Marom Bikson of Soterix Medical and CUNY – DIY tDCS Podcast Episode #3

Marom Bikson is CEO of Soterix Medical and Associate Professor at City College of New York in the Department of Biomedical Engineering. Marom is a distinguished tDCS scientist and prominent in the development of HD-tDCS. Download the interview here (zipped mp3). (Firefox users- there is an audio player here, but it’s displaying intermittently. Trying to track down the issue. In the meantime you can download the episode or open the page in another browser).

Marom Bikson

Marom Bikson

(We got a good forty minutes of interview in before the Skype gremlins caught up with us. I had to cobble an ending together.)

Show Notes:
Post-Doc, Neurophysiology Unit, University of Birmingham Medical School, U.K., 2003
Ph.D., Biomedical Engineering, Case Western Reserve University Cleveland, OH, 2000
B.S., Biomedical Engineering (EE Concentration), Johns Hopkins University, Baltimore, MD, 1995
Introduction to Transcranial Direct Current Stimulation (tDCS) in Neuropsychiatric Research
5th International Conference on Non-invasive Brain Stimulation 2013

Instrumentation – making medical gizmos, process.
IRB- Institutional Review Board
IRB at the FDA
Small Business Technology Transfer STTR grant.

Soterix partners
Abhishek Datta CTO,
Lucas Parra
Bootstrapped at this point.

Difficulty in engineering medical devices is in designing for the anomalous cases- how that 1 in 999 times situation could go wrong.

Clinical trials. Depression, (Colleen Loo, Blackdog Institute), pain, stroke, epilepsy clinical trials ongoing.

Customizing technologies to match needs of particular clinical situations.

Soterix developed software designed for clinicians.
HDTargeting
HDExplore
Modeling current flow through the head.

Perhaps depression studies are closest to FDA qualification for tDCS?
(Prediction is very hard, especially about the future – Yogi Berra.)

A device (NorDoc Smartstim) that can go to 4mA is being used in a smoking cessation trial? (Trial info indicates 2mA current dose.)

FDA tDCS approval would be device-specific at first.  But would open the door to ‘me too’ mechanism, FDA 510(k)

HD tDCS can have multiple cathodes and or multiple anodes. An array of 4 small anodes splitting 2mA, for example (.5 mA each electrode), can function as an anodal ‘virtual pad’. Assumes cathode somewhere else on the body).

Image By Richard McKinley USAF

Image By Richard McKinley USAF

Tolerability is how tolerable in terms of side effects a medication is.

Transcutaneous Spinal Direct Current Stimulation Example tsDCS paper.

A Theory of tDCS (“Gross oversimplification”) As positive current flows into the cortex it passes neurons.
Because of the nature of neurons, this positive current depolarizes somas (cell’s body), increasing excitability, thereby increasing the functionality & plasticity of that region (hypothesis… “We really don’t know.”). Under the cathode, somas (cells) are being hyper-polarized – excitabilty decreases.

A synapse is a structure that permits a neuron (or nerve cell) to pass an electrical or chemical signal to another cell.
Pyramidal neuron

Titration, also known as titrimetry, is a common laboratory method of quantitative chemical analysis that is used to determine the unknown concentration of an identified analyte.

TES Transcranial Electric Stimulation
“transcranial electrical stimulation” Merton and Morton 1980

“Priming the network in conjunction with applying tDCS makes a lot of sense, as a way to make the tDCS to do what you want.” (Co-priming – The idea that one would initiate an activity first, and THEN add tDCS.)

DARPA supported accelerated learning.

Memory consolidation.
Lisa Marshall

H. Branch Coslett, MD

DIY tDCS community and building medical devices. Redundancy.
tDCS implies proven, vetted protocols, that have been used in clinical trials.

Thanks Marom!

Recent tDCS Papers of Interest

  1. Acute working memory improvement after tDCS in antidepressant-free patients with Major Depressive Disorder. All effect sizes were large. In other words, one session of tDCS acutely enhanced WM in depressed subjects…(Paywall)
  2. Neurobiological Effects of Transcranial Direct Current Stimulation: A Review The purpose of this systematic review is to summarize the current knowledge regarding the neurobiological mechanisms involved in the effects of tDCS. (pdf)
  3. Modulating Human Procedural Learning by Cerebellar Transcranial Direct Current Stimulation. Our finding that anodal cerebellar tDCS improves an implicit learning type essential to the development of several motor skills or cognitive activity suggests that the cerebellum has a critical role in procedural learning. (Paywall)
  4. Neuroenhancement of the aging brain: Restoring skill acquisition in old subjectsThese results suggest noninvasive brain stimulation as a promising and safe tool to potentially assist functional independence of aged individuals in daily life. (Paywall)
  5. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Although this study is limited by the small sample size, the results show promise for treating refractory auditory verbal hallucinations and other selected manifestations of schizophrenia. (Paywall)
  6. Modulation of training by single-session transcranial direct current stimulation to the intact motor cortex enhances motor skill acquisition of the paretic hand.These results indicate that tDCS is a promising tool to improve not only motor behavior, but also procedural learning. (Paywall)
  7. Interactions between transcranial direct current stimulation (tDCS) and pharmacological interventions in the Major Depressive Episode: Findings from a naturalistic study. tDCS over the DLPFC acutely improved depressive symptoms. Besides the inherent limitations of our naturalistic design, our results suggest that tDCS effects might vary according to prior pharmacological treatment… (Paywall)
  8. Amelioration of Cognitive Control in Depression by Transcranial Direct Current StimulationDeficient cognitive control over emotional distraction is a central characteristic of major depressive disorder (MDD). The present study demonstrates that anodal tDCS applied to the left dlPFC improves deficient cognitive control in MDD. (Paywall)
  9. Comparing immediate transient tinnitus suppression using tACS and tDCS: a placebo-controlled study. Our main result was that bifrontal tDCS modulates tinnitus annoyance and tinnitus loudness… (Paywall)
  10. Review of transcranial direct current stimulation in poststroke recovery. In this review, we summarize characteristics of tDCS (method of stimulation, safety profile, and mechanism) and its application in the treatment of various stroke-related deficits… (Paywall)
  11. Enhancing vigilance in operators with prefrontal cortex transcranial direct current stimulation (tDCS)These findings indicate that tDCS may be well-suited to mitigate performance degradation in work settings requiring sustained attention or as a possible treatment for neurological or psychiatric disorders involving sustained attention. (Paywall)

 

Dr. Jim Fugedy of the Brain Stimulation Clinic in Atlanta – DIY tDCS Podcast #2

[Apologies for audio quality. It won’t happen again.]

Dr. Jim Fugedy runs the Brain Stimulation Clinic, in Atlanta, GA, and has been treating patients using tDCS since 2007. Download the interview here (zipped mp3).

Dr. Jim Fugedy

Dr. Jim Fugedy

The Brain Stimulation Clinic in Atlanta is the destination for memory and learning enhancement and treatment-resistant patients who suffer from chronic pain, fibromyalgia, migraine headaches, CRPS, depression and tinnitus. Transcranial direct current stimulation (tDCS) therapy is provided in a pleasant, relaxing environment. Instruction, training and supervision for home use is also available for select patients.

Show Notes:
Jim is an anesthesiologist.
The study Jim refers to regarding Felipe Fregni & fibromyalgia:
A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia (full pdf)
tDCS for treatment of fibromyalgia is not certified – it’s ‘off label’
Device is certified, but not for tDCS = no insurance code, can’t be billed to insurance
20 minute treatment for 5 days.
For fibromyalgia – reduces pain, improves issues – fatigue, compromised mental function
2″ electrodes
(ActivaDose ii Update 3/16 now available as complete tDCS kit through Caputron Medical, use voucher code ‘diytdcs’ for generous discount.)
Most benefit… chronic depression, treatment protocol based on Colleen Loo, Black Dog Institute 6 weeks, follow up maintenance. Up to 8 weeks of treatment + 1-2 treatments follow up maintenance.  Daily 20 minute sessions
Can be treated at the clinic for 1-2 weeks. Or home treatment package.
“To treat depression, I place the anode over the left dlpfc (left dorsolateral prefrontal cortex) and the cathode over the contralateral supraorbital area. I have tried positioning the cathode over the contralateral dlpfc and extracephalically (opposite shoulder or upper arm), but the contralateral supraorbital locations provides the most robust effect.” (Correspondence)
Pain montage 2mA, anode M1 & cathode contralateral supra-orbital area

A-M1-C-contralateral-supraorbital

anode at the right primary motor cortex (M1)–cathode on the left supra-orbital From: http://www.sciencedirect.com/science/article/pii/S1053811907000055

For chronic pain, the M1 is the most used area and that’s almost always my first choice.  But you can use the cathode over the somatosensory (S1) cortex, to down-regulate the patient’s perception of pain.
And you can also stimulate the Dorsalateral prefrontal cortex which is involved in the emotional component of pain.
Looking at stimulating right dorsalateral prefrontal cortex to attenuate anxiety.
… it may be a location
for the non-pharmaceutical treatment for ADD.
Office visit $150.
Home use treatment package $2400 includes in-office evaluation and training, ActivaDose ii device, electrodes, and unlimited follow-up via visit,  phone, skype…
Only side effect Jim has seen is skin burn (but easily avoided with sponge electrodes).
(Patient with skin burns who’d been treated by a doctor using electroencephalogram (EEG) electrodes.)
Tinnitus responds well, though temporarily, to tDCS
Anode, right dorsalateral prefrontal cortex, cortex opposite supra-orbital
Harvard one day course on how to treat with tDCS. Taught 3-4 times a year.
Contrast with approved Electromagnetic treatment for depression (I think he’s referring to TMS transcranial magnetic stimulation here) A 6 week 30 treatment protocol costs between $10-15,000. Affects last about 6 months. And even though it’s certified, it’s not covered by insurance.
…”in the 12 years that it’s been used there have been no side effects reported other than skin (irritations).
“You know we hear stories about Canadians having to wait for surgery. But in the United States, if you don’t have the money and you don’t have insurance,  you don’t have to worry about waiting, you won’t get the surgery.”

You can reach Jim at: doctorfugedy [theAtSignHere] transcranialbrainstimulation.com
Thanks Jim!

Behind Valkee: The Profitable Startup That Shines Lights Into Your Ears To Cure The Winter Blues | TechCrunch

We had a look at the Valkee earlier on the blog. I just bring it up again because it’s interesting that TechCrunch is covering it and pointing out its ‘successful startup’ aspect. I can’t imagine a DIY version of this could cost more than a few dollars.

“I told him you don’t need to your light your house. You need to light your brain,” Nissila said. The ear canal was the most natural and obvious way to shine light onto the surface of the brain. Within weeks, they had a prototype.

Called The Valkee, the device looks like an MP3 player with a set of fancy headphones attached to it. The earbuds actually have a pair of lights attached to them that run for 12-minute sessions at a time. The idea is that by shining light into sensitive areas of the brain, it will stimulate a special OPN3 protein in parts of the brain that help regulate serotonin, melatonin and dopamine production.

They’re initially marketing it to people with Seasonal Affective Disorder, but they’re planning to expand their consumer base to people who need to fight off jet lag.

“If I stop using it for one week, I start eating more and it becomes very difficult to wake up in the morning,” said Timo Ahopelto, who was CEO of the company before leaving to join early-stage Finnish VC fund Lifeline Ventures, which also holds a stake in Valkee. I’ve used it, and I can’t tell if there is any effect yet beyond making my ears feel warm in the morning. But I’m also Californian, so I’m not even really sure I suffer from seasonal affective disorder because we don’t really have seasons.

via Behind Valkee: The Profitable Startup That Shines Lights Into Your Ears To Cure The Winter Blues | TechCrunch.

Transcranial Direct Current Stimulation (tDCS): The Most Effective Treatment for Depression You’ve Never Heard Of

Timothy Sexton has been covering tDCS on the Yahoo Contributor Network.

You name an antidepressant and I have tried it. I have even been on the verge of getting electro-convulsive therapy to treat my depression. And yet not once-not one single time-have I ever heard any of these doctors bring up transcranial direct current stimulation or use the term tDCS.

As a writer and a victim of clinical depression, I have collected a small library of books related to health concerns. Many of these books specifically focus on alternatives to mainstream American approaches to treating illnesses. Not a single one of these books mentions tDCS at all. Not for improving cognition, not for treating pain and not for treating depression. Nada. Nothing. Zilch.

He ends the article with…

I am going to be undergoing tDCS treatment for depression myself and follow-ups to this article will provide a first-person investigation into how this alternative treatment actually affects mood and behavior.

I’ll be keeping an eye out for Timothy’s follow-up.

via Transcranial Direct Current Stimulation (tDCS): The Most Effective Treatment for Depression You’ve Never Heard Of – Yahoo! Voices – voices.yahoo.com.
See Also: Treatment of depression with transcranial direct current stimulation (tDCS): A Review (pdf)

tDCS Clinical Trials Seeking Volunteers

There seems to be a LOT of activity going on in the medical profession around tDCS. You can monitor ClinicalTrials.gov to keep an eye on new and recruiting tdcs studies. If you start here and modify your search with your location, you may find a study in your area.

Devices mentioned in the studies:
Eldith DC stimulator (13 mentions) [Also translated from the German neuroconn.de]
Magstim Company Ltd. UK (1 mention)
Soterix tDCS device (1 mention)

8 Recruiting Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

Condition: Stroke
Interventions: Procedure: tDCS: noninvasive brain stimulation;   Behavioral: Constraint induced movement therapy (CIMT);   Procedure: Sham tDCS: placebo noninvasive brain stimulation
9 Recruiting Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain Due to Burn Injury

Conditions: Pain;   Burn Injury
Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
10 Recruiting Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction

Conditions: Behavior, Addictive;   Smoking
Interventions: Procedure: sham tDCS;   Procedure: active tDCS

Transcranial direct current stimulation in the treatment of depression | Medicographia

This is the single example of the frequently sited Eldith device matched to a photo of the device. I’m not sure if perhaps neuroConn changed the name of the device, or…?

 

Transcranial direct current stimulation (tDCS)

_ Mechanism of action
Contemporary tDCS protocols typically involve the application of a 1 mA or 2 mA direct current (DC) for up to 20 minutes between two surface electrodes. These may vary in size, but are commonly _35cm2 (5×7 cm). The electrodes are placed on the scalp, one serving as the anode and the other as the cathode. Current flows from the anode to the cathode, some being diverted through the scalp and some moving through the brain.15

Figure 2
Figure 2. Eldith transcranial direct current stimulation (tDCS)
stimulator with electrodes. Photo by the author.

Figure 3

via Transcranial direct current stimulation in the treatment of depression | Medicographia.

Frontiers | Effects of frontal transcranial direct current stimulation on emotional processing and mood in healthy humans | Frontiers in Neuropsychiatric Imaging and Stimulation

We aimed to evaluate the effects of prefrontal tDCS on mood and mood-related cognitive processing in healthy humans. In a first study, we administered excitability-enhancing anodal, excitability-diminishing cathodal and placebo tDCS to the left dorsolateral prefrontal cortex, combined with antagonistic stimulation of the right frontopolar cortex, and tested acute mood changes by an adjective checklist. Subjective mood was not influenced by tDCS. Emotional face identification, however, which was explored in a second experiment, was subtly improved by a tDCS-driven excitability modulation of the prefrontal cortex, markedly by anodal tDCS of the left dorsolateral prefrontal cortex for positive emotional content. We conclude that tDCS of the prefrontal cortex improves mood processing in healthy subjects, but does not influence subjective mood state.

via Frontiers | Effects of frontal transcranial direct current stimulation on emotional processing and mood in healthy humans | Frontiers in Neuropsychiatric Imaging and Stimulation.

Frontiers | USING TRANSCRANIAL DIRECT CURRENT STIMULATION TDCS TO TREAT DEPRESSION IN HIV-INFECTED PERSONS: THE OUTCOMES OF A FEASIBILITY STUDY | Frontiers in Neuropsychiatric Imaging and Stimulation

Depression scores significantly decreased p<.0005 after the treatment. No serious adverse events occurred. Several transient minor AEs and occasional changes of blood pressure and heart rate were noted. Mini-mental status scores remained unchanged or increased after the treatment. All subjects were highly satisfied with the protocol and treatment results and described the desire to find new treatments for HIV-MDD as motivating participation. Conclusions: F indings support feasibility and clinical potential of tDCS for HIV-MDD patients, and justify larger-sample, sham-controlled trials.

via Frontiers | USING TRANSCRANIAL DIRECT CURRENT STIMULATION TDCS TO TREAT DEPRESSION IN HIV-INFECTED PERSONS: THE OUTCOMES OF A FEASIBILITY STUDY | Frontiers in Neuropsychiatric Imaging and Stimulation.