60 Participants Needed

tDCS for ADHD

BA
JC
ON
DI
Overseen ByDNN Inbox
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing if home-based tDCS can help people with ADHD by using a small electrical current to improve brain function. It aims to make advanced treatments more accessible by allowing patients to use the therapy at home. Transcranial direct current stimulation (tDCS) has been studied for its potential to improve cognitive functions in ADHD, showing promise in enhancing attention, inhibitory control, and working memory.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for ADHD?

Research suggests that transcranial direct current stimulation (tDCS) may help improve symptoms of inattention in adults with ADHD, although studies often have small sample sizes and varied methods. Additionally, tDCS has been explored for improving inhibitory control in adolescents with ADHD symptoms.12345

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe in humans, with no serious adverse effects reported in over 33,200 sessions across various populations, including children and adults with ADHD. However, caution is advised as the effects on the developing brain are not fully understood, and some studies suggest potential risks.678910

How does tDCS treatment for ADHD differ from other treatments?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive treatment that uses a mild electrical current to modulate brain activity, potentially improving symptoms like inattention and inhibitory control in ADHD. Unlike medications, which are taken orally, tDCS is applied directly to the scalp and may offer an alternative for those who prefer non-drug therapies.123411

Research Team

JC

Joan Camprodon, MD, PHD, MPH

Principal Investigator

MGB: Division of Neuropsychiatry and Neuromodulation

Eligibility Criteria

This trial is for adults aged 18-65 with a diagnosis of ADHD according to DSM-5 criteria. It's not suitable for pregnant or nursing women, individuals with epilepsy, metallic head/neck implants, brain stimulators, pacemakers, active substance dependence (except tobacco), or severe psychiatric disorders like bipolar disorder and schizophrenia.

Inclusion Criteria

I am between 18 and 65 years old.
I have been diagnosed with ADD/ADHD.

Exclusion Criteria

You cannot participate if you have a history of epilepsy, have metal implants in your head or neck, have brain or vagus nerve stimulators, have a VP shunt, have a pacemaker, or are pregnant.
I have a history of serious brain conditions or severe mental health issues.
Pregnant or nursing females.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based transcranial direct current stimulation (tDCS) daily for 30 days to assess its efficacy on ADHD symptoms and cognitive control

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of P300 amplitude and ADHD symptomatology

4 weeks

Treatment Details

Interventions

  • 1 mA transcranial direct current stimulation (tDCS)
  • 2 mA transcranial direct current stimulation (tDCS)
  • Sham transcranial direct current stimulation (tDCS)
Trial OverviewThe study tests if home-based tDCS can reduce ADHD symptoms and improve cognitive control over four weeks. Participants will receive either a low dose (1 mA), high dose (2 mA) of stimulation, or a sham treatment to compare effectiveness.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2mA transcranial direct current stimulationExperimental Treatment1 Intervention
Group II: 1mA transcranial direct current stimulationExperimental Treatment1 Intervention
Group III: Sham transcranial direct current stimulationPlacebo Group1 Intervention

2 mA transcranial direct current stimulation (tDCS) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Transcranial Direct Current Stimulation for:
  • Attention-deficit/hyperactivity disorder (ADHD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

Transcranial direct current stimulation (tDCS) has shown immediate effects on overall ADHD symptoms, particularly inattention and impulsivity, in a meta-analysis of 13 studies involving 308 participants, mostly children and adolescents.
Follow-up results indicate that tDCS may provide lasting benefits for overall symptom severity and even a delayed improvement in hyperactivity, suggesting it could be a promising treatment option for ADHD.
Transcranial direct current stimulation in attention-deficit/hyperactivity disorder: A meta-analysis of clinical efficacy outcomes.Brauer, H., Breitling-Ziegler, C., Moliadze, V., et al.[2021]
Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) improved inhibitory control in adolescents with ADHD symptoms, particularly enhancing correct responses during the Go stage of the Go/No-Go task.
Cathodal stimulation on the left DLPFC significantly increased inhibition accuracy during the inhibition stage of the Go/No-Go task, suggesting that tDCS can be an effective intervention for improving specific cognitive functions in ADHD.
Effect of Anodal and Cathodal Transcranial Direct Current Stimulation on DLPFC on Modulation of Inhibitory Control in ADHD.Soltaninejad, Z., Nejati, V., Ekhtiari, H.[2020]
A randomized clinical trial involving 64 adults with ADHD showed that home-based transcranial direct current stimulation (tDCS) significantly improved inattention symptoms over 4 weeks compared to a sham treatment, indicating its potential as an effective nonpharmacological intervention.
While tDCS was generally safe, mild adverse effects like skin redness and headaches were reported more frequently in the active treatment group, suggesting that while effective, monitoring for side effects is important.
Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial.Leffa, DT., Grevet, EH., Bau, CHD., et al.[2023]

References

Transcranial direct current stimulation in attention-deficit/hyperactivity disorder: A meta-analysis of clinical efficacy outcomes. [2021]
Effect of Anodal and Cathodal Transcranial Direct Current Stimulation on DLPFC on Modulation of Inhibitory Control in ADHD. [2020]
Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial. [2023]
[Noninvasive cerebral stimulation for treatment of ADHD: A review of the literature]. [2018]
Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. [2018]
Safety of transcranial direct current stimulation in healthy participants. [2021]
Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. [2015]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. [2021]
Transcranial Direct Current Stimulation in ADHD: A Systematic Review of Efficacy, Safety, and Protocol-induced Electrical Field Modeling Results. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Transcranial direct current stimulation improves long-term memory deficits in an animal model of attention-deficit/hyperactivity disorder and modulates oxidative and inflammatory parameters. [2019]