tRNS for ADHD

Recruiting at 5 trial locations

Overseen By Cesar Soutullo, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Innosphere

Must not be taking: ADHD medications

Disqualifiers: Severe ODD, Bipolar, Substance abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transcranial random noise stimulation (tRNS) to determine if it can safely and effectively help children with ADHD improve their attention. tRNS is a non-invasive technique that delivers gentle electrical signals to the brain. Participants will receive either the actual tRNS treatment or a sham (inactive) version, both involving a 20-minute session over 10 days. Children with moderate to severe ADHD who have not recently taken ADHD medication might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in ADHD treatment.

Will I have to stop taking my current medications?

Yes, you must stop taking any medications that affect the central nervous system, including ADHD medications, at least 7 days before joining the trial.

What prior data suggests that tRNS is safe for pediatric patients with ADHD?

Research has shown that transcranial random noise stimulation (tRNS) is generally well-tolerated. One study found that tRNS improved thinking and decision-making skills in children with ADHD without causing significant side effects. This suggests the treatment is generally safe for young patients.

tRNS belongs to a group of treatments called transcranial electrical stimulation (tES), known for its safety. This makes tRNS a promising option for children and teenagers with ADHD, as research indicates it is both effective and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tRNS (transcranial random noise stimulation) for ADHD because it offers a non-invasive approach that could provide a new way to manage symptoms. Unlike traditional treatments like medication, which often target neurotransmitter balance, tRNS uses electrical stimulation applied to the scalp to potentially enhance brain function. This method might improve attention and focus without the side effects commonly associated with ADHD medications. Additionally, its non-invasive nature means it could be a safer option for children and adults who struggle with medication adherence or tolerance.

What evidence suggests that tRNS is effective for ADHD?

Research shows that transcranial random noise stimulation (tRNS), a treatment participants in this trial may receive, may help with ADHD. Studies have found that tRNS can improve attention-related skills, such as self-control and memory. Parents have observed improvements in their children's ADHD symptoms following tRNS treatment. Additionally, tRNS has helped individuals with ADHD better judge time. These findings suggest that tRNS might effectively address key symptoms of ADHD. ^{1 2 6 7 8}

Who Is on the Research Team?

Paul Croarkin

Principal Investigator

Mayo Clinic

Eric Storch

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for children aged 7-12 with ADHD who haven't taken medication for it. They'll be part of a study where they receive tRNS, a noninvasive brain stimulation, while playing a game to help focus their attention.

Inclusion Criteria

I haven't taken any brain-effecting drugs, including ADHD meds, in the last week.

Estimated Full Scale IQ ≥ 85 based on WASI-II (Two-subtests Form) or equivalent and validated IQ test performed in the previous 12 months

Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales

Exclusion Criteria

Any other condition that would make the participant unsuitable to participate in this study as determined by the Investigator

I need ADHD medication now due to my impaired functioning.

Known hypersensitivity to Polyamide or Elastomer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each session is 20 minutes.

2 weeks

Follow-up 1

Participants are monitored for changes in ADHD symptom severity and adverse events.

2 weeks

1 visit (in-person)

Follow-up 2

Further monitoring of ADHD symptom severity and adverse events.

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• tRNS

Trial Overview The trial tests if tRNS can safely improve attention in kids with ADHD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets real or sham (fake) treatment during the two-week test period.

How Is the Trial Designed?

Group I: Group A: Treatment Arm Active Control 1 Intervention

The same device placement will be used for sham as in the active arm.

Group II: Group B: Sham-Control Arm Placebo Group 1 Intervention

The same device placement will be used for sham as in the active arm.

Who Is Running the Clinical Trial?

Innosphere

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

Transcranial random noise stimulation (tRNS) can increase cortical excitability for at least 60 minutes after a 10-minute application, but the exact mechanism behind this effect is still being explored.

The study found that the increase in excitability from tRNS can be suppressed by the GABA A agonist lorazepam, indicating that tRNS operates through different mechanisms than transcranial direct current stimulation (tDCS), which is NMDA receptor dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial random noise stimulation-induced plasticity is NMDA-receptor independent but sodium-channel blocker and benzodiazepines sensitive. Chaieb, L., Antal, A., Paulus, W.[2020]

Transcranial random noise stimulation (tRNS) is a non-invasive technique that applies a weak electrical current to the scalp, influencing central motor excitability, with effects lasting beyond the stimulation period.

The mechanism of tRNS appears to involve the modulation of neuronal membrane sodium channels, but further research is needed to fully understand its impact on motor behavior and performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of transcranial random noise stimulation on motor function: A comprehensive review of the literature. Brancucci, A., Rivolta, D., Nitsche, MA., et al.[2023]

In a study involving 22 healthy subjects, neither high-frequency nor low-frequency transcranial random noise stimulation (tRNS) produced significant changes in auditory steady state responses (ASSR) or resting state EEG activity, suggesting limited efficacy of tRNS in modulating these brain activities.

Interestingly, the sham tRNS condition led to a significant decrease in 20Hz ASSR and an increase in alpha frequency band activity, indicating that the act of stimulation itself, even without active tRNS, may influence brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. Schoisswohl, S., Langguth, B., Gebel, N., et al.[2021]

In a study involving 23 unmedicated children with ADHD, high-frequency transcranial random noise stimulation (tRNS) combined with cognitive training led to significant reductions in ADHD symptoms, as reported by parents, after 2 weeks of treatment.

The tRNS treatment also resulted in changes in brain activity, specifically a reduction in beta bandwidth and a more favorable cortical excitation/inhibition balance, suggesting potential cognitive improvements, although no significant differences were found in executive functions or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial random noise stimulation combined with cognitive training for treating ADHD: a randomized, sham-controlled clinical trial. Dakwar-Kawar, O., Mairon, N., Hochman, S., et al.[2023]

In a study with 15 healthy participants, both 1-mA and 2-mA transcranial direct current stimulation (tDCS) significantly increased motor cortical excitability, as measured by motor-evoked potentials, compared to baseline.

Transcranial random noise stimulation (tRNS) alone did not enhance cortical excitability, suggesting that the addition of a direct current offset is necessary for effective stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. Ho, KA., Taylor, JL., Loo, CK.[2015]

Transcranial random noise stimulation (tRNS) is a non-invasive method that can effectively modulate perception and enhance learning in individuals, indicating its potential as a therapeutic tool.

While tRNS shows promise for improving brain function, its effects on higher cognitive processes are inconsistent, suggesting that further research is needed to understand its long-term benefits and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. van der Groen, O., Potok, W., Wenderoth, N., et al.[2022]

Transcranial random noise stimulation (tRNS) applied to the auditory cortex significantly increased auditory steady state responses (ASSRs) in healthy subjects, indicating enhanced excitability of the auditory cortex.

The study involved 14 participants in a placebo-controlled design, and while there was a notable increase in ASSR at 40 Hz, changes in resting state theta band power were not statistically significant, suggesting tRNS may selectively enhance certain auditory processing functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. Van Doren, J., Langguth, B., Schecklmann, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394047/

Transcranial random noise stimulation combined with ... The most notable result is the improvement in parent-reported ADHD symptoms following treatment. These results are in line with our pilot study ...

2. nature.com nature.com/articles/s41598-024-57920-3

Transcranial random noise stimulation (tRNS) improves hot ... The results showed improved ongoing inhibition, prepotent inhibition, working memory, and decision making, but not set-shifting performance, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028393225000405

Transcranial random noise stimulation shifts time ... The findings indicate that tRNS improved time perception accuracy in the ADHD group, bringing their performance closer to accurate time intervals.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0890856725003399

Noninvasive Brain Stimulation in Attention-Deficit ... Meta-analyses indicated that rTMS significantly improved core clinical symptoms and enhanced attention-related cognitive functions in ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.791478/full

Examining the Effect of Transcranial Electrical Stimulation ... Conclusion: This study provides initial support for the efficacy of tRNS combined with CT in improving PS in the presence of mental fatigue in pediatric ADHD.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245721000110

Scaffolding the attention-deficit/hyperactivity disorder brain ... tES has an excellent safety profile, which makes it an appealing treatment method for children and adolescents (Krishnan et al., 2015). Here we used two types ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1364270/full

Efficacy and safety of transcranial pulse stimulation in ... The TPS group will have 30% improvements in attention deficit, hyperactivity and impulsivity after 2 weeks of TPS treatment compared with the sham TPS group, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00001915

Study of Attention Deficit/Hyperactivity Disorder Using ... Studies in adults and children have shown no long-lasting or permanent hearing loss after TMS, but there is no information regarding transient decrease in ...