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neurostimulation

The European Society for Brain Stimulation opposes EU reclassification of TMS and tDCS, claiming a flawed safety assessment

January 24, 2023 by SharpBrains Leave a Comment

Man­i­festo: Oppo­si­tion to EU Reclas­si­fi­ca­tion of TMS and tDCS equip­ment to Class III devices based on flawed evi­dence (Euro­pean Soci­ety for Brain Stimulation):

It has recent­ly come to our atten­tion that the EU has reclas­si­fied the NIBS equip­ments includ­ing rTMS and tDCS, as Class III devices, the cat­e­go­ry of high­est risk, sim­i­lar to inva­sive treat­ments, such as deep-brain stim­u­la­tion implants. This reclas­si­fi­ca­tion has a major impact on our field, not only for man­u­fac­tur­ers, but also for researchers, clin­i­cians and patients and we judge this reclas­si­fi­ca­tion a mis­take. First, the evi­den­tial basis for this change is a flawed assess­ment of the safe­ty lit­er­a­ture. Sec­ond, the con­sul­ta­tion process has occurred with­out input from spe­cial­ists or stake­hold­ers pro­fes­sion­al­ly active in the field of NIBS. Nei­ther the ESBS nor Nation­al Soci­eties of Brain Stim­u­la­tion nor indi­vid­ual experts with­in the Euro­pean NIBS com­mu­ni­ty were con­sult­ed on this change. [Read more…] about The Euro­pean Soci­ety for Brain Stim­u­la­tion oppos­es EU reclas­si­fi­ca­tion of TMS and tDCS, claim­ing a flawed safe­ty assessment

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: brain stimulation, EU, European Society for Brain Stimulation, neurostimulation, rTMS, tDCS

Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer’s Disease applications

January 14, 2021 by SharpBrains

Cred­it: The Picow­er Insti­tute @ MIT

Cog­ni­to Ther­a­peu­tics nets FDA break­through label for light, sound ther­a­py for Alzheimer’s dis­ease (Fierce Biotech):

Using spe­cif­ic fre­quen­cies of flash­ing lights and sounds to stim­u­late the brain’s elec­tri­cal activ­i­ty, Cog­ni­to Ther­a­peu­tics believes it can help treat Alzheimer’s dis­ease by ener­giz­ing neu­rons and reac­ti­vat­ing the immune system.

[Read more…] about Neu­rostim­u­la­tion device Gam­maSense by Cog­ni­to Ther­a­peu­tics secures FDA Break­through Device Des­ig­na­tion to explore Alzheimer’s Dis­ease applications

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: amyloid plaques, breakthrough device, breakthrough therapy, cognitive-symptoms, Cognito Therapeutics, digital therapeutics, FDA, GammaSense, hippocampus, neurodegenerative-diseases, neuromodulation, Neurons, neurostimulation, Neurotechnology, treat Alzheimer’s disease

Update: Moderate lifetime drinking may lead to lower Alzheimer-related beta amyloid deposits in the brain

April 24, 2020 by SharpBrains

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Time for a new edi­tion of Sharp­Brains’ e‑newsletter.

#1. First of all, it’s not all bad news this month. Study finds that mod­er­ate life­time drink­ing may lead to low­er Alzheimer-relat­ed beta amy­loid deposits in the brain

#2. And, talk about per­son­al­ized med­i­cine! This fas­ci­nat­ing study show­ing how brain imag­ing (fMRI) + machine learn­ing + inten­sive, non-inva­sive neu­rostim­u­la­tion = tar­get­ed treat­ments that can max­i­mize effi­ca­cy and min­i­mize side effects: Rein­vent­ing depres­sion treat­ment via tran­scra­nial mag­net­ic brain stim­u­la­tion (TMS)

#3. Also, not a minute too soon … Med­i­ta­tion apps have gone main­stream in the covid-19 era and Dig­i­tal health start-ups raised a record $3.1 bil­lion in Q1; focus will like­ly evolve from providers to con­sumers and employers

#4. Fyi, a very time­ly vir­tu­al event com­ing Tues­day April 28th, online: Explore strate­gies and tools to boost men­tal well­be­ing dur­ing (and after) Covid-19

#5. Now, “While Pear has an advan­tage over the com­pe­ti­tion in that its prod­ucts are backed by ran­dom­ized clin­i­cal tri­als, physi­cians and health plans are still work­ing out how to pre­scribe and pay for dig­i­tal ther­a­peu­tics.” The FDA clears Som­ryst, Pear’s dig­i­tal ther­a­peu­tic to treat chron­ic insomnia

#6. Net net, now is the time for indi­vid­ual and col­lec­tive action to shift to a health­i­er “new nor­mal” for all: 3 ways to pro­tect your men­tal health dur­ing –and after– COVID-19 (in Span­ish: Tres hábitos de higiene men­tal para vencer al COVID-19 y crear un futuro más salud­able). Want more? Enjoy these Three tips for wise minds to calm coro­n­avirus anxiety

#7. A small but impor­tant study for that hope­ful near future when uni­ver­si­ties and col­leges reopen their doors: Study finds mixed results of Adder­all as cog­ni­tive enhancer (seems to boost emo­tion more than cognition)

#8. But, first things first. “The Bee Gees song “Stayin’ Alive” reached #1 on the pop charts in 1977. Maybe it was the beat, maybe it was John Travolta’s danc­ing. Or maybe it’s that the Gibb broth­ers’ cen­tral lyric is quite lit­er­al­ly always play­ing in our head. Keep­ing us safe —that is, “stayin’ alive ”— is the pri­ma­ry mis­sion of the brain”

  • Explor­ing the human brain and how it responds to stress (1/3)
  • On World Health Day 2020, let’s dis­cuss the stress response and the Gen­er­al Adap­ta­tion Syn­drome (2/3)
  • The frontal lobes, the lit­tle brain down under and “Stayin’ Alive” (3/3)

Enough with coro­n­avirus out­break. Any­thing else going on? Yes!

#9. The Right to Per­son­al Iden­ti­ty. The Right to Free Will. The Right to Men­tal Pri­va­cy. The Right to Equal Access to Men­tal Aug­men­ta­tion. The Right to Pro­tec­tion from Algo­rith­mic Bias. Will these five Neu­roR­ights help har­ness emerg­ing neu­rotech­nolo­gies for the com­mon good?

#10. “Today, the sci­en­tif­ic inves­ti­ga­tion of tran­scen­dent expe­ri­ences is, in my view, one of the most excit­ing fron­tiers in the sci­ence of well-being.” Tran­scend­ing Maslow’s famous “hier­ar­chy of needs” through Maslow’s own research on Peak Experiences

#11. You CAN have your cake and eat it too: Here’s a brain teas­er to stim­u­late your men­tal imagery, spa­tial rota­tion … and appetite

#12. Ques­tion: My first thought after con­grat­u­lat­ing myself on being so clever about some­thing? Tease your brain with these eight fun rid­dles…

 

Wish­ing you and yours a great month of May,

 

The Sharp­Brains Team

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Filed Under: Attention & ADD/ADHD, Brain Teasers, Brain/ Mental Health, Education & Lifelong Learning, Technology & Innovation Tagged With: Adderall, Alzheimer-disease, Alzheimers-disease, beta-amyloid, brain, brain teaser for adults, Brain Teasers, Brain-Imaging, brain-teaser, cognitive-enhancer, depression, digital health, digital therapeutics, meditation apps, mental health, neurorights, neurostimulation, personalized-medicine, riddles, Stress, Transcend

Halo Neuroscience raises $13M to further develop and commercialize neuromodulation headset aimed at inducing “hyperplasticity”

February 2, 2018 by SharpBrains

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Halo Neu­ro­science rais­es $13m in Series B (Mass Device):

“Neu­rostim­u­la­tion device mak­er Halo Neu­ro­science said today it raised $13 mil­lion in a Series B round of financ­ing to sup­port its Halo Sport neu­rostim head­set designed to improve mus­cle mem­o­ry acqui­si­tion from ath­let­ic train­ing. [Read more…] about Halo Neu­ro­science rais­es $13M to fur­ther devel­op and com­mer­cial­ize neu­ro­mod­u­la­tion head­set aimed at induc­ing “hyper­plas­tic­i­ty”

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Filed Under: Brain/ Mental Health, Peak Performance, Technology & Innovation Tagged With: Halo Neuroscience, Halo Sport, headset, hyperplasticity, neuromodulation, neuropriming, neurostimulation

Two Alvaros leading brain health @ BrainFutures 2017

September 7, 2017 by SharpBrains

– Álvaro Fer­nán­dez Ibáñez (left) and Álvaro Pas­cual-Leone (right), speak­ing yes­ter­day at Brain­Fu­tures 2017

Keynot­ing a fan­tas­tic con­fer­ence, Álvaro Pas­cual-Leone pre­sent­ed an overview of Neu­ro­mod­u­la­tion and Neu­rostim­u­la­tion, and Álvaro Fer­nán­dez Ibáñez dis­cussed the future of Brain Health and Enhance­ment build­ing on the slid­edeck below.

Excit­ing times!

The Future of Brain Health and Enhance­ment from Sharp­Brains

Hun­dreds of sci­ence labs and com­pa­nies around the globe are research­ing and devel­op­ing new ways to help brain own­ers be smarter, sharp­er and health­i­er. What explains this flur­ry of activ­i­ty, and where may it be head­ed? Which com­pa­nies, tech­nolo­gies and solu­tions are gain­ing the most trac­tion so far, and what are some of the best prac­tices for appro­pri­ate use?

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: brain-enhancement, Brain-health, neuromodulation, neurostimulation

Eight research teams working with DARPA to discover best ways to activate neuroplasticity and accelerate learning

May 12, 2017 by SharpBrains

DARPA Funds Brain-Stim­u­la­tion Research to Speed Learn­ing (DoD news):

“The Defense Advanced Research Projects Agency is work­ing with sev­en U.S. uni­ver­si­ties and ele­ments of the Air Force and Army on research that seeks to stim­u­late the brain in a non-inva­sive way to speed up learning.

DARPA announced the Tar­get­ed Neu­ro­plas­tic­i­ty Train­ing, or TNT, pro­gram [Read more…] about Eight research teams work­ing with DARPA to dis­cov­er best ways to acti­vate neu­ro­plas­tic­i­ty and accel­er­ate learning

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Filed Under: Education & Lifelong Learning, Peak Performance, Technology & Innovation Tagged With: Brain-Plasticity, cognitive skills training, cognitive-skills, Cognitive-Training, DARPA, Learning, neuromodulation, neuroplasticity, neurostimulation, synaptic-plasticity, Targeted Neuroplasticity Training, training

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