Attention Deficit/Hyperactivity Disorder(ADHD)
Conditions
Keywords
stimulation;, transcranial direct current stimulation (tDCS), Échelle ASRS
Brief summary
Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Double-Blind Controlled Trial
Detailed description
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.
Interventions
OTHERTranscranial 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
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inattention Symptoms Assessed by the Adult ADHD Self-Report Scale (ASRS) from Baseline to Immediately After tDCS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Processing Speed Assessed by the WAIS-IV Coding and Symbol Search Subtests | 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. |
| Change in Working Memory Assessed by the WAIS-IV Digit Span Subtest | 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. |
| Change in Selective Attention Assessed by the d2-R Test of Attention | 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. |
| Change in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale - French Version (DERS-F) | 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. |
| Change in Anxiety and Depression Symptoms Assessed by the Hospital Anxiety and Depression Scale (HADS) | 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. |
| Incidence of Adverse Events Related to tDCS | 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. |
Outcome results
None listed