Trial Outcomes & Findings for Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01388530)
NCT ID: NCT01388530
Last Updated: 2016-04-11
Results Overview
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
COMPLETED
EARLY_PHASE1
25 participants
Baseline and Week 8.
2016-04-11
Participant Flow
Recruitment was initiated in July 2011 and ended in October 2012. Participants self-identified or were referred from community providers in response to public advertisements.
Following informed permission/assent participants were assessed for eligibility and if meeting inclusion/exclusion criteria initiated 8 weeks of open-label Trigeminal Nerve Stimulation (TNS) treatment.
Participant milestones
| Measure |
Trigeminal Nerve Stimulation
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Trigeminal Nerve Stimulation
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Trigeminal Nerve Stimulation
n=25 Participants
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.14 years
STANDARD_DEVIATION 1.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8.Population: Participants with data at baseline and week 4. We included participants who participated in 4 weeks of treatment, but change comparison is baseline vs. week 8.
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
Outcome measures
| Measure |
Trigeminal Nerve Stimulation
n=22 Participants
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
ADHD-IV Rating Scale (ADHD-RS)
|
32.6 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Week 8Population: Participants with data at baseline and week 4. As with the ADHD-RS, we included participants with at least 4 weeks of treatment, but outcome was assessed at Visit 8 compared with baseline.
A global measure of clinical improvement compared with baseline. A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse). Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others.
Outcome measures
| Measure |
Trigeminal Nerve Stimulation
n=22 Participants
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Clinical Global Impression - Improvement (CGI-I)
|
67 percentage of improved
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Participants with data at baseline and week 4. We required 4 weeks treatment to include in analysis, but analysis is based on comparison of baseline and week 8.
A standard, parent completed measure of ADHD symptoms. Scale range from 0 (best) to 27 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8).
Outcome measures
| Measure |
Trigeminal Nerve Stimulation
n=22 Participants
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Conners Global Index - Parent
|
19.6 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Participants with data at baseline and week 4. We included participants who completed 4 weeks of treatment, but comparison is based on Week 8 vs. baseline.
Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network. Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome.
Outcome measures
| Measure |
Trigeminal Nerve Stimulation
n=22 Participants
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
|
|---|---|
|
Attention Network Task - Incongruent Reaction Time
|
902.9 milliseconds (ms).
Standard Deviation 31.2
|
Adverse Events
Trigeminal Nerve Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James McGough, M.D.
David Geffen School of Medicine at UCLA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place