Trial Outcomes & Findings for 12 Month Open Extension of TNS for ADHD. (NCT NCT03888391)
NCT ID: NCT03888391
Last Updated: 2019-05-29
Results Overview
A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
COMPLETED
NA
18 participants
Change over baseline, Month 3, Month 6, Month 9, Month 12
2019-05-29
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
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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Overall Study
Lost to Follow-up
|
15
|
Baseline Characteristics
12 Month Open Extension of TNS for ADHD.
Baseline characteristics by cohort
| Measure |
Active TNS
n=18 Participants
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:
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|---|---|
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Age, Continuous
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10.41 years
STANDARD_DEVIATION 1.32 • n=39 Participants
|
|
Sex: Female, Male
Female
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3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=39 Participants
|
|
ADHD-Rating Scale Total Score
|
16.56 score on a scale.
STANDARD_DEVIATION 8.72 • n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
1 (Normal, not at all ill)
|
0 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
2 (Borderline ill)
|
0 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
3 (Mildly ill)
|
2 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
4 (Moderately ill)
|
8 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
5 (Markedly ill)
|
8 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
6 (Severely ill)
|
0 Participants
n=39 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
7 (Among the most extremely ill)
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Participants lost to follow up over time.
A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
ADHD-IV Rating Scale (ADHD-RS)
Baseline
|
19.06 score on a scale
Standard Error 1.78
|
|
ADHD-IV Rating Scale (ADHD-RS)
Month 3
|
16.56 score on a scale
Standard Error 1.78
|
|
ADHD-IV Rating Scale (ADHD-RS)
Month 6
|
17.51 score on a scale
Standard Error 2.45
|
|
ADHD-IV Rating Scale (ADHD-RS)
Month 9
|
15.55 score on a scale
Standard Error 2.76
|
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ADHD-IV Rating Scale (ADHD-RS)
Month 12
|
15.97 score on a scale
Standard Error 3.72
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SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants lost to follow up over time.
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."
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
Clinical Global Impression - Improvement (CGI-I)
Month 3 · Improved
|
16 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 3 · Not Improved
|
2 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 6 · Improved
|
8 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 6 · Not Improved
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 9 · Improved
|
7 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 9 · Not Improved
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 12 · Improved
|
3 Participants
|
|
Clinical Global Impression - Improvement (CGI-I)
Month 12 · Not Improved
|
0 Participants
|
SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants lost to follow up over time.
A dimensional measure assessed in cm.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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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Height
Baseline
|
140.45 cm.
Standard Error 2.12
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Height
Month 3
|
143.09 cm.
Standard Error 2.11
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Height
Month 6
|
144.20 cm.
Standard Error 2.25
|
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Height
Month 9
|
147.27 cm.
Standard Error 2.32
|
|
Height
Month 12
|
148.37 cm.
Standard Error 2.56
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SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants lost to follow up over time.
A dimensional measure assessed in kg.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
Weight
Baseline
|
38.42 kg.
Standard Error 3.20
|
|
Weight
Month 3
|
38.76 kg.
Standard Error 3.20
|
|
Weight
Month 6
|
39.37 kg.
Standard Error 3.22
|
|
Weight
Month 9
|
39.96 kg.
Standard Error 3.23
|
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Weight
Moth 12
|
41.82 kg.
Standard Error 3.28
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SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants lost to follow up over time.
A dimensional measure assessed in mm Hg.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
Systolic Blood Pressure
Baseline
|
109.06 mm Hg.
Standard Error 2.47
|
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Systolic Blood Pressure
Month 3
|
108.72 mm Hg.
Standard Error 2.47
|
|
Systolic Blood Pressure
Month 6
|
110.06 mm Hg.
Standard Error 3.50
|
|
Systolic Blood Pressure
Month 9
|
109.79 mm Hg.
Standard Error 3.97
|
|
Systolic Blood Pressure
Month 12
|
102.18 mm Hg.
Standard Error 5.42
|
SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants lost to follow up over time.
A dimensional measure assessed in mm Hg.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
Diastolic Blood Pressure
Month 6
|
63.49 mm Hg.
Standard Error 3.01
|
|
Diastolic Blood Pressure
Month 9
|
64.40 mm Hg.
Standard Error 3.42
|
|
Diastolic Blood Pressure
Month 12
|
66.40 mm Hg.
Standard Error 4.70
|
|
Diastolic Blood Pressure
Baseline
|
61.89 mm Hg.
Standard Error 2.10
|
|
Diastolic Blood Pressure
Month 3
|
64.33 mm Hg.
Standard Error 2.10
|
SECONDARY outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Population: Some participants were lost to follow up over time.
A dimensional measure assessed in heart beats per minute.
Outcome measures
| Measure |
Active TNS
n=18 Participants
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.
|
|---|---|
|
Pulse
Baseline
|
81.56 Heart beats per minute.
Standard Error 2.82
|
|
Pulse
Month 3
|
80.78 Heart beats per minute.
Standard Error 2.82
|
|
Pulse
Month 6
|
76.83 Heart beats per minute.
Standard Error 3.64
|
|
Pulse
Month 9
|
79.76 Heart beats per minute.
Standard Error 4.02
|
|
Pulse
Month 12
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77.25 Heart beats per minute.
Standard Error 5.23
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OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over baseline, Month 3, Month 6, Month 9, Month 12A 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.
Outcome measures
Outcome data not reported
Adverse Events
Active TNS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TNS
n=18 participants at risk
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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|---|---|
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Psychiatric disorders
Trouble sleeping
|
16.7%
3/18 • Number of events 5 • 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.
|
|
General disorders
Drowsy
|
11.1%
2/18 • Number of events 2 • 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.
|
|
Psychiatric disorders
Hyperactive
|
33.3%
6/18 • Number of events 9 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Stomachache
|
16.7%
3/18 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Frequent urination
|
11.1%
2/18 • Number of events 3 • 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.
|
|
General disorders
Increased appetite
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Nervous system disorders
Difficulty finding words
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Psychiatric disorders
Apathy
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Clenching teeth
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Psychiatric disorders
Active suicidal ideation with plan and intent
|
0.00%
0/18 • 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.
|
|
Psychiatric disorders
Active suicidal ideation with some intent
|
0.00%
0/18 • 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.
|
|
Psychiatric disorders
Active suicidal ideation without intent
|
0.00%
0/18 • 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.
|
Additional Information
James McGough, M.D.
University of California, Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place