tRNS for ADHD

Recruiting at 4 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

Trial Summary

What is the purpose of this trial?

A randomized, sham-controlled, double-blind clinical trial to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each treatment session is 20 minutes, during which their attention will be maintained using a software game.

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 data supports the effectiveness of the treatment tRNS for ADHD?

Research shows that tRNS, when combined with cognitive training, led to significant improvements in ADHD symptoms in children, as reported by their parents. These improvements were maintained for at least three weeks after treatment, suggesting a lasting effect. ^{1 2 3 4 5}

Is transcranial random noise stimulation (tRNS) safe for humans?

Research on transcranial random noise stimulation (tRNS) shows it is generally safe, with no significant adverse events reported in studies, including those involving children with ADHD. Some participants experienced longer times to fall asleep and more wake-ups, but overall, tRNS is considered a non-invasive and safe technique. ^{1 2 3 4 6}

How is the treatment tRNS for ADHD different from other treatments?

Transcranial random noise stimulation (tRNS) is a unique, non-invasive brain stimulation technique that uses random electrical currents to potentially improve ADHD symptoms when combined with cognitive training. Unlike traditional medications, tRNS directly targets brain activity and may lead to long-term benefits by engaging brain plasticity mechanisms. ^{1 2 3 4 7}

Research Team

Paul Croarkin

Principal Investigator

Mayo Clinic

Eric Storch

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Meets criteria for ADHD according to DSM-5 using the 'gold standard' procedure

I am between 7 and 12 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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) 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]

References

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

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. [2021]

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

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. [2022]

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

Transcranial random noise stimulation combined with cognitive training for treating ADHD: a randomized, sham-controlled clinical trial. [2023]

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

The effects of transcranial random noise stimulation on motor function: A comprehensive review of the literature. [2023]

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

Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial random noise stimulation-induced plasticity is NMDA-receptor independent but sodium-channel blocker and benzodiazepines sensitive. [2020]