Trial Outcomes & Findings for Four-week Open-trial Extension TNS for ADHD (NCT NCT03870737)

NCT ID: NCT03870737

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Change over Baseline, Week 2, Week 4.
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Four-week Open-trial Extension TNS for ADHD

Baseline characteristics by cohort

Measure	Active TNS n=22 Participants 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.
Age, Continuous	10.39 years STANDARD_DEVIATION 1.45 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants
ADHD-Rating Scale Total Score	20.91 score a scale STANDARD_DEVIATION 8.76 • n=5 Participants
Clinical Global Impression - Severity 3 (Mildly ill)	2 Participants n=5 Participants
Clinical Global Impression - Severity 4 (Moderately ill)	4 Participants n=5 Participants
Clinical Global Impression - Severity 5 (Markedly ill)	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change over Baseline, Week 2, Week 4.

Population: Some participants lost to follow up.

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=22 Participants 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.
ADHD-IV Rating Scale (ADHD-RS) Baseline	28.50 score on a scale Standard Error 1.74
ADHD-IV Rating Scale (ADHD-RS) Week 2	20.91 score on a scale Standard Error 1.74
ADHD-IV Rating Scale (ADHD-RS) Week 4	18.63 score on a scale Standard Error 1.85

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

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=22 Participants 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.
Clinical Global Impression - Improvement (CGI-I) Week 2 · Improved	11 Participants
Clinical Global Impression - Improvement (CGI-I) Week 2 · Not Improved	11 Participants
Clinical Global Impression - Improvement (CGI-I) Week 4 · Improved	12 Participants
Clinical Global Impression - Improvement (CGI-I) Week 4 · Not Improved	8 Participants

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

A dimensional measure assessed in cm.

Outcome measures

Measure	Active TNS n=22 Participants 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.
Height Baseline	140.19 cm. Standard Error 2.02
Height Week 2	140.49 cm. Standard Error 2.02
Height Week 4	140.92 cm. Standard Error 2.02

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

A dimensional measure assessed in kg.

Outcome measures

Measure	Active TNS n=22 Participants 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.
Weight Baseline	34.19 kg. Standard Error 1.53
Weight Week 2	34.61 kg. Standard Error 1.53
Weight Week 3	34.91 kg. Standard Error 1.53

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

A dimensional measure assessed in mm HG.

Outcome measures

Measure	Active TNS n=22 Participants 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.
Systolic Blood Pressure Baseline	107.27 mm Hg. Standard Error 2.22
Systolic Blood Pressure Week 2	109.83 mm Hg. Standard Error 2.30
Systolic Blood Pressure Week 4	107.78 mm Hg. Standard Error 2.30

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

A dimensional measure assessed in mm HG.

Outcome measures

Measure	Active TNS n=22 Participants 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.
Diastolic Blood Pressure Baseline	59.41 mm Hg. Standard Error 1.91
Diastolic Blood Pressure Week 2	58.36 mm Hg. Standard Error 1.99
Diastolic Blood Pressure Week 4	60.51 mm Hg. Standard Error 1.99

SECONDARY outcome

Timeframe: Change over Baseline, Week 2, Week 4

Population: Some participants lost to follow up.

A dimensional measure assessed in heart beats per minute.

Outcome measures

Measure	Active TNS n=22 Participants 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.
Pulse Baseline	75.81 heart beats per minute. Standard Error 2.76
Pulse Week 2	77.04 heart beats per minute. Standard Error 2.81
Pulse Week 4	76.11 heart beats per minute. Standard Error 2.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Change over Baseline and weekly for 4-week trial

Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change over Baseline and weekly for 4-week trial

Teacher 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, Week 4

A 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, Week 4

A 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 and weekly for 4-week trial

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change over Baseline and Week 4

A 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 and Week 4

A parent-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 and Week 4

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change over Baseline and weekly during 4-week trial

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and weekly during 4-week trial

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.

Outcome measures

Outcome data not reported

Adverse Events

Active TNS

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active TNS n=22 participants at risk 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.
Gastrointestinal disorders Stomachache	9.1% 2/22 • Number of events 2 • 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
Gastrointestinal disorders Constipation	13.6% 3/22 • Number of events 5 • 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
Ear and labyrinth disorders Trouble hearing	4.5% 1/22 • Number of events 1 • 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
Musculoskeletal and connective tissue disorders Muscle twitching	4.5% 1/22 • Number of events 1 • 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
Respiratory, thoracic and mediastinal disorders Stuffy nose	22.7% 5/22 • Number of events 6 • 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
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • 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
General disorders Drowsy	9.1% 2/22 • Number of events 3 • 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
General disorders Fatigue	4.5% 1/22 • Number of events 1 • 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
Psychiatric disorders Trouble sleeping	9.1% 2/22 • Number of events 3 • 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
Psychiatric disorders Nightmares	4.5% 1/22 • Number of events 1 • 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
Psychiatric disorders Hyperactive	36.4% 8/22 • Number of events 13 • 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
Psychiatric disorders Feels strange	4.5% 1/22 • Number of events 1 • 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
Nervous system disorders Difficulty finding words	4.5% 1/22 • Number of events 1 • 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
Psychiatric disorders Apathy	9.1% 2/22 • Number of events 2 • 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
Psychiatric disorders Suicidal ideation with active plan and intent	0.00% 0/22 • 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
Psychiatric disorders Suicidal ideation with some intent	0.00% 0/22 • 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
Psychiatric disorders Active suicidal ideation without intent	0.00% 0/22 • 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

Additional Information

James J. McGough, M.D.

University of California, Los Angeles

Phone: 310-794-7841

Email: jmcgough@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place