FDA

On cognitive-physical training, brain biomarkers, dementia, ketamine, brain teasers, riddles and more

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Wel­come to the last 2022 edi­tion of Sharp­Brains e‑newsletter, fea­tur­ing a few select­ed brain health news and fun teasers to chal­lenge your brain and help us all think out­side the box.

#1. “Every­one agrees that Google Glass failed when it came to mar­ket, but to me, it’s a sym­bol of hope … It inspired peo­ple to think beyond tra­di­tion­al ways of mov­ing about our envi­ron­ment. Instead of look­ing down at a device, we could look out at the world and have an over­lay of dig­i­tal infor­ma­tion. It was one of the first steps in physical–digital con­ver­gence that we are see­ing today through­out many indus­tries. And as some­one who has cre­at­ed many inven­tions that nev­er left the lab or were too ear­ly for the mar­ket, I love the fact that Glass came out at all!” — wise words by neu­rotech entre­pre­neur Dr. Cori Lath­an in her new (and excel­lent) book. See Tech­nol­o­gy as a bridge in time: Shap­ing the future of brain health via today’s innovations–including those that “fail”

#2. “Some peo­ple want to do cog­ni­tive train­ing while mov­ing rather than sit­ting down, and that real­ly spoke to me as a pos­si­bil­i­ty for real ben­e­fits giv­en anec­do­tal sto­ries about games like ‘Dance Dance Rev­o­lu­tion.’” — Joaquin A. Anguera, asso­ciate pro­fes­sor at UCSF and direc­tor of Neuroscape‘s Clin­i­cal Divi­sion. See Study: A com­bined cog­ni­tive-phys­i­cal train­ing approach may enhance both mind and body as we age

#3. “Giv­en that ketamine’s rapid action and unex­pect­ed dis­so­cia­tive effects make it a poten­tial­ly worth­while option for treat­ing men­tal health prob­lems, we are on a mis­sion to unpack this mys­tery, at the cross­roads between phar­ma­col­o­gy and neu­ro­science.” See Study iden­ti­fies cog­ni­tive ben­e­fits of ket­a­mine in patients with treat­ment-resis­tant depression

#4. “The grat­i­tude writ­ing group main­tained grat­i­tude lev­els and decreased stress and neg­a­tive affect at one-month post-inter­ven­tion” — that main­te­nance aspect is espe­cial­ly inter­est­ing. See Thanks­giv­ing works: Grat­i­tude jour­nal­ing seen to low­er stress and neg­a­tive cog­ni­tive processes

#5. Impres­sive new funding–especially giv­en mar­ket conditions–with a goal to iden­ti­fy “brain bio­mark­ers by ana­lyz­ing EEG activ­i­ty, behav­ioral task per­for­mance, wear­able data, genet­ics, and oth­er fac­tors to match each patient with the right Alto drug.” See Pre­ci­sion psy­chi­a­try pio­neer Alto Neu­ro­science rais­es $35M to advance dig­i­tal bio­mark­er-to-treat­ment platform

#6. Some bad news. See The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

#7. And some great news: “(Péter Hudomi­et, study’s lead author) said it’s also pos­si­ble that, giv­en numer­ous stud­ies being released on steps to take to avoid demen­tia, some of the decline may be attrib­uted to peo­ple heed­ing such advice.” See Study finds sharp decrease (near­ly one-third) in the preva­lence of demen­tia among those 65+ in the Unit­ed States

#8. Final­ly, here are a few brain teasers to stim­u­late those neu­rons in your tem­po­ral lobes and to help us all think out­side the box.

 

Have a healthy and won­der­ful 2023!

 

The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

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FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus):

The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency ear­ly on that it lacked the legal author­i­ty to ful­ly imple­ment pathway.

In 2017, the FDA pro­posed the idea of a Pre-Cert pro­gram that would act as a new path­way for soft­ware as a med­ical device (SaMD) prod­ucts, through which the agency could green-light such prod­ucts based on how much reg­u­la­tors trust the man­u­fac­tur­er. The agency has been run­ning a pilot pro­gram to test the fea­si­bil­i­ty of the pro­gram, but in a new report, FDA con­cedes it does not have the legal author­i­ty need­ed to cre­ate the pro­gram as orig­i­nal­ly envi­sioned. [Read more…] about The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

Update: Playing videogames may be more cognitively beneficial than other forms of screentime like social media, watching videos/ TV

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news and a fun brain teas­er to put your tem­po­ral lobes to good use 🙂

#1. Study finds that play­ing videogames may be more cog­ni­tive­ly ben­e­fi­cial for chil­dren than oth­er forms of screen­time (social media, watch­ing videos/ TV)

“Here, we esti­mat­ed the impact of dif­fer­ent types of screen time (watch­ing, social­iz­ing, or gam­ing) on children’s intel­li­gence while con­trol­ling for the con­found­ing effects of genet­ic dif­fer­ences in cog­ni­tion and socioe­co­nom­ic sta­tus … Broad­ly, our results are in line with research on the mal­leabil­i­ty of cog­ni­tive abil­i­ties from envi­ron­men­tal fac­tors, such as cog­ni­tive train­ing and the Fly­nn effect.”

Fas­ci­nat­ing! Hav­ing said that…

#2. Large neu­roimag­ing study finds social iso­la­tion to be an ear­ly indi­ca­tor of increased demen­tia risk

“Social inter­ac­tion is huge­ly impor­tant. One study found that the size of our social group is actu­al­ly asso­ci­at­ed with the vol­ume of the orbitofrontal cor­tex (involved in social cog­ni­tion and emo­tion). But how many friends do we need? … It is hard to argue with the fact that humans are social ani­mals and gain enjoy­ment from con­nect­ing with oth­ers, what­ev­er age we are. But, as we are increas­ing­ly uncov­er­ing, it also cru­cial for the health of our cognition.”

#3. UC study finds near-trans­fer of cog­ni­tive train­ing to be nec­es­sary (yet not suf­fi­cient) for far-trans­fer, broad­er benefits

“Some peo­ple do very well in train­ing, such as play­ing a video game, but they don’t show near trans­fer, per­haps because they are using high­ly spe­cif­ic strate­gies,” said first author Anja Pahor … “For these peo­ple, far trans­fer is unlike­ly. By bet­ter under­stand­ing why this type of mem­o­ry train­ing or ‘inter­ven­tion’ works for some peo­ple but not oth­ers, we can move for­ward with a new gen­er­a­tion of work­ing-mem­o­ry train­ing games or use approach­es that are more tai­lored to indi­vid­u­als’ needs”

#4. Please help us recruit 30,000 adults for a UC Cit­i­zen Sci­ence project on cog­ni­tive training

“In our ongo­ing large-scale study (note: the one right above) we aim to recruit 30,000 adults who are moti­vat­ed and will­ing to help us bet­ter under­stand the fac­tors that under­lie learn­ing out­comes using a vari­ety of train­ing par­a­digms and out­come mea­sures. Our endeav­or will ulti­mate­ly con­tribute to the per­son­al­iza­tion of cog­ni­tive train­ing so that, hope­ful­ly, any­one who would like to improve their cog­ni­tive func­tion­ing will be able to choose the approach that may fit them best.” — researchers Susanne Jaeg­gi, Anja Pahor, Aaron Seitz @ UC Irvine/ Riverside

#5. Trend: Esports teams har­ness cog­ni­tive tests to bet­ter match play­er to task and to iden­ti­fy train­ing opportunities

Esports are bor­row­ing a page from Pro Sports’ book … we would­n’t be sur­prised to see the inverse tak­ing place too in just a few years.

#6. Dos and Don’ts of Ther­a­py on the Go: Nav­i­gat­ing the use of apps for men­tal health care

“For those with­out severe men­tal ill­ness, app-based ther­a­py may be help­ful in match­ing clients with a pro­fes­sion­al famil­iar with a range of prob­lems and stres­sors. This makes apps attrac­tive to those with anx­i­ety and mild to mod­er­ate depres­sion. They also appeal to peo­ple who wouldn’t ordi­nar­i­ly seek out office-based ther­a­py, but who want help with life issues such as mar­i­tal prob­lems and work-relat­ed stress.”

#7. AI-enabled chat­bot Wysa receives FDA Break­through Device des­ig­na­tion for patients with chron­ic pain, depres­sion and anxiety

Let’s talk!

#8. And here’s the Brain Teas­er: Ready to stim­u­late those neu­rons in your tem­po­ral lobes?

 

Wish­ing you and yours a healthy and fun summer!

AI-enabled chatbot Wysa receives FDA Breakthrough Device designation for patients with chronic pain, depression and anxiety

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AI Behav­ior Health Chat­bot App Fast-Tracked by FDA (Psy­chol­o­gy Today):

Recent­ly the U.S. Food and Drug Admin­is­tra­tion (FDA) grant­ed break­through device des­ig­na­tion to Wysa’s AI-based dig­i­tal men­tal health con­ver­sa­tion­al agent that deliv­ers cog­ni­tive behav­ioral ther­a­py (CBT) via a smart­phone to adults suf­fer­ing from depres­sion, anx­i­ety, and chron­ic mus­cu­loskele­tal pain [Read more…] about AI-enabled chat­bot Wysa receives FDA Break­through Device des­ig­na­tion for patients with chron­ic pain, depres­sion and anxiety

“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

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The effi­ca­cy of Men­tal Health Apps (phar­mafo­rum):

In Jan­u­ary, PLOS Dig­i­tal Health pub­lished a study which claimed that there’s “sparse” data to sup­port the effi­ca­cy of most men­tal health apps.

In their meta-analy­sis of pub­lished stud­ies, the authors found uni­ver­sal defi­cien­cies and con­clud­ed that there’s no con­vinc­ing evi­dence that app-based inter­ven­tions deliv­er mean­ing­ful out­comes. With­out dig­ging fur­ther, one might think the cur­rent case for dig­i­tal ther­a­peu­tics is weak.

I reviewed all 14 meta-analy­ses includ­ed in the study and found the analy­sis to be accu­rate, but incom­plete. [Read more…] about “Dig­i­tal ther­a­peu­tics” vs. “Men­tal health apps”: A grow­ing debate on stan­dards, reg­u­la­tion and efficacy

From “Eminence-based” to Evidence-based cognitive & mental healthcare: Time for quality and accountability

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news, two excel­lent new books and a few fun brain teasers.

#1. From “Emi­nence-based” to Evi­dence-based men­tal health­care: Time to focus on qual­i­ty and accountability

“The real chal­lenge is not find­ing a ther­a­pist, it’s find­ing a ther­a­pist who knows how to pro­vide the treat­ments that work. In the ear­ly 2000s, Myr­na Weiss­man was try­ing to under­stand why so few ther­a­pists use sci­en­tif­i­cal­ly based treat­ments. She found that over 60 per­cent of pro­fes­sion­al schools of psy­chol­o­gy and master’s lev­el social work pro­grams did not include any super­vised train­ing for any sci­en­tif­i­cal­ly based ther­a­py … In con­trast to evi­dence-based care, I call this “emi­nence-based care.” — Dr. Thomas Insel in his excel­lent new book

#2. Anoth­er great new book to cel­e­brate Brain Aware­ness Week 2022

“Spain played a unique role in Cajal’s discoveries—that is, in the pro­gres­sion of neu­ro­science. The coun­try was not a hotbed of sci­en­tif­ic research. Lack­ing men­tors, Cajal near­ly aban­doned his efforts. But work­ing inde­pen­dent­ly may have forged his auton­o­my and freed him from the influ­ence of tra­di­tion­al the­o­ries. He also longed to dis­prove the stereo­types about Spain. “One could admit that Spain pro­duces some genius artist, such as a long-haired poet or ges­tic­u­lat­ing dancer of either sex,” Cajal lat­er wrote, “but the idea that a true man of sci­ence would emerge from there was con­sid­ered absurd.” — Fas­ci­nat­ing insights into the “father of mod­ern neuroscience”

#3. UT-Dal­las Brain­Health presents vir­tu­al talks with Alvaro Fer­nan­dez and San­jay Gup­ta next month (April 21th and 26th; both 8:00 – 9:00 PM EDT/ Mia­mi time)

We believe some of you may be interested 🙂

#4. Cana­di­an study finds causal link between time play­ing videogames at age 12 and ADHD symp­toms at age 13

“After con­trol­ling for sex, socioe­co­nom­ic sta­tus, and ADHD symp­toms at age 12, the week­ly amount video game play report­ed at age 12 pre­dict­ed high­er lev­els of self-report­ed ADHD symp­toms at age 13 … The mag­ni­tude of the effect was not large, but it was sta­tis­ti­cal­ly sig­nif­i­cant. In con­trast, high­er lev­els of ADHD symp­toms at age 12 did not pre­dict an increase in video game play one year later.”

#5. From for­est bathing to urban parks: How nature helps pro­tect our well-being dur­ing a pandemic

“Whether we gar­den, have a view of nature out our win­dow, vis­it near­by parks, or even just watch a nature video, we can help our­selves deal with the stress­es and strains of COVID iso­la­tion by giv­ing our­selves and our kids a dose of “Vit­a­min N.”

#6. A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health

Good to see rec­og­nized the need for “reim­burse­ment inno­va­tion” for emerg­ing dig­i­tal bio­mark­ers & ther­a­peu­tics — the FDA does have both sticks and car­rots to leverage

#7. New DARPA ini­tia­tive aims to har­ness cog­ni­tive sci­ence, sen­sors and machine learn­ing to detect ear­ly brain signs of depres­sion, anx­i­ety, and sui­ci­dal ideation

“NEAT is a proof-of-con­cept effort attempt­ing to devel­op a new tool for men­tal and behav­ioral health screen­ing that moves us beyond his­tor­i­cal and cur­rent meth­ods of ques­tions and con­scious­ly fil­tered respons­es … If suc­cess­ful, NEAT will not only sig­nif­i­cant­ly aug­ment behav­ioral health screen­ing, but it could also serve as a new way to assess ulti­mate treat­ment effi­ca­cy, since patients will often tell their clin­i­cians what they think the clin­i­cian wants to hear rather than how they are tru­ly feel­ing.” — Greg Witkop, pro­gram man­ag­er in DARPA’s Defense Sci­ences Office

#8. Sep­a­rat­ing brain-healthy wheat from chaff is becom­ing more urgent by the day

Would you trust claims in A or B or neither?

Final­ly, here’s a selec­tion of fun brain teasers that read­ers have enjoyed the most this year so far:

#9. Where’s the baby?

#10. Can you con­nect these pairs of words?

#11. Want to test your stress level?

#12. Which way is the bus head­ing?

 

Wish­ing you and yours a healthy and stim­u­lat­ing April … and let’s get some Vit­a­min N (and D) this weekend!

The Sharp­Brains Team