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Four-week Open-trial Extension TNS for ADHD

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ClinicalTrials.gov Identifier: NCT03870737
Recruitment Status : Completed
First Posted : March 12, 2019
Results First Posted : April 26, 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 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active TNS
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 22
Completed 20
Not Completed 2
Arm/Group Title Active TNS
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
10.39  (1.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
5
  22.7%
Male
17
  77.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
3
  13.6%
Not Hispanic or Latino
19
  86.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
17
  77.3%
More than one race
3
  13.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
ADHD-Rating Scale Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score a scale
Number Analyzed 22 participants
20.91  (8.76)
[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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
3 (Mildly ill)
2
   9.1%
4 (Moderately ill)
4
  18.2%
5 (Markedly ill)
16
  72.7%
[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, Week 2, Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Baseline Number Analyzed 22 participants
28.50  (1.74)
Week 2 Number Analyzed 22 participants
20.91  (1.74)
Week 4 Number Analyzed 20 participants
18.63  (1.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcomes fitted via a mixed effects model with time as 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 = 24.81, df = 1/40.
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, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2 Number Analyzed 22 participants
Improved
11
  50.0%
Not Improved
11
  50.0%
Week 4 Number Analyzed 20 participants
Improved
12
  60.0%
Not Improved
8
  40.0%
3.Secondary Outcome
Title Height
Hide Description A dimensional measure assessed in cm.
Time Frame Change over Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: cm.
Baseline Number Analyzed 22 participants
140.19  (2.02)
Week 2 Number Analyzed 22 participants
140.49  (2.02)
Week 4 Number Analyzed 20 participants
140.92  (2.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcome was fitted using a mixed model with time as predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 5.78, df = 1/39.
4.Secondary Outcome
Title Weight
Hide Description A dimensional measure assessed in kg.
Time Frame Change over Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: kg.
Baseline Number Analyzed 22 participants
34.19  (1.53)
Week 2 Number Analyzed 22 participants
34.61  (1.53)
Week 3 Number Analyzed 20 participants
34.91  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcome was fitted using a mixed model with time as predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = 14.28, df = 1/39.
5.Secondary Outcome
Title Systolic Blood Pressure
Hide Description A dimensional measure assessed in mm HG.
Time Frame Change over Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 22 participants
107.27  (2.22)
Week 2 Number Analyzed 22 participants
109.83  (2.30)
Week 4 Number Analyzed 20 participants
107.78  (2.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcome was fitted using a mixed model with time as predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .67
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = .19, df = 1/39.
6.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description A dimensional measure assessed in mm HG.
Time Frame Change over Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg.
Baseline Number Analyzed 22 participants
59.41  (1.91)
Week 2 Number Analyzed 22 participants
58.36  (1.99)
Week 4 Number Analyzed 20 participants
60.51  (1.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcome was fitted using a mixed model with time as predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .76
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = .08, df = 1/39.
7.Secondary Outcome
Title Pulse
Hide Description A dimensional measure assessed in heart beats per minute.
Time Frame Change over Baseline, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants lost to follow up.
Arm/Group Title Active TNS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: heart beats per minute.
Baseline Number Analyzed 22 participants
75.81  (2.76)
Week 2 Number Analyzed 22 participants
77.04  (2.81)
Week 4 Number Analyzed 20 participants
76.11  (2.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TNS
Comments Outcome was fitted using a mixed model with time as predictor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .80
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time: F = .06, df = 1/39.
8.Other Pre-specified Outcome
Title Conners Global Index - Parent Report
Hide Description Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms.
Time Frame Change over Baseline and weekly for 4-week trial
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Conners 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 and weekly for 4-week trial
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, Week 4
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, Week 4
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 and weekly for 4-week trial
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 and Week 4
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Multidimensional Anxiety Scale for Children (MASC) - Parent Report
Hide Description A parent-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Time Frame Change over Baseline and Week 4
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 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.
Time Frame Change over Baseline and Week 4
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Behavior Rating Inventor of Executive Functioning (BRIEF)
Hide Description 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.
Time Frame Change over Baseline and weekly during 4-week trial
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description 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.
Time Frame Baseline and weekly during 4-week trial
Outcome Measure Data Not Reported
Time Frame Data were collected over the 4-week open trial, beginning at baseline and then at weeks 2 and 4.
Adverse Event Reporting Description Adverse events were solicited via a structured side effects questionnaire and open inquiry completed at each assessment point
 
Arm/Group Title Active TNS
Hide Arm/Group Description

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.

All-Cause Mortality
Active TNS
Affected / at Risk (%)
Total   0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active TNS
Affected / at Risk (%) # Events
Total   0/22 (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   14/22 (63.64%)    
Ear and labyrinth disorders   
Trouble hearing   1/22 (4.55%)  1
Gastrointestinal disorders   
Stomachache   2/22 (9.09%)  2
Constipation   3/22 (13.64%)  5
General disorders   
Drowsy   2/22 (9.09%)  3
Fatigue   1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Muscle twitching   1/22 (4.55%)  1
Nervous system disorders   
Headache   1/22 (4.55%)  1
Difficulty finding words   1/22 (4.55%)  1
Psychiatric disorders   
Trouble sleeping   2/22 (9.09%)  3
Nightmares   1/22 (4.55%)  1
Hyperactive   8/22 (36.36%)  13
Feels strange   1/22 (4.55%)  1
Apathy   2/22 (9.09%)  2
Suicidal ideation with active plan and intent  [1]  0/22 (0.00%)  0
Suicidal ideation with some intent  [1]  0/22 (0.00%)  0
Active suicidal ideation without intent  [1]  0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders   
Stuffy nose   5/22 (22.73%)  6
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 J. 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: NCT03870737     History of Changes
Other Study ID Numbers: NIH R34MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2019
First Posted: March 12, 2019
Results First Submitted: April 3, 2019
Results First Posted: April 26, 2019
Last Update Posted: May 29, 2019