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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH101282 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.
Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase.
Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TNS | Experimental | Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TNS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Conners Global Index - Parent Report | Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Conner Global Index - Teacher Report |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James J. McGough, M.D. | University of California, Los Angelesr | Principal Investigator |
| Sandra K. Loo, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TNS | Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TNS | Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial. Active TNS: |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants lost to follow up over time. | Posted | Least Squares Mean | Standard Error | score on a scale | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
1 year, measured at 3, 6, 9, and 12 months.
Adverse events were solicited via a structured side effects questionnaire and open inquiry, completed at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TNS | Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trouble sleeping | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James McGough, M.D. | University of California, Los Angeles | 310-794-7841 | jmcgough@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2015 | Mar 20, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2018 | Apr 3, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Open-label active treatment
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| Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Height | A dimensional measure assessed in cm. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Weight | A dimensional measure assessed in kg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Systolic Blood Pressure | A dimensional measure assessed in mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Diastolic Blood Pressure | A dimensional measure assessed in mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Pulse | A dimensional measure assessed in heart beats per minute. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms. |
| Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Affective Reactivity Index (ARI-C) Child | A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Affective Reactivity Index (ARI-P) Parent | A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Children's Sleep Habits Questionnaire (CSHQ) | A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99, divided among 8 sub scales, with higher scores indicating more severe difficulties. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| 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. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Multidimensional Anxiety Scale for Children (MASC) Parent Report | A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Children's Depression Rating Scale - Revised (CDRS-R) | A clinician completed dimensional measure of child mood symptoms, obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <=28 define remission. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| Behavior Rating Inventory of Executive Functioning (BRIEF) | A parent completed rating of executive functioning. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores for each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ADHD-Rating Scale Total Score | A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity. | Mean | Standard Deviation | score on a scale. |
|
| Clinical Global Impression - Severity (CGI-S) | A categorical measure of severity ranging from 1 ("Normal, not at all ill") to 7 ("Among the most seriously ill). | Count of Participants | Participants |
|
|
|
|
| Secondary | 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." | Some participants lost to follow up over time. | Posted | Count of Participants | Participants | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
| Secondary | Height | A dimensional measure assessed in cm. | Some participants lost to follow up over time. | Posted | Least Squares Mean | Standard Error | cm. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
|
| Secondary | Weight | A dimensional measure assessed in kg. | Some participants lost to follow up over time. | Posted | Least Squares Mean | Standard Error | kg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
|
| Secondary | Systolic Blood Pressure | A dimensional measure assessed in mm Hg. | Some participants lost to follow up over time. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
|
| Secondary | Diastolic Blood Pressure | A dimensional measure assessed in mm Hg. | Some participants lost to follow up over time. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
|
| Secondary | Pulse | A dimensional measure assessed in heart beats per minute. | Some participants were lost to follow up over time. | Posted | Least Squares Mean | Standard Error | Heart beats per minute. | Change over baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
|
|
| Other Pre-specified | Conners Global Index - Parent Report | Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Conner Global Index - Teacher Report | Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Affective Reactivity Index (ARI-C) Child | A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Affective Reactivity Index (ARI-P) Parent | A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Children's Sleep Habits Questionnaire (CSHQ) | A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99, divided among 8 sub scales, with higher scores indicating more severe difficulties. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | 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. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Multidimensional Anxiety Scale for Children (MASC) Parent Report | A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Children's Depression Rating Scale - Revised (CDRS-R) | A clinician completed dimensional measure of child mood symptoms, obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <=28 define remission. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| Other Pre-specified | Behavior Rating Inventory of Executive Functioning (BRIEF) | A parent completed rating of executive functioning. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores for each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Not Posted | Change over baseline, Month 3, Month 6, Month 9, Month 12 | Participants |
| 0 |
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| 0 |
| 18 |
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| Drowsy | General disorders | Systematic Assessment |
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| Hyperactive | Psychiatric disorders | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Frequent urination | Renal and urinary disorders | Systematic Assessment |
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| Increased appetite | General disorders | Systematic Assessment |
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| Difficulty finding words | Nervous system disorders | Systematic Assessment |
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| Apathy | Psychiatric disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Clenching teeth | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Active suicidal ideation with plan and intent | Psychiatric disorders | Systematic Assessment | Based on the Columbia - Suicide Severity Rating Scale (C-SSRS) |
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| Active suicidal ideation with some intent | Psychiatric disorders | Systematic Assessment | Based on the Columbia - Suicide Severity Rating Scale (C-SSRS) |
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| Active suicidal ideation without intent | Psychiatric disorders | Systematic Assessment | Based on the Columbia - Suicide Severity Rating Scale (C-SSRS) |
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