Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
Interventions
DEVICEEMS 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.
Sponsors
NeuroSigma, Inc.
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview * minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S * Clinical Global Impression- Severity (CGI-S) score at baseline * no current medications with central nervous system (CNS) affects * parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.
Exclusion criteria
* impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression. * history of lifetime psychosis or mania * current suicidality * history of seizure disorder, tic disorder, or head injury with loss of consciousness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD-IV Rating Scale (ADHD-RS) | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Improvement (CGI-I) | Week 8 | 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. |
| Conners Global Index - Parent | 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). |
| Attention Network Task - Incongruent Reaction Time | Baseline and Week 8. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Trigeminal Nerve Stimulation |
|---|---|
| Age, Categorical <=18 years | 25 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.14 years STANDARD_DEVIATION 1.98 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
ADHD-IV Rating Scale (ADHD-RS)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trigeminal Nerve Stimulation | ADHD-IV Rating Scale (ADHD-RS) | 32.6 units on a scale | Standard Deviation 1.58 |
Secondary
Attention Network Task - Incongruent Reaction Time
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trigeminal Nerve Stimulation | Attention Network Task - Incongruent Reaction Time | 902.9 milliseconds (ms). | Standard Deviation 31.2 |
Secondary
Clinical Global Impression - Improvement (CGI-I)
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trigeminal Nerve Stimulation | Clinical Global Impression - Improvement (CGI-I) | 67 percentage of improved |
Secondary
Conners Global Index - Parent
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trigeminal Nerve Stimulation | Conners Global Index - Parent | 19.6 units on a scale | Standard Deviation 1.3 |