tDCS for ADHD

Overseen By DNN Inbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Epilepsy, Pregnancy, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

Research Team

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.

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 Overview The 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

Group I: 2mA transcranial direct current stimulation Experimental Treatment 1 Intervention

Group II: 1mA transcranial direct current stimulation Experimental Treatment 1 Intervention

Group III: Sham transcranial direct current stimulation Placebo Group 1 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transcranial magnetic stimulation (rTMS) has shown significant positive effects on ADHD in most studies reviewed, suggesting it could be a viable alternative therapy when traditional medications like methylphenidate are not effective or tolerated.

Transcranial direct current stimulation (tDCS) also demonstrated positive effects in some studies, particularly when used during sleep, but overall evidence is limited, indicating a need for more research to establish its efficacy in ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Noninvasive cerebral stimulation for treatment of ADHD: A review of the literature]. Brandejsky, L., Micoulaud Franchi, JA., Lopez, R., et al.[2018]

Transcranial direct current stimulation (tDCS) appears to be well tolerated and safe for children and adolescents with various psychiatric disorders, based on a review of six studies, including three randomized clinical trials.

However, due to the limited number of studies and the need for more rigorous research, definitive conclusions about its efficacy compared to standard treatments cannot yet be made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. Muszkat, D., Polanczyk, GV., Dias, TG., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) at 1mA for 10 minutes is well tolerated in children and adolescents aged 11-16, with a low rate of adverse events and no serious complications reported.

The study found no signs of harmful effects, such as epileptiform activity, in EEG recordings, suggesting that tDCS is a safe method for modulating brain activity in the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. Moliadze, V., Andreas, S., Lyzhko, E., et al.[2015]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) appears to be safe and well-tolerated in youth, based on a synthesis of studies involving 156 children and a total of 864 active sessions.

The reviewed literature supports the acceptability of tDCS in pediatric populations, with only a small percentage of sessions (4.4%) conducted on neurotypical controls, indicating a focus on clinical subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Buchanan, DM., Bogdanowicz, T., Khanna, N., et al.[2021]

Transcranial direct current stimulation (tDCS) shows partial improvement in cognitive deficits and clinical symptoms of ADHD, with 10 out of 14 studies reporting positive effects on areas like attention and impulsivity.

tDCS was found to be safe, with no serious adverse effects reported across 747 sessions, and different stimulation parameters, such as intensity, may influence its effectiveness, especially in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in ADHD: A Systematic Review of Efficacy, Safety, and Protocol-induced Electrical Field Modeling Results. Salehinejad, MA., Nejati, V., Mosayebi-Samani, M., et al.[2021]

Transcranial direct current stimulation (tDCS) improved long-term memory deficits in an animal model of ADHD (spontaneously hypertensive rats), suggesting potential therapeutic benefits for ADHD symptoms.

tDCS did not affect working memory but did increase reactive oxygen species and antioxidant levels in the brain, indicating a complex mechanism of action that may not involve inflammatory markers.

NCBI (Pubmed)

pubmed.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. Leffa, DT., Bellaver, B., Salvi, AA., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in attention-deficit/hyperactivity disorder: A meta-analysis of clinical efficacy outcomes. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Anodal and Cathodal Transcranial Direct Current Stimulation on DLPFC on Modulation of Inhibitory Control in ADHD. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Noninvasive cerebral stimulation for treatment of ADHD: A review of the literature]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. [2021]

10. Singapore pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in ADHD: A Systematic Review of Efficacy, Safety, and Protocol-induced Electrical Field Modeling Results. [2021]

11. United States pubmed.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]