Attention Deficit Hyperactivity Disorder (ADHD)NCT03870737
Four-week Open-trial Extension TNS for ADHD
A study testing Active TNS 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 will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment. 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 TNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 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 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
- participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
- parents able and willing to monitor proper use of the TNS device and complete all required rating scales
- parent and participants able to compete study rating scales and other measures in English
Who cannot join
- currently requiring any medication with CNS effects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial
The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.
Read the detailed description
This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.
In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.
All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.
During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.
- Being tested
- Active TNS
- Keywords
- ADHD, neuromodulation, trigeminal nerve stimulation
- 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 TNSDevice
Also called Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA
Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.
| Study group | Role | What they receive |
|---|---|---|
| Active TNS | Experimental | Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition. Receives: Device: Active TNS |
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 to 54, with higher scores signifying worse severity.
Measured: Change over Baseline, Week 2, Week 4.
Secondary outcomes (6)
Clinical Global Impression - Improvement (CGI-I)
Categorical measure indicating degree improved or not improved compared with global functioning at baseline in the preceding double-blind trial. The base CGI-I scale is a 7-point measure that requires the investigator to assess how much the condition has improved or worsened compared to baseline prior to initiation of treatment. Ratings are (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6) much worse; (7) very much worse. For purposes of analysis, the measure is dichotomized such that scores <= 2 signify "improved" and scores > 2 signify "not improved."
Measured: Change over Baseline, Week 2, Week 4
Height
A dimensional measure assessed in cm.
Measured: Change over Baseline, Week 2, Week 4
Weight
A dimensional measure assessed in kg.
Measured: Change over Baseline, Week 2, Week 4
Systolic Blood Pressure
A dimensional measure assessed in mm HG.
Measured: Change over Baseline, Week 2, Week 4
Diastolic Blood Pressure
A dimensional measure assessed in mm HG.
Measured: Change over Baseline, Week 2, Week 4
Pulse
A dimensional measure assessed in heart beats per minute.
Measured: Change over Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Dec 2014
- 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT03870737
- Sponsor's protocol ID
- NIH R34MH101282
- Other IDs
- R34MH101282
- Status last verified
- May 2019
- First submitted
- 5 Mar 2019
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial
- ClinicalTrials.gov ID
- NCT03870737
- Acronym / sponsor ID
- NIH R34MH101282
- Keywords
- ADHD, neuromodulation, trigeminal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 26 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 will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.
Detailed description
This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.
In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.
All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.
During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active TNS | Experimental | Device: Active TNSParticipants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
- participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
- parents able and willing to monitor proper use of the TNS device and complete all required rating scales
- parent and participants able to compete study rating scales and other measures in English
Key exclusion criteria (1 listed)
- currently requiring any medication with CNS effects
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 TNSAlso: Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CAParticipants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study. | Device | Active TNS |
Primary outcome
ADHD-IV Rating Scale (ADHD-RS)
Time frame: Change over Baseline, Week 2, Week 4.
A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
6 secondary outcomes
Clinical Global Impression - Improvement (CGI-I)
Time frame: Change over Baseline, Week 2, Week 4
Height
Time frame: Change over Baseline, Week 2, Week 4
Weight
Time frame: Change over Baseline, Week 2, Week 4
Systolic Blood Pressure
Time frame: Change over Baseline, Week 2, Week 4
Diastolic Blood Pressure
Time frame: Change over Baseline, Week 2, Week 4
Pulse
Time frame: Change over Baseline, Week 2, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 TNS 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 4 inclusion and 1 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 29 May 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. 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 26 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, Week 2, Week 4.). 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 29 May 2019.