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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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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TNS | Device | Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study. |
|
| 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, Week 2, Week 4. |
| 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 score range from 0- 30, and higher scores indicating more severe symptoms. | Change over Baseline and weekly for 4-week trial |
| Conners Global Index - Teacher Report |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James J. McGough, M.D. | University of California, Los Angeles | 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 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. Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TNS | 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. Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study. |
| Units | Counts |
|---|---|
| Participants |
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| 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. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | score on a scale | Change over Baseline, Week 2, Week 4. |
|
Data were collected over the 4-week open trial, beginning at baseline and then at weeks 2 and 4.
Adverse events were solicited via a structured side effects questionnaire and open inquiry completed at each assessment point
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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 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. Active TNS: Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James J. 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 8, 2019 | ICF_001.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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| Change over Baseline, Week 2, Week 4 |
| Height | A dimensional measure assessed in cm. | Change over Baseline, Week 2, Week 4 |
| Weight | A dimensional measure assessed in kg. | Change over Baseline, Week 2, Week 4 |
| Systolic Blood Pressure | A dimensional measure assessed in mm HG. | Change over Baseline, Week 2, Week 4 |
| Diastolic Blood Pressure | A dimensional measure assessed in mm HG. | Change over Baseline, Week 2, Week 4 |
| Pulse | A dimensional measure assessed in heart beats per minute. | Change over Baseline, Week 2, Week 4 |
Teacher completed dimensional rating of ADHD symptoms,with scores ranging from 0-30, and higher scores indicating more severe symptoms. |
| Change over Baseline and weekly for 4-week trial |
| 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, Week 4 |
| 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, Week 4 |
| 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 and weekly for 4-week trial |
| 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 and Week 4 |
| 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. | Change over Baseline and Week 4 |
| Children's Depression Rating Scale - Revised (CDRS-R) | A clinician-completed dimensional measure of childhood 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 defines remission. | Change over Baseline and Week 4 |
| Behavior Rating Inventor of Executive Functioning (BRIEF) | A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Change over Baseline and weekly during 4-week trial |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | standard instrument to assess potential suicidality with dichotomous scores (0 = absent; 1 = present) to rate various components of suicidal ideation and behavior. Data derived are summarized under Adverse Event Reporting. | Baseline and weekly during 4-week trial |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 a scale |
|
| Clinical Global Impression - Severity | A categorical measure of severity ranging from 1 ("Normal, not at all ill") to 7 (Among the most seriously ill). | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | Posted | Count of Participants | Participants | Change over Baseline, Week 2, Week 4 |
|
|
|
| Secondary | Height | A dimensional measure assessed in cm. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | cm. | Change over Baseline, Week 2, Week 4 |
|
|
|
|
| Secondary | Weight | A dimensional measure assessed in kg. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | kg. | Change over Baseline, Week 2, Week 4 |
|
|
|
|
| Secondary | Systolic Blood Pressure | A dimensional measure assessed in mm HG. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over Baseline, Week 2, Week 4 |
|
|
|
|
| Secondary | Diastolic Blood Pressure | A dimensional measure assessed in mm HG. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over Baseline, Week 2, Week 4 |
|
|
|
|
| Secondary | Pulse | A dimensional measure assessed in heart beats per minute. | Some participants lost to follow up. | Posted | Least Squares Mean | Standard Error | heart beats per minute. | Change over Baseline, Week 2, Week 4 |
|
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|
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| Other Pre-specified | Conners Global Index - Parent Report | Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms. | Not Posted | Change over Baseline and weekly for 4-week trial | Participants |
| Other Pre-specified | Conners 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 and weekly for 4-week trial | 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, Week 4 | 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, Week 4 | 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 and weekly for 4-week trial | 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 and Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Change over Baseline and Week 4 | Participants |
| Other Pre-specified | Children's Depression Rating Scale - Revised (CDRS-R) | A clinician-completed dimensional measure of childhood 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 defines remission. | Not Posted | Change over Baseline and Week 4 | Participants |
| Other Pre-specified | Behavior Rating Inventor of Executive Functioning (BRIEF) | A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Not Posted | Change over Baseline and weekly during 4-week trial | Participants |
| Other Pre-specified | Columbia-Suicide Severity Rating Scale (C-SSRS) | standard instrument to assess potential suicidality with dichotomous scores (0 = absent; 1 = present) to rate various components of suicidal ideation and behavior. Data derived are summarized under Adverse Event Reporting. | Not Posted | Baseline and weekly during 4-week trial | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 14 |
| 22 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Trouble hearing | Ear and labyrinth disorders | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stuffy nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Drowsy | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Trouble sleeping | Psychiatric disorders | Systematic Assessment |
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| Nightmares | Psychiatric disorders | Systematic Assessment |
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| Hyperactive | Psychiatric disorders | Systematic Assessment |
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| Feels strange | Psychiatric 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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| Suicidal ideation with active plan and intent | Psychiatric disorders | Systematic Assessment | Based on the Columbia Suicide Severity Rating Scale (C-SSRS) |
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| 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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