Attention-Deficit/Hyperactivity DisorderEarly Phase 1NCT01388530
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
A Early Phase 1 study testing EMS 7500 Digital Muscle Stimulator in people with Attention-Deficit/Hyperactivity Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- EMS 7500 Digital Muscle Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2012
- Phase
- Early Phase 1
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S
- Clinical Global Impression- Severity (CGI-S) score at baseline
- no current medications with central nervous system (CNS) affects
- parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.
Who cannot join
- impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression.
- history of lifetime psychosis or mania
- current suicidality
- history of seizure disorder, tic disorder, or head injury with loss of consciousness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- EMS 7500 Digital Muscle Stimulator
- 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.
EMS 7500 Digital Muscle StimulatorDevice
A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
| Study group | Role | What they receive |
|---|---|---|
| trigeminal nerve stimulation | Experimental | Open label treatment with trigeminal nerve stimulation in an 8-week trial. Receives: Device: EMS 7500 Digital Muscle Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-IV Rating Scale (ADHD-RS)
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.
Scale ranges from 0 (best) to 54 (worst).
Unit of Measure - units on a scale.
Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
Measured: Baseline and Week 8.
Secondary outcomes (3)
Clinical Global Impression - Improvement (CGI-I)
A global measure of clinical improvement compared with baseline.
A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).
Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others.
Measured: Week 8
Conners Global Index - Parent
A standard, parent completed measure of ADHD symptoms.
Scale range from 0 (best) to 27 (worst).
Unit of Measure - units on a scale.
Outcome value reflects change from baseline at endpoint (Week 8).
Measured: Baseline and Week 8.
Attention Network Task - Incongruent Reaction Time
Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.
Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome.
Measured: Baseline and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
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 DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroSigma, Inc.
- Responsible party
- Principal investigator, James McGough, University of California, Los Angeles
- Investigators
- James J McGough, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388530
- Sponsor's protocol ID
- UCLA-TNS/ADHD
- Status last verified
- Mar 2016
- First submitted
- 24 Jun 2011
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01388530
- Acronym / sponsor ID
- UCLA-TNS/ADHD
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- NeuroSigma, Inc.
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trigeminal nerve stimulation | Experimental | Device: EMS 7500 Digital Muscle StimulatorOpen label treatment with trigeminal nerve stimulation in an 8-week trial. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S
- Clinical Global Impression- Severity (CGI-S) score at baseline
- no current medications with central nervous system (CNS) affects
- 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; 2) current diagnosis of pervasive developmental disorder or major depression.
- history of lifetime psychosis or mania
- current suicidality
- history of seizure disorder, tic disorder, or head injury with loss of consciousness.
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 |
|---|---|---|
| EMS 7500 Digital Muscle StimulatorA standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep. | Device | trigeminal nerve stimulation |
Primary outcome
ADHD-IV Rating Scale (ADHD-RS)
Time frame: Baseline and Week 8.
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
3 secondary outcomes
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 8
Conners Global Index - Parent
Time frame: Baseline and Week 8.
Attention Network Task - Incongruent Reaction Time
Time frame: Baseline and Week 8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention-Deficit/Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EMS 7500 Digital Muscle Stimulator in people with Attention-Deficit/Hyperactivity Disorder, 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 5 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 11 Apr 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2016). 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: Baseline and Week 8.). 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 11 Apr 2016.