA Duration: 20 minutes per session Frequency: 5 consecutive days Electrode placement: anode at F3 and cathode at F4 |
Repeated sessions of transcranial direct current stimulation (tDCS): 5 in-person tDCS sessions Intensity: 2.0 mA Duration: 20 minutes per session Frequency: 5 consecutive days Electrode placement: anode at F3 and cathode at F4 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Inattention Symptoms Assessed by the Adult ADHD Self-Report Scale (ASRS) from Baseline to Immediately After tDCS
Lasso di tempo: Baseline and immediately after the last tDCS session
|
The efficacy of tDCS will be assessed by measuring the change in inattention symptoms using the Adult ADHD Self-Report Scale (ASRS).
The ASRS is a self-report questionnaire used to evaluate ADHD symptoms in adults.
A decrease in the ASRS inattention score indicates an improvement in inattention symptoms.
|
Baseline and immediately after the last tDCS session
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Processing Speed Assessed by the WAIS-IV Coding and Symbol Search Subtests
Lasso di tempo: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
Processing speed will be assessed using the Coding and Symbol Search subtests of the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV).
Changes in scores will be compared between the active tDCS group and the sham tDCS group.
|
Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
|
Change in Working Memory Assessed by the WAIS-IV Digit Span Subtest
Lasso di tempo: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
Working memory will be assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV).
Changes in scores will be compared between the active tDCS group and the sham tDCS group.
|
Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
|
Change in Selective Attention Assessed by the d2-R Test of Attention
Lasso di tempo: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
Selective attention will be assessed using the d2-R Test of Attention.
Changes in attention performance scores will be compared between the active tDCS group and the sham tDCS group.
|
Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
|
Change in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale - French Version (DERS-F)
Lasso di tempo: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
Emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale - French Version (DERS-F).
Changes in emotional regulation scores will be compared between the active tDCS group and the sham tDCS group.
|
Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
|
Change in Anxiety and Depression Symptoms Assessed by the Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Changes in anxiety and depression scores will be compared between the active tDCS group and the sham tDCS group.
|
Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session
|
|
Incidence of Adverse Events Related to tDCS
Lasso di tempo: From the first tDCS session through 6 weeks after the last tDCS session
|
The safety and tolerability of tDCS will be assessed by comparing the frequency and nature of adverse events reported in the active tDCS group and the sham tDCS group.
|
From the first tDCS session through 6 weeks after the last tDCS session
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi del neurosviluppo
- Disturbi da deficit di attenzione e comportamento dirompente
- Disturbo da deficit di attenzione con iperattività
- Terapie
- Discipline e attività comportamentali
- Terapia di stimolazione elettrica
- Terapia convulsiva
- Terapie somatiche psichiatriche
- Elettroshock
- Tecniche psicologiche
- Stimolazione transcranica di corrente continua
Altri numeri di identificazione dello studio
- 2025-A02038-41
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Disturbo da deficit di attenzione/iperattività (ADHD)
-
Wuhan Sports UniversityTerminatoADHD | ADHD - Tipo combinato | ADHD - Tipo disattento | ADHD - Disturbo da deficit di attenzione con iperattività | ADHD in particolare con compromissione della funzione esecutivaCina
-
EMOTIVCompletatoADHD | ADHD - Tipo combinato | ADHD - Disturbo da deficit di attenzione con iperattivitàCorea del Sud
-
St. Antonius HospitalNon ancora reclutamentoADHD | Disturbo da deficit di attenzione con iperattività | Disturbo dell'attenzione | INSERISCI | ADHD Tipo prevalentemente disattento | ADHD, prevalentemente iperattivo - impulsivo | Disturbo da deficit di attenzione (ADD) | Iperattività | Disattenzione | ADHD Tipo prevalentemente iperattivo | ADHD-non altro... e altre condizioni
-
Massachusetts General HospitalRitiratoADHD | Deficit delle funzioni esecutive (EFD)
-
Seattle Children's HospitalReclutamentoADHD | ADHD - Disturbo da deficit di attenzione con iperattivitàStati Uniti
-
Çağlar Charles Daniel JaicksCompletatoADHD | Disturbo da deficit di attenzione e iperattività (ADHD)Turchia (Türkiye)
-
I-Ching ChouBened Biomedical Co., Ltd.Iscrizione su invitoADD/ADHD | ADHD - Disturbo da deficit di attenzione con iperattivitàTaiwan
-
Haukeland University HospitalReclutamentoADHD | ADHD Tipo prevalentemente disattento | ADHD - Tipo combinato | ADHD, prevalentemente iperattivo - impulsivoNorvegia
-
Qbtech ABIscrizione su invitoDisturbo da deficit di attenzione e iperattività (ADHD) | Volontariato sano | Nessuna storia di ADHDStati Uniti
-
Children's National Research InstituteReclutamentoADHD | Sindrome da deficit di attenzione e iperattività | Sindrome da deficit di attenzione e iperattività | Disturbo dell'attenzione | INSERISCI | ADHD Tipo prevalentemente disattento | ADHD - Tipo combinato | ADHD, prevalentemente iperattivo - impulsivo | Disturbo da deficit di attenzione nell'adolescenza e altre condizioniStati Uniti
Prove cliniche su Transcranial direct current stimulation (tDCS)
-
The University of Texas Health Science Center,...Completato
-
Minneapolis Veterans Affairs Medical CenterCenter for Veterans Research and EducationCompletatoObesità | Impulsività | Eccesso di cibo compulsivoStati Uniti
-
Insel Gruppe AG, University Hospital BernReclutamentoMetastasi al cervelloSvizzera
-
University of FloridaReclutamento
-
Angiodynamics, Inc.CompletatoCarcinoma, epatocellulareFrancia, Germania, Italia, Spagna