Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Официальное название

Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Double-Blind Controlled Trial

Обзор

Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Double-Blind Controlled Trial

Подробное описание

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.

Вмешательства

• Другое Transcranial direct current stimulation (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

Первичные конечные точки

• Change in Inattention Symptoms Assessed by the Adult ADHD Self-Report Scale (ASRS) from Baseline to Immediately After tDCS [Срок оценки: Baseline and immediately after the last tDCS session]

Вторичные конечные точки (6)

• Change in Processing Speed Assessed by the WAIS-IV Coding and Symbol Search Subtests [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, immediately after the last tDCS session, and 6 weeks after the last tDCS session]
• Incidence of Adverse Events Related to tDCS [Срок оценки: From the first tDCS session through 6 weeks after the last tDCS session]

Критерии участия

Критерии включения

• 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

Критерии исключения

•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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07652788 · 2025-A02038-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗