Frequently Asked Questions

SmartFocus® TMS depression therapy is a non-invasive, device-based treatment, personalized just for you and your brain. As a non-drug treatment for depression, TMS only influences the brain and doesn’t alter the rest of the body’s chemistry.

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SmartFocus® TMS depression therapy is a non-invasive device-based treatment, personalized just for you and your brain. As a non-drug option, TMS only influences the brain and doesn’t alter the rest of the body’s chemistry.

Transcranial Magnetic Stimulation (TMS) refers to the technique of stimulating the brain from outside the head using small electric fields. To be effective in depression therapy, this stimulation needs to reach the part of your brain closely involved in emotion and mood. Doctors know this part by the name the left dorsolateral prefrontal cortex (DLPFC). Studies have shown that in most patients with depression, metabolic activity is reduced in this part of the brain.

TMS used without image-based navigation simply estimates a spot for the stimulation. At Nexstim, we know it is important that TMS targets the right location in your brain – otherwise you may not get the benefit you truly need. So, we use a highly-developed 3D brain imaging model and proven navigation tools to optimize the location: without these tools the changes can’t be even seen. With our tools we can also personalize the stimulation for you.

We think focusing on you as an individual is smart. That is why we are calling our solution SmartFocus® TMS.

No. In electro-convulsive therapy, electric current is conducted from outside the head to inside the brain. ECT is considered as an invasive method requiring that the patient is anesthetized.

In TMS, no electric current is conducted through the scalp: Instead, the magnetic field around the TMS coil passes through the scalp and skull and generates an electric field into the brain tissue. This electric field induced in the brain is able to activate the neurons. TMS is a non-invasive therapy that doesn’t require anaesthesia. In fact, after the TMS therapy session the patient is free to continue his or her daily routine.

ECT can also have side effects, such as memory loss, which are not associated with TMS.

Every individual’s brain is different and the effects of TMS stimulation are always dependent on the state of your own brain That  This is why the state of your brain will be accurately determined so that you can be given a personalized SmartFocus® TMS therapy.

First an MRI scan of your head is taken. Your MRI scan combined with the measurements made by our SmartFocus® TMS gives a detailed image of your brain. With that, it is easy to find the exact spot where the therapy should be targeted in your brain. You can even see the target yourself on the 3D model. In addition, with SmartFocus® TMS, your motor threshold is measured, allowing your clinician to determine the optimal stimulation dose for you.

During therapy, an operator gently stimulates the pre-defined spot of the cortex in your brain using a wand-like TMS coil, resting against your head. When the TMS coil is running, a brief magnetic field passes harmlessly through the head, activating neurons in the cortex under the coil. This procedure doesn’t cause pain, but you may feel a little tingling in the scalp.

The therapy sessions can be repeated easily and accurately, because your vital data are saved. This is how you always receive the same, prescribed dose at the same location.

If you have found antidepressants are not working for you, SmartFocus® TMS therapy by Nexstim may be the answer. TMS has been proven safe and can be very effective with none of the drug-related side-effects.  Ask your doctor about the opportunity to get a SmartFocus® TMS treatment.

Typical treatment course is 5 sessions per week for 6 weeks, or as your doctor prescribes.

After the onetime setup process, where your brain and cortex are accurately measured, each treatment session  ranges between 3-37 minutes, depending on your treatment program. Treatment programs vary by clinic and are personalized to each individual’s needs. Fastest protocol, called intermittent theta burst stimulation (iTBS), takes only about three minutes per session. Your physician will work with you to develop a treatment program tailored to your needs.

After a treatment session, you will be free to resume your daily routine.

Treatment with SmartFocus® TMS will typically take place in a clinic or an office. Afterwards, you will be free to continue your daily routine.

SmartFocus® TMS therapy is also given in inpatient care where the therapy sessions are part of the patient’s treatment routine.

SmartFocus® TMS therapy is given by a trained healthcare professional, who may be a doctor, nurse, or a professionally trained TMS specialist.

Your physician will have assessed your medical condition and medication, to ensure there is no limitation on TMS therapy.

Before starting the SmartFocus® TMS treatment, you will have had an MRI scan of your head taken, either at you own clinic or at the hospital’s radiology department. When you arrive for the first session, you will sit in a reclining seat with a comfortable headrest. Your MRI head scan is uploaded to the TMS System via the hospital computer network (or from a storage medium).

Before the therapy can be started, the treatment will be personalized for you and for your brain. This entails measuring your brain cortex and the stimulating dose that is optimal for you.

To measure the right stimulation dose for you, the operator will place small electrodes on the skin over your hand muscles. The electrodes are normal surface electrodes which use gel or paste. This method of detecting muscle movement is called electromyography (EMG).

In addition, you will be asked to wear a tracker on your forehead with reflecting spheres. The reflective spheres allow an infrared tracking system to follow the movement of your head and the coil in real-time.

The operator will then place a pointer against certain positions on your scalp and enter their locations into the system. This process will align your head with the 3D rendering of your head.

The operator will pick up the wand-like coil and rest it gently against your head. You will not feel any weight on your head.  When the operator triggers the coil, it will induce a stimulating electric field in the underlying cortex of your brain. You will hear a click and you may feel a little tingling on your scalp. Depending on the stimulus strength, you may notice a small twitch in a muscle where the electrodes have been placed.

By moving the coil and stimulating your brain several times, the operator will first find the area in your cortex which causes movement in your (left) thumb muscle. Once the optimal location has been found, the operator will determine how strong the stimulus needs to be to activate your thumb muscle. This level of intensity is your motor threshold. From this result, the operator can set the optimal stimulation power needed to comfortably and reliably conduct the depression therapy.

After that the operator will determine the exact location of the left DLPFC target based on your brain anatomy. The exact spot will be saved, and because of this, you will always receive the therapy on that exact spot.

After these measurements are made in the first session, the therapy can be conducted. In the therapy session, the operator opens your data from the software. He or she will place the headtracker on your forehead, Then the operator can start the therapy by stimulating the previously measured spot with the intensity personalized for you.

You will be asked to sit in a reclining chair with a comfortable headrest.  Any kind of loose hairstyle or comfortable clothing is appropriate. Spectacles and metal earrings need to be removed.

You will be asked to wear a reflector-coated tracker on your forehead. The tracker allows you to move – any change in your head position will be taken into account by the system’s computer. In the first session the operator will also place the electrodes on your hand.

During the therapy session the operator will offer you earplugs to filter out some of the noise caused by the clicking sound coming from the coil It’s important that you are having a relaxed and comfortable position during the therapy session.

Once the session is over the operator will remove the head tracker, the earplugs and any electrodes. You can then continue your daily routine.

The clinical efficacy and safety of 10 Hz rTMS stimulation of the left dorsolateral prefrontal cortex in the treatment of MDD has been studied in a sham-controlled multicenter clinical trial (see O’Reardon et al.*) with an overall population of 301 patients meeting DSM-IV criteria in the diagnosis of MDD. MDD episode as defined by DSM-IV involves the nearly daily presence during the same two-week period of five or more of the following symptoms:

  • Depressed mood most of the day as indicated by either subjective report or observation made by others
  • Markedly diminished interest or pleasure in all, or almost all, activities most of the day
  • Significant weight loss or weight gain, or decrease or increase in appetite
  • Insomnia or hypersomnia
  • Psychomotor agitation or retardation
  • Fatigue or loss of energy
  • Feelings of worthlessness or excessive or inappropriate guilt
  • Diminished ability to think or concentrate, or indecisiveness
  • Recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.

Efficacy of the treatment was established in retrospective analysis (see Lisanby et al.**) for the outpatient group (164 patients, aged 18-70 years) who had one adequate antidepressant treatment in the current episode but failed to achieve satisfactory improvement and were moderately to severely symptomatic. Efficacy of treatment, sham or active stimulation, was measured in total change in MADRS score at 2, 4 and 6 weeks into treatment when compared to baseline level (see the figure).

In a multi-site trial of 414 patients, the efficacy and safety for the 3- minute theta burst protocol has been found to be the same as for the 37-minute 10 Hz protocol. ***

*O’Reardon et al., Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007 Dec 1; 62(11): 1208-1216. Epub 2007 Jun 14. PubMed PMID: 17573044.

**Lisanby et al., Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009 Jan; 34(2):522-34. Epub 2008 Aug 13. PubMed PMID: 18704101.

***Blumberger D. et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial

INDICATIONS FOR USE

FDA: Nexstim Navigated Brain Therapy (NBT) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Nexstim NBT System 2 is intended to be used by trained clinical professionals.

CE mark : Nexstim Navigated Brain Therapy System for depression is intended to be used for treatment of major depressive disorder (MDD)
by targeting and delivering noninvasive repetitive TMS stimulation to the patient’s dorsolateral prefrontal cortex.

NBT THERAPY SHOULD NOT BE GIVEN TO

  1. Patients with non-removable conductive, ferromagnetic, or other magnetic-sensitive metal anywhere in the head or within 30 cm (12 in) of the stimulation coil. Examples include cochlear implants, implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, ocular implants, and stents.
  2. Patients who have an active or inactive implanted device (including device leads), including deep brain stimulators, cochlear implants, cardiac pacemakers, and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
  3. Patients with increased intracranial pressure or patients with intracardiac lines, intravenous pumps, or dose calculators.

Failure to follow these restrictions could result in serious injury or death.

RISKS AND SIDE EFFECTS

Seizures (convulsions): Cortical magnetic stimulation runs the risk of inducing seizures; although they are rare. Under ordinary clinical use, the estimated risk of seizure is approximately 1 in 30 000 treatments (0.003%) or 1 in 1000 patients (0.1%).

Headache: The most common side effects reported during clinical trials are mild headache (~50% of TMS treatment group) and scalp pain or discomfort (35.8%). In general, headache and pain on the stimulation site have been generally mild to moderate and occurring less frequently after the first week of treatment. The reason for headache may be the tension of scalp and neck muscles due to an uncomfortable and stressful situation.

Muscle Twitching:  You may feel twitches in the muscles of your arm, leg or face during the magnetic stimulation. This is a common sensation but not hazardous. The twitches will stop when the magnetic stimulation stops.

Skin Irritation:  There is a small risk of mild skin irritation at the location where the muscle electrode sensors have been placed, but this usually consists of minor redness that will go away quickly after they are removed.

Changes in hearing:  The loud “click” produced by the TMS stimulator can cause temporary hearing changes following treatment.  This is prevented by wearing soft foam ear plugs during treatment. No problems with hearing due to TMS have ever occurred when earplugs have been properly worn

INEFFECTIVE TREATMENT

There is no evidence that single therapy sessions would improve mood.  rTMS treatment effects in reducing depression are temporary, and patients may need to continue other forms of depression therapy. Relapse into depression is likely without follow-up treatment. Notify your doctor in case of worsening depression or suicidality.

CAUTION: SPECIAL POPULATIONS

All patients must be screened for the characteristics listed in this section and excluded without clear benefit or compelling clinical reason.

The safety and effectiveness of Nexstim TMS treatment has not been established in the following patient populations:

  • Younger than 22 years or older than 70 years
  • Suicide plan or recent suicide attempt
  • History of concurrent use of electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS)
  • Depression secondary to a general medical condition or substance-induced
  • Seasonal affective disorder
  • History of substance abuse, obsessive compulsive disorder, or post-traumatic stress disorder
  • A psychotic disorder, including schizoaffective disorder, bipolar disorder, or major depression with psychotic features
  • 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
  • Pregnant or nursing.

The clinical efficacy and safety of 10 Hz rTMS stimulation of the left dorsolateral prefrontal cortex in the treatment of MDD has been studied in a sham-controlled multicenter clinical trial (see O’Reardon et al.*) with an overall population of 301 patients meeting DSM-IV criteria in the diagnosis of MDD. MDD episode as defined by DSM-IV involves the nearly daily presence during the same two-week period of five or more of the following symptoms:
  • Depressed mood most of the day as indicated by either subjective report or observation made by others
  • Markedly diminished interest or pleasure in all, or almost all, activities most of the day
  • Significant weight loss or weight gain, or decrease or increase in appetite
  • Insomnia or hypersomnia
  • Psychomotor agitation or retardation
  • Fatigue or loss of energy
  • Feelings of worthlessness or excessive or inappropriate guilt
  • Diminished ability to think or concentrate, or indecisiveness
  • Recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.

Figure: Change from baseline in MADRS score during active or sham rTMS treatment in patient population with one adequate antidepressant treatment (modified from Reference 10.)

Efficacy of the treatment was established in retrospective analysis (see Lisanby et al.**) for the outpatient group (164 patients, aged 18-70 years) who had one adequate antidepressant treatment in the current episode but failed to achieve satisfactory improvement and were moderately to severely symptomatic. Efficacy of treatment, sham or active stimulation, was measured in total change in MADRS score at 2, 4 and 6 weeks into treatment when compared to baseline level (see the figure).

*O’Reardon et al., Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007 Dec 1; 62(11): 1208-1216. Epub 2007 Jun 14. PubMed PMID: 17573044.

**Lisanby et al., Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009 Jan; 34(2):522-34. Epub 2008 Aug 13. PubMed PMID: 18704101.

Are you a physician interested in offering your patients SmartFocus® TMS treatments?
Visit our physician information page for more information and contact us at info@nexstim.com.