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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a home-based brain stimulation treatment, transcranial direct current stimulation (tDCS), can reduce ADHD symptoms and improve cognitive control. Participants will use a device that delivers a small electrical current to the brain. The study compares different levels of stimulation to determine the most effective one. Individuals with ADHD who struggle with attention and decision-making may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new ADHD treatments.

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 prior data suggests that transcranial direct current stimulation (tDCS) is safe for ADHD?

Research has shown that transcranial direct current stimulation (tDCS) is safe for people with ADHD. Studies have found that both adults and children tolerate tDCS well. For instance, one study showed that tDCS was safe and improved attention in adults with ADHD. Another study found that teenagers also benefited, with improvements in working memory, which refers to how information is held and used in the mind. Importantly, these studies did not identify any major safety issues with tDCS. This indicates that the treatment is generally considered safe for both the 2 mA and 1 mA levels being tested in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard ADHD treatments that typically involve medications like stimulants or non-stimulants, transcranial direct current stimulation (tDCS) offers a non-invasive alternative by using a mild electrical current to potentially improve attention and focus. Researchers are excited about tDCS because it targets brain activity directly without the side effects associated with medication. Additionally, this method provides flexibility in treatment, with variations like 2mA and 1mA stimulations, allowing for tailored approaches to individual needs. The sham comparator arm helps ensure that any effects observed are due to the stimulation itself, offering a robust assessment of its true potential.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research shows that transcranial direct current stimulation (tDCS) can help with ADHD symptoms. In this trial, participants will receive either a 2 mA or 1 mA level of tDCS, or a sham treatment. Earlier studies found that a 2 mA level of tDCS improved focus and emotional control in both children and adults with ADHD. It also helped individuals stay on task longer. Studies also indicate that a 1 mA level of tDCS effectively improves memory and helps control impulsive actions. Both levels have been safe and well-tolerated in these studies. Overall, tDCS seems promising for managing ADHD symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Joan Camprodon, MD, PHD, MPH

Principal Investigator

MGB: Division of Neuropsychiatry and Neuromodulation

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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 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) 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) 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) 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]

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 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) 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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05354232

Home-based Transcranial Direct Current Stimulation (tDCS ...

An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most ...

2.

nature.com

nature.com/articles/s41598-024-64886-9

Transcranial direct current stimulation (tDCS) improves ...

The results of the present study indicate significant improvement of emotional pre-potent inhibition and emotional working memory in ADHD ...

3.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2794932

Transcranial Direct Current Stimulation vs Sham for the ...

tDCS was a safe and well-tolerated effective treatment for inattention in adults with ADHD in this trial.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7532240/

Transcranial Direct Current Stimulation in ADHD

A recently published meta-analysis on the effects of tDCS on response inhibition and working memory in ADHD showed a significant tDCS effect.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0079612321000133

Transcranial direct current stimulation in attention-deficit ...

The first meta-analysis describing the use of tDCS in ADHD (Salehinejad et al., 2019) showed that tDCS can improve cognitive functions such as working memory ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12342835/

Efficacy and safety of transcranial direct current stimulation for ...

Among adolescents with ADHD, tDCS had a significant effect on working memory performance, particularly for tasks with high complexity and high memory load.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X24001335

Transcranial direct current stimulation enhances effort ...

tDCS targeting the ventromedial PFC (anodal) and right dorsolateral PFC (cathodal) increases effort maintenance in children and adolescents with ADHD.

8.

joghnp.scholasticahq.com

joghnp.scholasticahq.com/article/128244-transcranial-direct-current-stimulation-on-attention-cognitive-function-in-adults-with-attention-deficit-hyperactivity-disorder

Transcranial direct current stimulation on attention cognitive ...

The aim of this work was to determine the effect of tDCS as an adjunct to standard treatment on cognitive attention function in adults with ADHD.