Another Lesson in DON”T TRUST THE INTERNET

FACT: Internet articles on hacking TENS units for Vagus Nerve Stimulation reflect a basic lack of training, education, knowledge and research, and are simply FALSE.

TENS units are not equipped to produce the parameters required for VNS nor any other Auricular nerve application.

Irresponsible HACKER articles like this one on INSTRUCTABLES  claim that a clincial grade Vagus Nerve Stimulator can be hacked by using an InTENSity TENS unit and spring-tensioned clips applied to the tragus.

We know the bioelectronic specs of this unit well because we evaluated it as an inexpensive signal generator, but found the following:

1. The “InTENSity Micro” device does not output the correct signal parameters.  This cannot be corrected.  It’s a hardware issue.

2.  The “InTENSity Micro” user-interface (UI) is the worst, most difficult UI ever.

3.  The Ear Clips:  Even without hacking them, they are designed to cause pain compression as nipple-clips.  The springs used in the clips are guaged (i.e., for compression strength) for one large block (containing the conductive silicon block) and one slim counter pad.  Putting two of the large silicon blocks in one clip backloads the spring, effectively multiplying its compression force.  Ouch!

Research has repeatedly shown VNS circuit activations require specific pulse parameters which are not used in TENS nor available on TENS devices.

Additionally, TENS electrodes are the  parallel plane (mono-plane) 2D type described previously, and will cause painful stinging sensation.

Due to skin resistance, plastic-clip compresson electrodes on the tragus channel electric current 2-dimensionally (2D) across the short distance around the tragal contour, superiorly to inferiorly, and vice versa.

I posted this information on the instructables website over a year ago but their Hackeratti hacker geniuses apparently didn’t appreciate the illumination  and removed it.

Who Should NOT Use Vagus Nerve Stimulation

Except under a physician’s direct care, you MUST avoid VNS if you have any other the following:

ANY implanted medical / therapeutic device such as

• a pacemaker,
• insulin pump, or
• an implanted Deep Brain Stimulator (for Parkinson’s)
• an implanted nerve stimulator for pain.

Any of the Following Conditions, Except under a physician’s direct care:

• Pregnancy,
• Asthma,
• Chronic pulmonary disease,
• Heart Disease
• Active peptic ulcer disease,
• Insulin-dependent diabetes mellitus.

Activities to AVOID during Stimulation Sessions

Do not use the Stimulator in or around water, including bath/shower, hottub, sauna, jacuzzi, pool, etc.

Avoid driving (operating a motor vehicle), piloting aircraft and operating heavy equipment.

Avoid bike riding, scooters, skateboards, horse-riding, and all other forms of non-motorized mobility while using stimulation.

If you have any balance or gait problems, avoid walking while using stimulation.

If you are prone to falls, avoid using stimulation while ambulating.

Do not use stimulation during exercise, except under the direct supervision of a responsible Healthcare professional.

Do not perform Stimulation while you are under the influence of an sedative, narcotic, or other drug (or substance) effecting the Central Nervous System.

Electrophoresis and Electrode Startup

After you prep your electrode site (e.g., Concha Cymba) on both front and rear surfaces (for 3D Stimulation), apply a dot of gel on each surface and enter stimulator settings:

Electrophoresis explains how microcurrent electricity transfers from electrodes through the fluids in skin and the layers of tissue below (stratum corneum and epidermis) to reach a target nerve.

The Electrophoresis WAIT-STATE.

During the initial stages of Stimulation, your body is learning how to carry, transfer and direct microcurrent electricity.

When you first turn on your stimulator (with skin prepped and all electrodes attached), it can take up to 60 seconds for the current to find an electrical path through your ear tissue to the target nerve.  So be patient, but also consider the following:

The Speed of Electrophoresis — the process of establishing the electrical pathway between front and rear electrodes — may reflect positioning and alignment of electrodes.  The longer it takes to feel the electrode signal, the more likely it needs to be re-positioned.  30 Seconds is ample time to establish the electrical pathway.

Poor Electrode Position is often due to individual surface variances of the human ear and can be corrected by checking electrode position and by SLOWLY rotating (“rocking”) the earpiece clock-counterclockwise around the saddle-like “crotch” behind the ear.

Poor Electrode Alignment (between Front-Rear electrodes) is usually mitigated by electrode magnetics, but it is still possible for an electrode to loose its position, e.g., during sudden jerky movement activity or when there is a sizing issue with the earpiece (i.e., too small).

Findings from a comprehensive meta-analytic study of VNS:

Out of a total 30 serious adverse events (SAE) only 3 were assessed to be “possibly” caused by tVNS,^[i] with 99.77 percent experiencing no SAEs – a truly impressive, peerless safety statistic.

Methods: A systematic published and grey literature search was carried out to identify studies which deployed tVNS in human subjects. Study authors were contacted for safety/tolerability data if these were not available in the publication. Databases were searched from 1966 to May 2017. We noted study type, population, stimulation parameters, type and prevalence of side effects and/or serious adverse events (SAE). We also noted whether side effects/SAE were considered to be related to the tVNS and the proportion of participants dropping out of studies due to side effects.

Results: 51 studies were included comprising a total of 1322 human subjects receiving tVNS.

The most common side effects were:

• local skin irritation from electrode placement (240 participants, 18.2%),
• headache (47, 3.6%) and
• nasopharyngitis (23, 1.7%).

Whilst heterogeneity in overall side effect event rates between studies was not accounted for by the frequency (Hz) or pulse width (ms) of stimulation, a minority (35 participants (2.6%)) dropped out of studies due to side effects. Overall, 30 SAE occurred but only 3 were assessed by the relevant researchers to be possibly caused by tVNS.

[i]       Redgrave, J. et al. (2018).  Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review.    Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation, Volume 11, Issue 6, 1225 – 1238.  https://pubmed.ncbi.nlm.nih.gov/30217648/

COOLSTIM Battery Life & Recharging

Coolstim is equipped with a lithium rechargeable battery.

Battery Life under normal use: 20 hours.

Use only the Charging Cable supplied with your COOLSTIM.

Failure to Use COOLSTIM charger can void your COOLSTIM Warranty.

Electrodes must be Cleaned
Electrodes must be cleaned (with 70-90 percent Isopropyl alcohol) after each use to remove any accumulation of dead skin, electrode gels, skins oils and any user-applied substances such as moisturizers and the like.

ELECTRODE CONNECTION and CONDUCTANCE

COOLSTIM monitors electrode connections as a function of resistance.

If an electrode is inadequately connected to the auricle, it will not conduct the stimulation signal.

CONNECTION ALARM:  Occurs when (Most to Least likely):

1. there is insufficient site and electrode preparation;
2. the Conductive connection between the electrode and the skin is disrupted.
3. an electrode cable is defective
4. an electrode cable jack is defective

Connection ALARM from the Stimulator:  Causes

1. Human Skin Prep:  Make sure you have properly and adequatelty prepped the electrode sites with Alcohol and removed any accumulations of skin oils, debris, and skincare products.
2. Mechanical:  Check the seating of the cable-jacks to ensure they are fully inserted into their ports.  If needed, replace the cable.  If jack-seating and cable replacement do not turn-off Connection Alarm, then electrode may need to be replaced.

ELECTRODE CONNECTION and CONDUCTANCE

COOLSTIM monitors electrode connections as a function of resistance.

If an electrode is inadequately connected to the auricle, it will not conduct the stimulation signal.

CONNECTION ALARM:  Occurs when (Most to Least likely):

1. there is insufficient site and electrode preparation;
2. the Conductive connection between the electrode and the skin is disrupted.
3. an electrode cable is defective
4. an electrode cable jack is defective

Training in Vagus Nerve Stimulation is available via

1.  Online Video Training;
2.  Through a local Therapist or healthcare practitioner;
3.  A combination of Therapist and Online Video training.

If there is no Therapist in your area, please let us know and we’ll try to locate one for you.

During the early life of a device, errors of use (i.e., user errors) are statistically the most likely cause of device performance problems due to a learning curve.  COOLSTIM has been designed to have a very short learning curve, but the human attention span continues to shrink.  User errors will happen during the early, first-use period.

Electrodes must be Cleaned
Electrodes must be cleaned (70-90 percent Isopropyl alcohol) after each use to remove any accumulation of dead skin, electrode gels, skins oils and any user-applied substances such as moisturizers and the like.

ELECTRODE CONNECTION and CONDUCTANCE

1. COOLSTIM monitors electrode connections as a function of electrical resistance (Ohm’s law).
2. If an electrode is inadequately connected to the auricle, it will not conduct the stimulation signal.

Electrode Lifespan

• under NORMAL  use (1X-2X day):  9 mo. to 1 year
• under FREQUENT  use (2X – 3X day): 6 to 7 months
• under HEAVY use (4X – 5X day): 3 to 5 months

Signs of Electrode Wear

1. Loss of conduction is often the primary sign of an expended electrode.
2. If there is a upward shift in the Current Intensity required to produce perceptible (perception threshold) stimulation.

Discoloration of the metal electrode coating is a normal sign of wear that may indicate the need for replacement.

Damaged Electrodes and Electrode Breakage:

1. If the electrode or its wearable assembly are visibly damaged, DO NOT USE it.
2. Return any damaged electrode to use for examination and replacement.
3. Electrodes still under warranty (90 Days) will be replaced free of charge.

COOLSTIM Electrodes should be Replaced When

Any of the following occur:

1. Breakage of the earpience, electrodes or electrode cable.
2. There is visible damage to the electrode or cable
3. Consistent use of high Intensity Levels to achieve Stimulation perception threshhold.