How It Works

THE SCIENCE OF INTELLIHAT® – FREQUENTLY ASKED QUESTIONS

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What exactly is INTELLIHAT® and what does it do?
Intellihat® is a consumer health device designed to slow the effects of cognitive decline due to natural aging. The product is a high-quality baseball cap which contains a built-in battery powered microcomputer and two antennas that deliver a gentle electrical stimulation to targeted areas of the brain.

When a person turns 40 years old, the brain begins to lose “plasticity” or the ability to learn, adapt, and grow. This is because the level of electrical activity needed for neurons in our brain to transmit information increases as we age.  Intellihat® uses a proven medical technology – transcranial direct current stimulation, or tDCS – to reduce the threshold for neuron activation in key areas of our brain related to cognition and behavior.

Is it safe? Is it effective? How easy is it to use? Is it affordable?
These are the questions we always get asked first, and the rest of this FAQ document addresses these and more in greater detail. The short answers are:
• Yes, it is safe – tens of thousands of people have already used tDCS-based products already with no adverse effects.
• Yes, there are hundreds of academic and medical papers published on the effectiveness of tDCS.
• Our goal with Intellihat® was to create a tDCS product to mitigate the effects of age-related cognitive decline that was both simple to use and much less expensive than anything else available.

Read on to get more detail. When appropriate we have also included references to academic and medical papers written by professionals with no ties to our company so you can review the work yourself.

What is unique about the INTELLIHAT®?
Although there are other products that use electromagnetic fields to stimulate the brain and nervous system, our goal with Intellihat® was to create a product to use for helping with cognitive decline. So how did we do this?

First, Intellihat® uses transcranial direct current stimulation, or tDCS – a proven medical technology that at the low levels of current used is extremely safe.

Second, Intellihat® targets a specific area of the brain named the dorsal lateral prefrontal cortex, or DLPFC, that acts as a central clearing house for memory, attention, judgment, social behavior.  (The DLPFC is located just under the skull, a few inches above the outside edge of your eyebrow.)

Third, Intellihat® was designed to be both simple and unobtrusive to use. Other systems require special electrodes and gels, careful placement of electrodes each time, and adjustment of stimulation parameters. Intellihat® works just like a hat – you place it on your head, and it provides thirty minutes of gentle stimulation. In many ways we designed this product not only for us but for our aging parents; we knew it had to be simple to use, as well as attractive to wear, if our parents were going to use it regularly.

What is transcranial direct current stimulation (TDCS) and how does it work?
Transcranial Direct Current Stimulation (tDCS) is a well-known medical technique where a low level electrical field is applied to the brain. “Transcranial” refers to the two electrodes that are placed on the outer surface of the head, and “Direct Current Stimulation” to the use of constant or relatively slowly changing electric fields.

The level of electrical activity needed for neurons in our brain to activate to transmit information increases as we age.  tDCS works by lowering the threshold that neurons in the brain need to activate.  (See References 1-3)

How does tDCS compare to other ways of stimulating the brain?
The medical field of neuromodulation – treating disorders of the brain and nervous system using electromagnetic fields – is already a $7B industry, and approved by the FDA to treat diseases including chronic pain, depression, and Parkinson’s disease. Other methods of neuromodulation, including transcranial magnetic stimulation, are typically expensive and can only be used under the direct supervision of a physician or trained professional. tDCS is relatively inexpensive, and because it is considered safe, can often be purchased and used by people in their own homes.

Is tDCS safe?
According to a recent academic paper that reviewed nearly one hundred fifty other academic studies, “TDCS has been tested in thousands of subjects worldwide with no evidence of toxic effects to date… studies also reported only mild, benign, and transient side effects.”  (See Reference 4)

It is worth noting that the US Food and Drug Administration (FDA) has specific guidelines for tDCS, and that the current levels used in Intellihat® fall well within the range where the FDA does NOT require that a product be submitted to them for prior approval.

However, TDCS should generally not be used without a doctor’s supervision if a person has an unstable medical condition; is under treatment with medications for a serious psychiatric condition such as depression, anxiety, or addiction; has uncontrolled epilepsy; has any metallic implants located near the site where the electrodes will be placed on the scalp. Also, our device should not be used on children or teenagers.

Is tDCS effective?
Numerous studies have been done that show the effectiveness of tDCS in improving cognitive function, including memory, attention, and information processing and decision making.

Several of these studies have been performed on patients with a medical condition that produces noticeable memory loss; in these, tDCS applied to the DLPFC has been shown to increase performance on tests related to memory by as much as 20% or more, with effects lasting for up to four weeks. (See References 5-7)

The idea of using tDCS on healthy individuals is more recent; however there are already a number of studies showing that tDCS stimulation of the DLPFC has a measurable positive impact on working memory, attention, and information processing and decision making. (See References 8-12)

A recent paper that analyzed the results of nineteen separate studies on the use of tDCS  on the DLPFC  said that “When all the results are pooled together, we found that non-invasive brain stimulation of the dorsolateral prefrontal cortex induces working memory improvement in both healthy and clinical sample [populations].” (Reference 13)

Does it only work when I am wearing the device?
No. The direct effects of a tDCS session are measurable up to an hour after wearing the device, and other studies have shown that patients that have had five consecutive daily sessions have benefits that persist for between two and four weeks.  (References 14-19)

Will I feel anything? Are there any side effects?
The majority of people using the device will not feel anything.  Some people may feel either mild tingling or light itching sensations on the scalp when using the device, but this generally subsides after a few minutes of use.  These effects are highly dependent on the individual – we all have different shaped heads, different amounts of hair, and different thicknesses of our skull. dvanced users of the current Intellihat® can try different stimulation waveforms.

Users of other device have occasionally reported moderate fatigue or headaches when using these other tDCS devices.

 

SELECTED REFERENCES

1. Priori A, Berardelli A, Rona S, Accornero N, Manfredi M. Polarization of the human motor cortex through the scalp. Neuroreport. 1998 Jul 13; 9(10):2257–2260. [PubMed: 9694210]
2. Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, et al. Transcranial direct current stimulation: State of the art 2008 BRAIN STIMULATION. 2008; 1(3):206–223.
3. Priori A, Hallett M, Rothwell JC. Repetitive transcranial magnetic stimulation or transcranial direct current stimulation? Brain Stimul. 2009 Oct; 2(4):241–245. [PubMed: 20633424]
4. Brain Stimul. 2012 Jul;5(3):175-95. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F.
5. Patients with Parkinson’s Disease were treated with tDCS, and showed an improvement of over 20% in performance on a working memory task. J Neurol Sci. 2006;249:31–38 Effects of transcranial direct current stimulation on working memory in patients with Parkinson’s disease. Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, et al.
6. Patients with Alzheimers’ Disease were treated with tDCS for five days; patients showed an increase in recognition memory of 11.4%; this persisted for four weeks after the treatment. Brain Stimul. 2012 Jul;5(3):223-30. doi: 10.1016/j.brs.2011.06.006. Epub 2011 Jul 27.
7. Prolonged visual memory enhancement after direct current stimulation in Alzheimer’s disease. Boggio PS1, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M, Tadini L, Scarpini E, Fregni F, Priori A.
8. Improvement on working memory task. Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, et al. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep; 166(1):23–30. [PubMed: 15999258]
9. Improving attention. Stone DB, Tesche CD. Transcranial direct current stimulation modulates shifts in global/local attention. Neuroreport. 2009 Aug 5; 20(12):1115–1119. [PubMed: 19590395]
10. Improving attention. Sparing R, Thimm M, Hesse MD, Kust J, Karbe H, Fink GR. Bidirectional alterations of interhemispheric parietal balance by non-invasive cortical stimulation. Brain. 2009 Jun 15; 132(Pt 11):3011–3020. [PubMed: 19528092]
11. Faster information processing and decision making. Hecht D, Walsh V, Lavidor M. Transcranial direct current stimulation facilitates decision making in a probabilistic guessing task. J Neurosci. 2010 Mar 24; 30(12):4241–4245. [PubMed: 20335459]
12. Faster information processing and decision making. Kincses TZ, Antal A, Nitsche MA, Bartfai O, Paulus W. Facilitation of probabilistic classification learning by transcranial direct current stimulation of the prefrontal cortex in the human. Neuropsychologia. 2004; 42(1):113–117. [PubMed: 14615081]
13. Brain Cogn. 2014 Apr;86:1-9. doi: 10.1016/j.bandc.2014.01.008. Epub 2014 Feb 8. Working memory improvement with non-invasive brain stimulation of the dorsolateral prefrontal cortex: a systematic review and meta-analysis. Brunoni AR1, Vanderhasselt MA2.
14. Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation–technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003; 56:255–276. [PubMed: 14677403]
15. Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27; 57(10):1899–1901. [PubMed: 11723286]
16. Stagg CJ, Best JG, Stephenson MC, O’Shea J, Wylezinska M, Kincses ZT, et al. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22; 29(16):5202–5206. [PubMed: 19386916]
17. Rango M, Cogiamanian F, Marceglia S, Barberis B, Arighi A, Biondetti P, et al. Myoinositol content in the human brain is modified by transcranial direct current stimulation in a matter of minutes: a 1H-MRS study. Magn Reson Med. 2008 Oct; 60(4):782–789. [PubMed: 18816828]
18. Boggio PS, Nunes A, Rigonatti SP, Nitsche MA, Pascual-Leone A, Fregni F. Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Restor Neurol Neurosci. 2007; 25(2):123–129. [PubMed: 17726271]
19. Brain Stimul. 2012 Jul;5(3):223-30. doi: 10.1016/j.brs.2011.06.006. Epub 2011 Jul 27. Prolonged visual memory enhancement after direct current stimulation in Alzheimer’s disease. Boggio PS1, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M, Tadini L, Scarpini E, Fregni F, Priori A.

More references are here: The Science Behind Intellihat