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FDA clears Trigeminal nerve stimulation (TNS) as ADHD treatment


Although stim­u­lant med­ica­tions are gen­er­al­ly con­sid­ered to be a safe and effec­tive treat­ment for ADHD, not all chil­dren ben­e­fit from this approach. Many par­ents are reluc­tant to begin their child on med­ica­tion and some chil­dren expe­ri­ence unac­cept­able side affects.

For these rea­sons, devel­op­ing safe and effec­tive alter­na­tive treat­ments for ADHD remains a pri­or­i­ty. Trigem­i­nal nerve stim­u­la­tion (TNS) is an alter­na­tive approach that was recent­ly test­ed in a dou­ble-blind, sham-con­trolled study.

The Study:

TNS is a non­in­va­sive, min­in­mal-risk neu­ro­mod­u­la­tion pro­ce­dure that has been pre­vi­ous­ly approved in Cana­da and Europe to treat adults with med­ica­tion-resis­tant depres­sion and epilep­sy.

The trigem­i­nal nerve con­veys sen­so­ry inputs to regions of the brain that under­ly the main­te­nance of atten­tion. Indi­vid­u­als under­go­ing TNS treat­ment wear a small stim­u­la­tor dur­ing sleep that emits a low-lev­el cur­rent to stim­u­late the trigem­i­nal nerve. This is hypoth­e­sized to increase acti­va­tion in par­tic­u­lar brain regions relat­ed to ADHD symp­toms such that those symp­toms are reduced.

TNS was test­ed in this study with 62 8- to-12-year old youth diag­nosed with ADHD; rough­ly two-thirds were male and none were on med­ica­tion dur­ing the study.

Par­tic­i­pants were ran­dom­ly assigned to receive 4 weeks of active TNS, or a sham treat­ment, dur­ing sleep. Chil­dren in the sham treat­ment wore the same device dur­ing sleep but their trigem­i­nal nerve was not stim­u­lat­ed.

The study was intro­duced to chil­dren and par­ents so that the like­li­hood of being able to know for cer­tain whether active or sham treat­ment was being pro­vid­ed was min­i­mized. And, in fact, data col­lect­ed dur­ing the study indi­cat­ed that par­tic­i­pants were not bet­ter than chance at know­ing which group they were in.

The pri­ma­ry out­come mea­sure was a clin­i­cian-com­plet­ed rat­ing of ADHD symp­toms; the rat­ings were made based on inter­view­ing par­ents and all oth­er avail­able clin­i­cal infor­ma­tion. Rat­ings were com­plet­ed before treat­ment began, after each week of the 4‑week tri­al, and one week after treat­ment had end­ed. Clin­i­cians mak­ing the rat­ings were also blind to whether par­tic­i­pants were receiv­ing active or sham treat­ment.

Oth­er mea­sures includ­ed a quan­ti­ta­tive assess­ment of brain­wave activ­i­ty, i.e., qEEG, col­lect­ed before and after treat­ment. The qEEG data was used to deter­mine whether active treat­ment was asso­ci­at­ed with sig­nif­i­cant changes in brain­wave activ­i­ty. Teach­ers also com­plet­ed rat­ings of chil­dren’s class­room behav­ior.

The Findings:

Dur­ing the 4‑week tri­al, rat­ings of ADHD symp­toms declined sig­nif­i­cant­ly in both groups with sig­nif­i­cant­ly greater declines occur­ring in chil­dren who received active treat­ment.

In both groups, the bulk of the decline occurred in the first week, with a larg­er decline in the active group. Beyond the first week, chil­dren receiv­ing active treat­ment con­tin­ued to show mod­est declines in symp­tom rat­ings while rat­ings in the sham-treat­ment group remained sta­ble.

After 4 weeks, group dif­fer­ences in ADHD symp­toms rat­ings was in the mod­er­ate range, small­er than what is gen­er­al­ly obtained with stim­u­lant med­ica­tions and about the same as what non-stim­u­lant med­ica­tions typ­i­cal­ly pro­duce.

One week after treat­ment end­ed, symp­tom rat­ings had increased in both groups, but remained low­er in chil­dren who had received active treat­ment.

Sig­nif­i­cant dif­fer­ences between active and sham-treat­ment groups were also found on the brain­wave activ­i­ty mea­sure, i.e., qEEG. These dif­fer­ences were con­sis­tent with increased acti­va­tion in a vari­ety of brain regions for treat­ed chil­dren.

Of par­tic­u­lar inter­est was that these acti­va­tion changes were asso­ci­at­ed with changes in ADHD symp­tom rat­ings. This sug­gests, but does not prove, that treat­ment-relat­ed changes in brain­wave activ­i­ty con­tributed to the reduc­tion on ADHD symp­toms.

Treat­ment group dif­fer­ences in behav­ior rat­ings pro­vid­ed by teach­ers was not found.

No adverse effects on TNS were report­ed and it was well tol­er­at­ed by par­tic­i­pants.

Summary and implications:

Results from this study indi­cate that TNS is a promis­ing new treat­ment for chil­dren with ADHD. In terms of its impact on core ADHD symp­toms, it appears to be as effec­tive, on aver­age, as non-stim­u­lant ADHD med­ica­tions but less effec­tive than stim­u­lants.

Based on these results, and per­haps oth­er find­ings, TNS was recent­ly cleared by the FDA as an ADHD treat­ment for chil­dren; it should be com­mer­cial­ly avail­able in sev­er­al months.

For par­ents who may even­tu­al­ly con­sid­er this for their child, sev­er­al items should be not­ed.

First, as not­ed above, avail­able data indi­cates the like­ly impact on core ADHD symp­toms is less than for stim­u­lant med­ica­tion.

Sec­ond, as with med­ica­tion and behav­ioral treat­ment, pos­i­tive effects are like­ly to reverse when treat­ment is dis­con­tin­ued.

Third, this study did not find pos­i­tive results for teacher rat­ings which is an impor­tant lim­i­ta­tion. And, the pos­si­ble impact on aca­d­e­m­ic func­tion­ing was not assessed. Thus, evi­dence that TNS improves chil­dren’s func­tion­ing at school is lack­ing.

These con­cerns sug­gest that cau­tion is war­rant­ed in using TNS as a stand alone treat­ment for ADHD in chil­dren. Future work should exam­ine whether it pro­vides incre­men­tal ben­e­fits when used in con­junc­tion with med­ica­tion, behav­ior ther­a­py, or oth­er treat­ment approach­es.

It would also be impor­tant to deter­mine whether TNS leads to sig­nif­i­cant improve­ments at school, some­thing that was not found here.

Final­ly, it should be empha­sized that this was a rel­a­tive­ly short tri­al of 4 weeks. Giv­en that chil­dren receiv­ing TNS con­tin­ued to show mod­est declines in ADHD symp­toms dur­ing each week of the tri­al, it is pos­si­ble that addi­tion­al improve­ments would accrue with sus­tained treat­ment.

If so, the pos­si­ble ben­e­fits of this approach may be greater than what was demon­strat­ed in this ini­tial tri­al. Hope­ful­ly, results from longer tri­als of this treat­ment will be avail­able soon.

– Dr. David Rabin­er is a child clin­i­cal psy­chol­o­gist and Direc­tor of Under­grad­u­ate Stud­ies in the Depart­ment of Psy­chol­o­gy and Neu­ro­science at Duke Uni­ver­si­ty. He pub­lish­es the Atten­tion Research Update, an online newslet­ter that helps par­ents, pro­fes­sion­als, and edu­ca­tors keep up with the lat­est research on ADHD.

The Study in Context:

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Categories: Attention and ADD/ADHD, Cognitive Neuroscience, Health & Wellness, Technology

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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