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12 Month Open Extension of TNS for ADHD.

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ClinicalTrials.gov Identifier: NCT03888391
Recruitment Status : Completed
First Posted : March 25, 2019
Results First Posted : April 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder (ADHD)
Intervention Device: Active TNS
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active TNS
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 18
Completed 3
Not Completed 15
Reason Not Completed
Lost to Follow-up             15
Arm/Group Title Active TNS
Hide Arm/Group Description

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:

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
10.41  (1.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
3
  16.7%
Not Hispanic or Latino
15
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  11.1%
White
12
  66.7%
More than one race
2
  11.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
ADHD-Rating Scale Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale.
Number Analyzed 18 participants
16.56  (8.72)
[1]
Measure Description: A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
Clinical Global Impression - Severity (CGI-S)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
1 (Normal, not at all ill)
0
   0.0%
2 (Borderline ill)
0
   0.0%
3 (Mildly ill)
2
  11.1%
4 (Moderately ill)
8
  44.4%
5 (Markedly ill)
8
  44.4%
6 (Severely ill)
0
   0.0%
7 (Among the most extremely ill)
0
   0.0%
[1]
Measure Description: A categorical measure of severity ranging from 1 ("Normal, not at all ill") to 7 ("Among the most seriously ill).
1.Primary Outcome
Title ADHD-IV Rating Scale (ADHD-RS)
Hide Description A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline Number Analyzed 18 participants
19.06  (1.78)
Month 3 Number Analyzed 18 participants
16.56  (1.78)
Month 6 Number Analyzed 8 participants
17.51  (2.45)
Month 9 Number Analyzed 7 participants
15.55  (2.76)
Month 12 Number Analyzed 3 participants
15.97  (3.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .20
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 1.72, df = 1/34
2.Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I)
Hide Description 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."
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 18 participants
Improved
16
  88.9%
Not Improved
2
  11.1%
Month 6 Number Analyzed 8 participants
Improved
8
 100.0%
Not Improved
0
   0.0%
Month 9 Number Analyzed 7 participants
Improved
7
 100.0%
Not Improved
0
   0.0%
Month 12 Number Analyzed 3 participants
Improved
3
 100.0%
Not Improved
0
   0.0%
3.Secondary Outcome
Title Height
Hide Description A dimensional measure assessed in cm.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: cm.
Baseline Number Analyzed 18 participants
140.45  (2.12)
Month 3 Number Analyzed 18 participants
143.09  (2.11)
Month 6 Number Analyzed 8 participants
144.20  (2.25)
Month 9 Number Analyzed 7 participants
147.27  (2.32)
Month 12 Number Analyzed 3 participants
148.37  (2.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 44.47, df = 1/33
4.Secondary Outcome
Title Weight
Hide Description A dimensional measure assessed in kg.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: kg.
Baseline Number Analyzed 18 participants
38.42  (3.20)
Month 3 Number Analyzed 18 participants
38.76  (3.20)
Month 6 Number Analyzed 8 participants
39.37  (3.22)
Month 9 Number Analyzed 7 participants
39.96  (3.23)
Moth 12 Number Analyzed 3 participants
41.82  (3.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 15.74, df = 1/34
5.Secondary Outcome
Title Systolic Blood Pressure
Hide Description A dimensional measure assessed in mm Hg.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 18 participants
109.06  (2.47)
Month 3 Number Analyzed 18 participants
108.72  (2.47)
Month 6 Number Analyzed 8 participants
110.06  (3.50)
Month 9 Number Analyzed 7 participants
109.79  (3.97)
Month 12 Number Analyzed 3 participants
102.18  (5.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .60
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = .28, df = 1/34
6.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description A dimensional measure assessed in mm Hg.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 18 participants
61.89  (2.10)
Month 3 Number Analyzed 18 participants
64.33  (2.10)
Month 6 Number Analyzed 8 participants
63.49  (3.01)
Month 9 Number Analyzed 7 participants
64.40  (3.42)
Month 12 Number Analyzed 3 participants
66.40  (4.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .32
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 1.04, df = 1/34
7.Secondary Outcome
Title Pulse
Hide Description A dimensional measure assessed in heart beats per minute.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were lost to follow up over time.
Arm/Group Title Active TNS
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: Heart beats per minute.
Baseline Number Analyzed 18 participants
81.56  (2.82)
Month 3 Number Analyzed 18 participants
80.78  (2.82)
Month 6 Number Analyzed 8 participants
76.83  (3.64)
Month 9 Number Analyzed 7 participants
79.76  (4.02)
Month 12 Number Analyzed 3 participants
77.25  (5.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed model with time as a predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .27
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 1.27, df = 1/34
8.Other Pre-specified Outcome
Title Conners Global Index - Parent Report
Hide Description Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Conner Global Index - Teacher Report
Hide Description Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Affective Reactivity Index (ARI-C) Child
Hide Description A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Affective Reactivity Index (ARI-P) Parent
Hide Description A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Children's Sleep Habits Questionnaire (CSHQ)
Hide Description 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.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Multidimensional Anxiety Scale for Children (MASC) Child Report
Hide Description A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Multidimensional Anxiety Scale for Children (MASC) Parent Report
Hide Description A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Children's Depression Rating Scale - Revised (CDRS-R)
Hide Description 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.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Behavior Rating Inventory of Executive Functioning (BRIEF)
Hide Description 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.
Time Frame Change over baseline, Month 3, Month 6, Month 9, Month 12
Outcome Measure Data Not Reported
Time Frame 1 year, measured at 3, 6, 9, and 12 months.
Adverse Event Reporting Description Adverse events were solicited via a structured side effects questionnaire and open inquiry, completed at each study visit.
 
Arm/Group Title Active TNS
Hide Arm/Group Description 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.
All-Cause Mortality
Active TNS
Affected / at Risk (%)
Total   0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active TNS
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active TNS
Affected / at Risk (%) # Events
Total   11/18 (61.11%)    
Gastrointestinal disorders   
Stomachache   3/18 (16.67%)  3
Constipation   2/18 (11.11%)  2
Diarrhea   1/18 (5.56%)  1
General disorders   
Drowsy   2/18 (11.11%)  2
Increased appetite   1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Muscle twitching   1/18 (5.56%)  1
Clenching teeth   1/18 (5.56%)  1
Nervous system disorders   
Difficulty finding words   1/18 (5.56%)  1
Psychiatric disorders   
Trouble sleeping   3/18 (16.67%)  5
Hyperactive   6/18 (33.33%)  9
Apathy   1/18 (5.56%)  1
Active suicidal ideation with plan and intent  [1]  0/18 (0.00%)  0
Active suicidal ideation with some intent  [1]  0/18 (0.00%)  0
Active suicidal ideation without intent  [1]  0/18 (0.00%)  0
Renal and urinary disorders   
Frequent urination   2/18 (11.11%)  3
Skin and subcutaneous tissue disorders   
Bruising   1/18 (5.56%)  1
Indicates events were collected by systematic assessment
[1]
Based on the Columbia - Suicide Severity Rating Scale (C-SSRS)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James McGough, M.D.
Organization: University of California, Los Angeles
Phone: 310-794-7841
EMail: jmcgough@mednet.ucla.edu
Layout table for additonal information
Responsible Party: James McGough, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03888391     History of Changes
Other Study ID Numbers: NIMH R34 MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2019
First Posted: March 25, 2019
Results First Submitted: April 3, 2019
Results First Posted: April 29, 2019
Last Update Posted: May 29, 2019