ADHDNCT06189703
tRNS Treatment for ADHD Symptoms
A study testing tRNS in people with ADHD, run by Innosphere at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- tRNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Jul 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 7-12 years old at the time of enrollment
- Estimated Full Scale IQ ≥ 85 based on WASI-II (Two-subtests Form) NOTE: Results of an equivalent and validated IQ test that were performed in the previous 12 months from the date of enrollment are acceptable. The Investigator must ensure that no significant head injuries, particularly significant head trauma, occurred in this period from the previous test to the enrollment.
- Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales
- Meet criteria for ADHD according to DSM-5, using the "gold standard" procedure as described by the American Academy of Pediatrics, which includes a semi-structured interview of the subject and parent(s)/legal guardian(s)
- Moderate to severe ADHD as defined as having a minimum score of 12 on either the inattention subscale or the and hyperactivity-impulsivity subscale of the baseline ADHD Rating Scale (ADHD-RS), and a Clinical Global Impression-Severity (CGI-S) score at baseline of greater than 4
- Parent(s)/legal guardian(s) fluent in English, able to complete ADHD-RS scale and attend all study visits
- Has not taken any medication with central nervous system effects, including prescription medications for ADHD, within 7 days of enrollment, as determined by the investigator based on the subject's medical history from the parent(s)/legal guardian(s) and, as applicable, medical and pharmacy records
Who cannot join
- Has a history of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) reduce the subject's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results
- Primary DSM-5 axis-1 disorder other than ADHD, which consists of one or more of severe ODD, bipolar psychosis, major depressive disorder, severe oppositional defiant disorder that would pose adherence challenges by the investigator
- Substance abuse, that, in the opinion of the investigator, may: (1) reduce the participant's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results
- Impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the Investigator
- Known hypersensitivity to Polyamide or Elastomer
- Any suicide risk as assessed with the Columbia-Suicide Severity Rating Scale (Pediatric (≤11 years) Quick Screen)
Show all 9Show fewer
- If female, began menstruation, based on a self- or parent(s)/legal guardian(s)-report
- Any other condition, which would make the participant unsuitable to participate in this study as determined by the Investigator
- Inability to provide informed consent and assent (participant and parent(s)/legal guardian(s))
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Baylor College of Medicine Department of Psychiatry & Behavioral Sciences
Houston, Texas, 77030
UTHealth Houston
Houston, Texas, 77030
Mayo Clinic Hospital, Methodist Campus
Rochester, Minnesota, 55902
About this study
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.
- Conditions
- ADHD
- Being tested
- tRNS
- Keywords
- Pediatric
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tRNSDevice
Also called Novostim 2
transcranial random noise stimulation applied to the right IFG and the left DLPFC
| Study group | Role | What they receive |
|---|---|---|
| Group A: Treatment Arm | Active comparator | The same device placement will be used for sham as in the active arm. Receives: Device: tRNS |
| Group B: Sham-Control Arm | Sham comparator | The same device placement will be used for sham as in the active arm. Receives: Device: tRNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD symptom severity during treatment
Change in ADHD symptom severity, measured by total score of parent-reported ADHD-RS questionnaire from baseline to End of Treatment (Week 2) compared to sham control.
Measured: Baseline to End of Treatment (Week 2)
Incidence of adverse events
Incidence of adverse events (AEs), including serious adverse events (SAEs) related to Novostim 2 treatment
Measured: Baseline to Week 10
Secondary outcomes (3)
Change in ADHD symptom severity post-treatment
Change in ADHD-RS from baseline to follow-up (Week 4 and Week 10) compared to sham control
Measured: Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)
Change in ADHD-RS subscales
Change in ADHD-RS subscales (either inattention or hyperactivity-impulsivity subscales) from baseline to end of treatment and follow-up (Week 4 and Week 10) compared to sham control
Measured: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
GCI-I score
CGI-I score at end of treatment and follow-up (Week 4 and Week 10) compared to sham control
Measured: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Jul 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, sham-controlled between groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innosphere
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189703
- Sponsor's protocol ID
- TRNS-CLIN-003
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tRNS Treatment for ADHD Symptoms
- ClinicalTrials.gov ID
- NCT06189703
- Acronym / sponsor ID
- TRNS-CLIN-003
- Conditions
- ADHD
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- InnosphereIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-controlled between groups
| Arm | Type | Receives |
|---|---|---|
| Group A: Treatment Arm | Active comparator | Device: tRNSThe same device placement will be used for sham as in the active arm. |
| Group B: Sham-Control Arm | Sham comparator | Device: tRNSThe same device placement will be used for sham as in the active arm. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 7-12 years old at the time of enrollment
- Estimated Full Scale IQ ≥ 85 based on WASI-II (Two-subtests Form) NOTE: Results of an equivalent and validated IQ test that were performed in the previous 12 months from the date of enrollment are acceptable. The Investigator must ensure that no significant head injuries, particularly significant head trauma, occurred in this period from the previous test to the enrollment.
- Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales
- Meet criteria for ADHD according to DSM-5, using the "gold standard" procedure as described by the American Academy of Pediatrics, which includes a semi-structured interview of the subject and parent(s)/legal guardian(s)
- Moderate to severe ADHD as defined as having a minimum score of 12 on either the inattention subscale or the and hyperactivity-impulsivity subscale of the baseline ADHD Rating Scale (ADHD-RS), and a Clinical Global Impression-Severity (CGI-S) score at baseline of greater than 4
Key exclusion criteria (9 listed)
- Has a history of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) reduce the subject's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results
- Primary DSM-5 axis-1 disorder other than ADHD, which consists of one or more of severe ODD, bipolar psychosis, major depressive disorder, severe oppositional defiant disorder that would pose adherence challenges by the investigator
- Substance abuse, that, in the opinion of the investigator, may: (1) reduce the participant's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results
- Impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the Investigator
- Known hypersensitivity to Polyamide or Elastomer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tRNSAlso: Novostim 2transcranial random noise stimulation applied to the right IFG and the left DLPFC | Device | Group A: Treatment Arm, Group B: Sham-Control Arm |
Primary outcome
Change in ADHD symptom severity during treatment
Time frame: Baseline to End of Treatment (Week 2)
Change in ADHD symptom severity, measured by total score of parent-reported ADHD-RS questionnaire from baseline to End of Treatment (Week 2) compared to sham control.
Incidence of adverse events
Time frame: Baseline to Week 10
Incidence of adverse events (AEs), including serious adverse events (SAEs) related to Novostim 2 treatment
3 secondary outcomes
Change in ADHD symptom severity post-treatment
Time frame: Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)
Change in ADHD-RS subscales
Time frame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
GCI-I score
Time frame: Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tRNS in people with ADHD, run by Innosphere at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD symptom severity during treatment (time frame: Baseline to End of Treatment (Week 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.