Post by healthy11 on Feb 9, 2021 13:43:08 GMT -5
The following was posted on attentionresearchupdate@helpforadd.com by David Rabiner,PhD of Duke University:
Trigeminal nerve stimulation - A non-drug ADHD treatment while children sleep
Although medication treatment for ADHD has substantial research support and remains the most widely used ADHD treatment, not all children benefit, some experience intolerable side effects, and many parents remain reluctant to employ this treatment for there child. For these reasons, developing effective alternatives to medication treatment remains important..
Trigeminal nerve stimulation (TNS) is a non-invasive treatment approach that was recently cleared by the FDA as a treatment for pediatric ADHD. This treatment approach was developed by Neuorsigma.
TNS treatment occurs while the child is sleeping and is overseen by parents/caregivers. It uses a cell-phone sized device that generates low-level electrical pulses and connects via a wire to a small patch on the child's forehead, The system delivers low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. Some children experience a mild tingling sensation that generally fades over time. While the exact mechanism(s) by which TNS yields effects is not fully known, neuroimaging studies suggest that it increases activity in brain regions known to be important in regulating attention, emotion and behavior.
Randomized-controlled trial of TNS for ADHD - Study participants were 62 8-to 12-year old children with ADHD (roughly 60% males) who were medication free for at least 1 month prior to the trial. They were randomly assigned to receive actual or sham TNS treatment over a 4-week period.
Parents were instructed on administering treatment which was provided each night while children slept. The active and sham systems appeared identical and neither parents, children, or clinicians were aware of which condition the child was assigned to.
To maintain the 'blind', participants were informed that “pulses may come so fast or so slowly that the nerves in the forehead might or might not detect a sensation.” There was no difference between parents or children in each group in their expectations of treatment benefit, and thus no indication that participants were aware of their treatment assignment.
Measures - The primary efficacy outcome measure was the ADHD-RS total score. On the ADHD-RS, all 18 DSM-V symptom of ADHD are rated for their frequency of occurrence using a 1 (never/rarely) to 4 (very often); high scores thus reflect more frequent and persistent symptoms.
Study clinicians completed the ADHD-RS was completed at baseline and after each week of treatment based on parental interview and all available clinical information; it was completed a final time one-week after treatment was discontinued.
In addition to this primary outcome measure, clinicians completed the Clinical Global Impressions Scale, a 6-point scale used to provide an overall assessment of improvement that range from Very much improved to Much worse. Children rated Very much improved or Much improved were considered to have improved.
Teachers also rated children's behavior each week using the Conners Global Index, a measure used to obtain teachers' assessment of a youth's behavior in the school setting.
To examine whether TNS treatment was linked to change in children's brainwave activity, EEG data was also collected before and after treatment.
Results - For the ADHD-RS, a significant decline in ADHD symptom ratings from baseline to the end of the first week occurred in both groups. Declines in ADHD symptoms continued over the remaining 3 weeks for children receiving active treatment, however, but leveled off in the sham treatment group.
As a result of the ongoing decline associated with active treatment, after 4 weeks, group differences in ADHD symptom ratings were in the moderate range. The benefits associated with active treatment were roughly comparable in size to what has been found for non-stimulant medications.
In addition, 52% of the active group were rated as improved on the CGI compared to only 14% who received sham treatment. There were no group differences, however, on the teacher behavior ratings.
EEG data indicated higher levels of activation in particular brain regions for children receiving active treatment. Furthermore, changes in activation were correlated with a reduction in ADHD symptoms, specifically hyperactive-impulsive symptoms.
Measures collected one week after discontinuing treatment showed increases in symptom ratings for both groups. And, the percent of children receiving active treatment who were still rated as improved relative to baseline declined from 52% after week 4 to 13% .
Safety and tolerability - Some adverse events were reported, but these were judged to be of minimal clinical significance. Reports of headache and fatigue were associated with active TNS treatment, but no child left the study because of side effects. There were small but statistically significant increases in weight and appetite in the active group that require ongoing investigation in longer studies.
Summary and implications - Results from this study indicate that TNS is a promising treatment for children with ADHD. In this blinded, placebo-controlled study, treatment was associated with a moderate reduction in core ADHD symptoms, an effect below what is typically reported for stimulant medication but roughly comparable to non-stimulant medication treatments.
It was also the case that over 50% of children receiving treatment were rated as either Very much improved or much improved after 4 weeks. While this is encouraging, it also means that roughly half of treated children did not receive this benefit.
A number of important questions remain to be addressed in additional research, including the following:
Would more extended treatment result in continued improvement and greater treatment gains?
Because treatment benefits dissipated after treatment was discontinued, are there any adverse affects associated with more extended treatment?
There was no evidence that teachers observed treatment benefits. Demonstrating that this treatment has benefits that carry over into the school setting will be important.
It will be interesting to learn the answers to these questions - and others - in subsequent research. As with any treatment study, it will also be important to replicate these positive effects in an independent sample.
Currently, the treatment is cleared only for children not taking ADHD medication, and its safety and efficacy in combination with medication treatment is not yet known.
This treatment was recently made available by Neurosigma and must be access through a physician. Information is available at www.monarch-etns.com/
Trigeminal nerve stimulation - A non-drug ADHD treatment while children sleep
Although medication treatment for ADHD has substantial research support and remains the most widely used ADHD treatment, not all children benefit, some experience intolerable side effects, and many parents remain reluctant to employ this treatment for there child. For these reasons, developing effective alternatives to medication treatment remains important..
Trigeminal nerve stimulation (TNS) is a non-invasive treatment approach that was recently cleared by the FDA as a treatment for pediatric ADHD. This treatment approach was developed by Neuorsigma.
TNS treatment occurs while the child is sleeping and is overseen by parents/caregivers. It uses a cell-phone sized device that generates low-level electrical pulses and connects via a wire to a small patch on the child's forehead, The system delivers low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. Some children experience a mild tingling sensation that generally fades over time. While the exact mechanism(s) by which TNS yields effects is not fully known, neuroimaging studies suggest that it increases activity in brain regions known to be important in regulating attention, emotion and behavior.
Randomized-controlled trial of TNS for ADHD - Study participants were 62 8-to 12-year old children with ADHD (roughly 60% males) who were medication free for at least 1 month prior to the trial. They were randomly assigned to receive actual or sham TNS treatment over a 4-week period.
Parents were instructed on administering treatment which was provided each night while children slept. The active and sham systems appeared identical and neither parents, children, or clinicians were aware of which condition the child was assigned to.
To maintain the 'blind', participants were informed that “pulses may come so fast or so slowly that the nerves in the forehead might or might not detect a sensation.” There was no difference between parents or children in each group in their expectations of treatment benefit, and thus no indication that participants were aware of their treatment assignment.
Measures - The primary efficacy outcome measure was the ADHD-RS total score. On the ADHD-RS, all 18 DSM-V symptom of ADHD are rated for their frequency of occurrence using a 1 (never/rarely) to 4 (very often); high scores thus reflect more frequent and persistent symptoms.
Study clinicians completed the ADHD-RS was completed at baseline and after each week of treatment based on parental interview and all available clinical information; it was completed a final time one-week after treatment was discontinued.
In addition to this primary outcome measure, clinicians completed the Clinical Global Impressions Scale, a 6-point scale used to provide an overall assessment of improvement that range from Very much improved to Much worse. Children rated Very much improved or Much improved were considered to have improved.
Teachers also rated children's behavior each week using the Conners Global Index, a measure used to obtain teachers' assessment of a youth's behavior in the school setting.
To examine whether TNS treatment was linked to change in children's brainwave activity, EEG data was also collected before and after treatment.
Results - For the ADHD-RS, a significant decline in ADHD symptom ratings from baseline to the end of the first week occurred in both groups. Declines in ADHD symptoms continued over the remaining 3 weeks for children receiving active treatment, however, but leveled off in the sham treatment group.
As a result of the ongoing decline associated with active treatment, after 4 weeks, group differences in ADHD symptom ratings were in the moderate range. The benefits associated with active treatment were roughly comparable in size to what has been found for non-stimulant medications.
In addition, 52% of the active group were rated as improved on the CGI compared to only 14% who received sham treatment. There were no group differences, however, on the teacher behavior ratings.
EEG data indicated higher levels of activation in particular brain regions for children receiving active treatment. Furthermore, changes in activation were correlated with a reduction in ADHD symptoms, specifically hyperactive-impulsive symptoms.
Measures collected one week after discontinuing treatment showed increases in symptom ratings for both groups. And, the percent of children receiving active treatment who were still rated as improved relative to baseline declined from 52% after week 4 to 13% .
Safety and tolerability - Some adverse events were reported, but these were judged to be of minimal clinical significance. Reports of headache and fatigue were associated with active TNS treatment, but no child left the study because of side effects. There were small but statistically significant increases in weight and appetite in the active group that require ongoing investigation in longer studies.
Summary and implications - Results from this study indicate that TNS is a promising treatment for children with ADHD. In this blinded, placebo-controlled study, treatment was associated with a moderate reduction in core ADHD symptoms, an effect below what is typically reported for stimulant medication but roughly comparable to non-stimulant medication treatments.
It was also the case that over 50% of children receiving treatment were rated as either Very much improved or much improved after 4 weeks. While this is encouraging, it also means that roughly half of treated children did not receive this benefit.
A number of important questions remain to be addressed in additional research, including the following:
Would more extended treatment result in continued improvement and greater treatment gains?
Because treatment benefits dissipated after treatment was discontinued, are there any adverse affects associated with more extended treatment?
There was no evidence that teachers observed treatment benefits. Demonstrating that this treatment has benefits that carry over into the school setting will be important.
It will be interesting to learn the answers to these questions - and others - in subsequent research. As with any treatment study, it will also be important to replicate these positive effects in an independent sample.
Currently, the treatment is cleared only for children not taking ADHD medication, and its safety and efficacy in combination with medication treatment is not yet known.
This treatment was recently made available by Neurosigma and must be access through a physician. Information is available at www.monarch-etns.com/