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Efficacy of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Double-Blind Controlled Trial
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS sham | Sham Comparator | 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. |
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| tactive tDCS | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inattention Symptoms Assessed by the Adult ADHD Self-Report Scale (ASRS) from Baseline to Immediately After tDCS | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Processing Speed Assessed by the WAIS-IV Coding and Symbol Search Subtests | 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 |
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Inclusion Criteria:
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
Medical comorbidities
Dermatological and surgical contraindications
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:
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parallel assignment
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Double (Participant, Investigator)
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| Change in Working Memory Assessed by the WAIS-IV Digit Span Subtest | 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 | 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) | 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) | 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 | 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 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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