Indications for Use and Patient Safety of Pulsed Magnetic Stimulation Device

Intended Use: The Pulsed Magnetic Stimulation Device is intended for non-invasive stimulation of the human central and/or peripheral nervous system.

Indications:

Adjuvant therapy for Major Depressive Disorder (MDD), Neuropathic pain, Obsessive-compulsive disorder (OCD), Parkinson's disease, Motor disorder at the Post-acute stage of stroke.

Warnings:

All operators must consider the following clinical warnings before proceeding with patient treatment using the Pulsed Magnetic Stimulation Device when the patient has the following:

1. Risk of Seizure;
2. Worsening Depression or Suicidality;
3. Risk of Ineffective Therapy;
4. Lack of Evidence for Efficacy or Safety in Specific Patient Populations:
• age less than 13,
• suicide plan or recent suicide attempt,
• varying degrees of medication resistance in either the current or previous episode,
• on concurrent antidepressant medication, i.e., cannot tolerate discontinuation of current antidepressant medication,
• history or concurrent use of electroconvulsive therapy or vagus nerve stimulation,
• depression secondary to a general medical condition or substance-induced,
• seasonal affective disorder,
• history of substance abuse, or post-traumatic stress disorder,
• a psychotic disorder, including schizoaffective disorder, bipolar disease, or major depression with psychotic features,
• neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm or dementia,
• history of increased intracranial pressure or head trauma,
• cardiac pacemakers, implantable cardioverter defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulators, implanted medication pumps, intracardiac lines, or significant cardiac disease, or
• pregnant or breastfeeding women.
5.Wearable/ Removable Medical Devices, Conductive Objects and Other Devices.

Contraindications:

1. Implanted Electronic Devices and/or Conductive Objects near the coil

Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter-defibrillators [ICD’s], vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD’s], ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed. Contraindicated use could result in serious injury or death.

2. Non-Removable Metallic Objects near the coil

Patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (examples: cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments). Failure to follow this restriction could result in serious injury or death.

NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients.

Adverse Effects

The knowledge of side effects allows informing patients about what can happen and how to deal with these effects. The risk of accidental seizure is the most troubling unintended effect of this technique. It is important to know what has happened, the limits to reduce the risk of the treatment, and how best to handle a seizure if it happens.

The main side effects can be divided according to stimulation of CNS and PNS:

CNS stimulation

• Seizures
• Headache
• scalp discomfort
• Nausea
• Vertigo
• Insomnia
• Worsening of depression
• Gastrointestinal
• Fatigue
• Dizziness
• Impaired concentration
• Mania
• Suicidal ideation
• Transient auditory threshold shift
• Tinnitus

PNS stimulation

• Local pain
• Local discomfort
• Skin erythema

Limitations

• Risk of Inducing Voltages and Currents: TMS can induce voltages and currents that may cause malfunction or even damage the internal circuitry of electronic implants like deep brain stimulators and cochlear implants.
• Potential Damage to Cochlear Implants: There are specific concerns about the use of TMS in subjects with cochlear implants due to the lack of safety data and the potential to induce high voltages that can damage the implants​​.
• Effects on Implanted Electrodes: The induced currents during TMS sessions might interact unpredictably with other implanted medical devices, leading to unintended consequences like the activation of motor responses due to induced currents in electrode leads.
• Concerns Over Heating Effects: Repetitive TMS can generate heat which might pose risks, especially when using specific coil types that may overheat.
• To prevent triggering a seizure or other negative side effects, the operator must adhere to the appropriate restrictions on intensity, frequency, duration, ITI, and the number of transcranial stimulations.

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