Attention Deficit Hyperactivity Disorder (ADHD)TNS for ADHDNCT02155608
Trigeminal Nerve Stimulation for ADHD
A study testing Active eTNS in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD). Study hypothesis address potential differences over 4 weeks of active vs. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Active eTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 30 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male and female children ages 8 to 12 years with DSM-5 ADHD, any current presentation, as determined by KSADS and clinical interview
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
- CGI-S score at baseline ≥ 4
- no current medication with CNS effects
- parents able and willing to monitor proper use of the stimulation device and complete all required rating scales
- estimated Full Scale IQ ≥ 85 based on WASI subtests
- parent and participant able to complete rating scales and other measures in English
- able to cooperate during EEG
Who cannot join
- impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator
- current diagnosis of autism spectrum disorder or major depression
- history of lifetime psychosis, mania, seizure disorder or head injury with loss of consciousness
- baseline suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD
The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).
Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.
Read the detailed description
This three-year developmental study is a double-blind randomized trial of active vs. inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional one week of clinical observation and testing after treatment cessation.
The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and clinical interview.
Other screening procedures include measures of ADHD symptom severity, other behavioral ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and verified, participants in Phase 1A will have a pre-treatment visit to establish behavioral and cognitive baseline ratings and to obtain an EEG. Participants and parents will be instructed in the use of eTNS, and participants will begin use of the eTNS as directed during sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants, families, and most of the study team will remain blind to treatment assignment. Participants will have weekly assessments over the five-week study to assess behavioral, cognitive, and brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will occur at baseline, end of treatment (week 4).
In Phase 1B, all participants remain blinded for one week after cessation of the intervention and return for a final visit to assess residual effects of eTNS therapy vs. sham.
- Being tested
- Active eTNS, Sham eTNS
- Keywords
- ADHD, neuromodulation, trigeminal nerve stimulation, cognition
- 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.
Active eTNSDevice
Also called Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA
Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.
Sham eTNSDevice
Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.
| Study group | Role | What they receive |
|---|---|---|
| Active eTNS | Experimental | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension. Receives: Device: Active eTNS |
| Sham eTNS | Sham comparator | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension. Receives: Device: Sham eTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-IV Rating Scale (ADHD-RS)
A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
Measured: Change over baseline and weeks 1, 2, 3, 4 and 5.
Secondary outcomes (13)
Clinical Global Impression - Improvement (CGI-I)
Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as "Improved" (CGI-I <=2) or "Not Improved" (CGI-I > 2).
Measured: Change over weeks 1, 2, 3, 4, and 5 compared with baseline.
Conners Global Index - Parent Report
Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms.
Measured: Change over baseline and weeks 1, 2, 3, 4, 5.
Affective Reactivity Index (ARI) - Child
A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Measured: Change over baseline and weeks 4 and 5.
Affective Reactivity Index (ARI) - Parent Report
A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Measured: Change over baseline and weeks 4 and 5.
Multidimensional Anxiety Scale for Children (MASC) - Child Report
A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Measured: Change over baseline and weeks 4 and 5.
Multidimensional Anxiety Scale for Children (MASC) - Parent Report
A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Measured: Change over baseline and weeks 4 and 5.
Height
A dimensional measure assessed in centimeters (cm).
Measured: Change over baseline and weeks 1, 4, and 5.
Weight
A dimensional measure assessed in kilograms (kg).
Measured: Change over baseline and weeks 1, 4, and 5.
Systolic Blood Pressure
A dimensional measure expressed in mm mercury (Hg).
Measured: Change over baseline and weeks 1, 4, and 5.
Diastolic Blood Pressure
A dimensional measure assessed in mm mercury (Hg).
Measured: Change over baseline and weeks 1, 4, and 5.
Pulse
Heart rate in beats per minute (bpm).
Measured: Change over baseline and weeks weeks 1, 4, and 5.
Children's Depression Inventory (CDI)
A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores < 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression.
Measured: Change over baseline and weeks 4 and 5.
Conners Global Index - Teacher
Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.
Measured: Change over baseline and weeks 1, 2, 3, 4, 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start1 Apr 2015
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James McGough, University of California, Los Angeles
- Investigators
- James J McGough, M.D., Principal investigator, University of California, Los AngelesSandra K Loo, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155608
- Sponsor's protocol ID
- NIMH R34MH101282
- Other IDs
- R34MH101282
- Acronym
- TNS for ADHD
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2014
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, Cook IA, Sugar CA, Loo SK. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28.
PubMed 30768393Loo SK, Salgari GC, Ellis A, Cowen J, Dillon A, McGough JJ. Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):856-864.e1. doi: 10.1016/j.jaac.2020.09.021. Epub 2020 Oct 15.
PubMed 33068751
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD
- ClinicalTrials.gov ID
- NCT02155608
- Acronym / sponsor ID
- TNS for ADHD / NIMH R34MH101282
- Keywords
- ADHD, neuromodulation, trigeminal nerve stimulation, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 12 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).
Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.
Detailed description
This three-year developmental study is a double-blind randomized trial of active vs. inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional one week of clinical observation and testing after treatment cessation.
The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and clinical interview.
Other screening procedures include measures of ADHD symptom severity, other behavioral ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and verified, participants in Phase 1A will have a pre-treatment visit to establish behavioral and cognitive baseline ratings and to obtain an EEG. Participants and parents will be instructed in the use of eTNS, and participants will begin use of the eTNS as directed during sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants, families, and most of the study team will remain blind to treatment assignment. Participants will have weekly assessments over the five-week study to assess behavioral, cognitive, and brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will occur at baseline, end of treatment (week 4).
In Phase 1B, all participants remain blinded for one week after cessation of the intervention and return for a final visit to assess residual effects of eTNS therapy vs. sham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active eTNS | Experimental | Device: Active eTNSFollowing screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension. |
| Sham eTNS | Sham comparator | Device: Sham eTNSFollowing screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- male and female children ages 8 to 12 years with DSM-5 ADHD, any current presentation, as determined by KSADS and clinical interview
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
- CGI-S score at baseline ≥ 4
- no current medication with CNS effects
- parents able and willing to monitor proper use of the stimulation device and complete all required rating scales
Key exclusion criteria (4 listed)
- impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator
- current diagnosis of autism spectrum disorder or major depression
- history of lifetime psychosis, mania, seizure disorder or head injury with loss of consciousness
- baseline suicidality
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 |
|---|---|---|
| Active eTNSAlso: Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CAParticipants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period. | Device | Active eTNS |
| Sham eTNSParticipants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period. | Device | Sham eTNS |
Primary outcome
ADHD-IV Rating Scale (ADHD-RS)
Time frame: Change over baseline and weeks 1, 2, 3, 4 and 5.
A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
13 secondary outcomes
Clinical Global Impression - Improvement (CGI-I)
Time frame: Change over weeks 1, 2, 3, 4, and 5 compared with baseline.
Conners Global Index - Parent Report
Time frame: Change over baseline and weeks 1, 2, 3, 4, 5.
Affective Reactivity Index (ARI) - Child
Time frame: Change over baseline and weeks 4 and 5.
Affective Reactivity Index (ARI) - Parent Report
Time frame: Change over baseline and weeks 4 and 5.
Multidimensional Anxiety Scale for Children (MASC) - Child Report
Time frame: Change over baseline and weeks 4 and 5.
Multidimensional Anxiety Scale for Children (MASC) - Parent Report
Time frame: Change over baseline and weeks 4 and 5.
Height
Time frame: Change over baseline and weeks 1, 4, and 5.
Weight
Time frame: Change over baseline and weeks 1, 4, and 5.
Systolic Blood Pressure
Time frame: Change over baseline and weeks 1, 4, and 5.
Diastolic Blood Pressure
Time frame: Change over baseline and weeks 1, 4, and 5.
Pulse
Time frame: Change over baseline and weeks weeks 1, 4, and 5.
Children's Depression Inventory (CDI)
Time frame: Change over baseline and weeks 4 and 5.
Conners Global Index - Teacher
Time frame: Change over baseline and weeks 1, 2, 3, 4, 5.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30768393McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, Cook IA, Sugar CA, Loo SK. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28.
- Derived from this study: PubMed 33068751Loo SK, Salgari GC, Ellis A, Cowen J, Dillon A, McGough JJ. Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):856-864.e1. doi: 10.1016/j.jaac.2020.09.021. Epub 2020 Oct 15.
- Pub Med AbstractLink provided by the sponsor.
- 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.
James J McGough, M.D. principal investigator
University of California, Los Angeles
Sandra K Loo, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active eTNS in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of California, Los Angeles at 1 site in United States.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ADHD-IV Rating Scale (ADHD-RS) (time frame: Change over baseline and weeks 1, 2, 3, 4 and 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02155608, which also lists 2 linked publications.
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 2 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.