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Use only the vagus nerve stimulation device prescribed or specifically provided for your treatment, and follow its current, country-specific instructions and your clinician’s directions. “Vagus nerve stimulation device” can mean very different things: the prescription gammaCore Sapphire is applied to the side of the neck, while Vivistim is an implanted system used at home as part of clinician-directed stroke rehabilitation. Their placement, programming, purpose and safety rules are not interchangeable.

First identify which device you have

Device What it is for What home use involves
gammaCore Sapphire A prescription, noninvasive device for its labeled headache indications. The user applies it to the side of the neck according to the prescription and the device’s current instructions.
Vivistim Paired VNS System An implanted system for a specific rehabilitation purpose: use with therapy for moderate to severe upper-limb motor deficits after chronic ischemic stroke. A provider programs the implanted system and trains the patient. At home, the patient uses a magnet to start stimulation during prescribed exercises; the patient does not operate the clinician programming software.

These are examples, not a complete inventory of VNS devices. A consumer ear clip, generic stimulator or TENS unit is not automatically equivalent to either system. Do not transfer one product’s placement or schedule to another.

Using gammaCore Sapphire at home

gammaCore is prescription-only in the United States. Its reviewed instructions are revision 2; the manufacturer provides regional safety materials, so check that the current guide matches your country and device before relying on a saved or older copy. The directions below describe gammaCore specifically, not VNS devices generally.

Prepare and place the device

  1. Use the treatment location and schedule prescribed for you. Make sure the skin at the treatment location is clean and dry.
  2. Remove the device cap and put a pea-sized amount of the device’s gel on the stimulation surfaces, as directed in the guide.
  3. Position the device at the illustrated treatment location on the side of the neck. The guide’s landmarks are near the pulse, in front of the large side-neck muscle, just below the jaw and beside the windpipe. Use the full guide’s illustration to locate the site; do not guess at placement.
  4. Apply mild to moderate pressure to maintain skin contact, without pressing excessively on the neck.
  5. Increase intensity to the maximum level you can tolerate, as the guide directs. A stimulation lasts two minutes.

Follow your prescribed schedule, not a general schedule

The gammaCore guide gives different treatment schedules and daily maximums for migraine and cluster headache, and says a provider may direct otherwise. Therapy availability is loaded according to the health care provider’s prescription. Because the schedules differ by indication and prescription, there is no single dosing schedule that is safe to infer from the phrase “vagus nerve stimulation.” Follow your own prescription and applicable current guide; do not add, repeat or compress sessions based on another person’s directions.

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Know what treatment should feel like

The manufacturer describes tingling at the contact area that may spread toward the corner of the mouth, and a slight downward pull of the lip, as possible sensations. It says treatment should never be painful. Stop and contact your prescriber if stimulation is painful rather than trying to overcome pain by increasing intensity. If treatment does not help, the guide says to continue usual medications and seek medical attention if necessary; do not use the device as a substitute for your established care plan.

Check gammaCore contraindications and precautions before use

The manufacturer’s FAQ summary lists the following gammaCore contraindications. It also names groups for whom safety and efficacy have not been evaluated. This condensed list is not a replacement for the full current instructions, and warnings can vary by product version and country.

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  • Contraindications listed by the manufacturer: an active implanted medical or electronic device, such as a pacemaker; or simultaneous use of another stimulation device, such as a TENS unit or muscle stimulator, or a portable electronic device.
  • Safety and efficacy not evaluated, according to the manufacturer: carotid atherosclerosis; a metallic implant at or near the neck; prior cervical vagotomy; children younger than 12; pregnancy; and clinically significant hypertension, hypotension, bradycardia or tachycardia.

If you have one of these conditions, an implanted device, a history of a neck procedure, or any uncertainty about using another electronic or stimulation device at the same time, ask your prescriber before using gammaCore. Do not try to work around a listed contraindication by changing placement or timing.

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Using an implanted Vivistim system at home

Vivistim is not a self-installed or general-wellness home stimulator. FDA’s August 27, 2021 announcement describes it as an implanted system used with rehabilitation therapy for a specific post-stroke indication. Its pulse generator is implanted in the chest, with a lead under the skin to electrodes on the left side of the neck. A health care provider programs the system; patients receive training and a magnet to start stimulation during prescribed exercises. Follow the rehabilitation team’s instructions for session timing and safety features, and contact the team rather than attempting to program or adjust the implant yourself.

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The FDA announcement described a study of 108 participants at 19 clinical sites in the United States and United Kingdom. After six weeks, average Fugl-Meyer upper-extremity assessment improvement was 5 points in the treatment group and 2.4 points in the control group. At 90 days after therapy, 47.2% of the treatment group and 23.6% of the control group had improved by at least 6 points. These are results reported for that study population, not a prediction or guarantee for an individual patient. The FDA announcement also discusses adverse events observed in that study and medical-history topics to review with providers; those findings should not be treated as a complete warning list or applied to noninvasive devices.

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When to check with a clinician

  • Before starting, if you are unsure which device or indication your prescription covers, or whether your instructions match your country and device version.
  • Before using gammaCore if you have an implanted electronic device, a condition or history in the manufacturer’s caution list, or a question about concurrent device use.
  • During gammaCore treatment if the stimulation is painful; do not increase intensity to push through pain.
  • If your prescribed treatment is not helping, follow the gammaCore guide’s advice to continue usual medication and seek medical attention if necessary.
  • For Vivistim programming, training, exercise timing, or device concerns, contact your rehabilitation or implant-care team.

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