This work was in part supported by the Collaborative Research Center 1158 (SFB1158 From nociception to chronic pain: Structure-Function properties of neural pathways and their reorganization), funded by the DFG (Deutsche Forschungsgemeinschaft).

NOTE: All procedures are performed as individual healing attempts (&#34;Individueller Heilversuch&#34;). And comply with the local ethics board (Ethikkommission Heidelberg) as well as national laws regarding individual healing attempts. Patients are extensively informed by the treating physician about the nature of the therapy, the procedures, the risks and benefits. All patients give written informed consent before beginning with the procedure. Individual healing attempts need the approval for reimbursement by the patie...

<ol>
	<li>Sandel, T., Eide, P. K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Long-term+results+of+microvascular+decompression+for+trigeminal+neuralgia+and+hemifacial+spasm+according+to+preoperative+symptomatology.">Long-term results of microvascular decompression for trigeminal neuralgia and hemifacial spasm according to preoperative symptomatology.</a> Acta Neurochir. (Wien). 155 (9), 1681-1692 (2013).</li><li>Montanto, N., Papacci, F., Cioni, B., Di Bonaventura, R., Meglio, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=What+is+the+best+treatment+of+drug-resistant+trigeminal+neuralgia+in+patients+affected+by+multiple+sclerosis?+A+literature+analysis+of+surgical+procedures.">What is the best treatment of drug-resistant trigeminal neuralgia in patients affected by multiple sclerosis? A literature analysis of surgical procedures.</a> Clin Neurol Neurosurg. 115 (5), 567-572 (2013).</li><li>R&#233;gis, J., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Radiosurgery+for+trigeminal+neuralgia+and+epilepsy.">Radiosurgery for trigeminal neuralgia and epilepsy.</a> Neurosurg Clin N Am. 10 (2), 359-377 (1999).</li><li>Liem, L., Mekhail, N. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Management+of+Post-Herniorraphy+Chronic+Neuropathic+Groin+Pain:+A+Role+For+Dorsal+Root+Ganglion+Stimulation.">Management of Post-Herniorraphy Chronic Neuropathic Groin Pain: A Role For Dorsal Root Ganglion Stimulation.</a> Pain Pract. 16 (7), 915-923 (2016).</li><li>Stadler, J. A., Ellens, D. J., Rosenow, J. 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B., Silberstein, S. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Occipital+Nerve+stimulation+for+primary+headaches.">Occipital Nerve stimulation for primary headaches.</a> J Neurosurg Sci. 56 (4), 307-312 (2012).</li><li>Jakobs, M., Unterberg, A., Treede, R. D., Schuh-Hofer, S., Ahmadi, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Subcutaneous+trigeminal+nerve+field+stimulation+for+refractory+trigeminal+pain:+a+cohort+analysis.">Subcutaneous trigeminal nerve field stimulation for refractory trigeminal pain: a cohort analysis.</a> Acta Neurochir. (Wien). 158 (9), 1767-1774 (2016).</li><li>Klein, J., Sandi-Kahun, S., Schackert, G., Juratli, T. 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With subcutaneous trigeminal nerve field stimulation (sTNFS), we present a surgical technique to perform minimally invasive neuromodulation for chronic refractory pain of the trigeminal nerve of different etiologies.
To reduce complications thorough disinfection of the entire surgical field is vital. Any unnecessary skin perforation can increase the risk of device infection with the consecutive loss of the system. Physicians should always pay attention to the implantation depth of the electrod...

The neurosurgical armamentarium to treat trigeminal pain is as large and diverse as the underlying etiologies. In cases of classical trigeminal neuralgia (TN) caused by arterial compression at the brainstem root entry zone of the trigeminal nerve microvascular decompression (MVD)1 is highly effective. Percutaneous destructive techniques at the Gasserian Ganglion (such as radiofrequency thermocoagulation, glycerol injection or balloon compression2) and stereotactic radiosurgery for trigeminal neuralgia3 can be applied in cases without neurovascular conflict or whenever there are contraindications for open microsurgery. However, all techniques are associated with certain recurrence rates of pain. Furthermore, the treatment itself bears risks for nerve damage resulting in neuropathic pain or even painful post-traumatic trigeminal neuropathy. AT last, trigeminal pain of central origins (e.g. post stroke pain) will not respond to MVD or destructive techniques at the Gasserian Ganglion but needs to be treated by neuromodulation such as deep brain stimulation (DBS) or motor cortex stimulation (MCS).
Neuromodulation is a term used for surgical techniques that appear to alter neural activity without causing irreversible tissue damage. Neuromodulative treatments are reversible, adaptable and usually work with intermittent or continuous application of electrical currents to parts of the peripheral or central nervous system. There are several certified (CE and/or FDA approved) treatments available to treat chronic and/or neuropathic pain of the trunk and the extremities such as epidural spinal cord stimulation (SCS), peripheral nerve field stimulation (PNFS) or dorsal root ganglion stimulation (DRG)4. However, currently there is no CE or FDA approved treatment available for chronic neuropathic facial and trigeminal pain.
Deep brain stimulation (DBS) and motor cortex stimulation (MCS) have been applied in multiple case series for patients with chronic facial pain of different origins5. However, both techniques present a high level of complexity and demand special physician expertise. There is a need for simple, cost efficient and effective neuromodulation for chronic trigeminal and facial pain when conservative treatment fails and destructive techniques want to be avoided.
Besides surgical approaches an array of non-invasive or temporary forms of neuromodulation is available to treat chronic pain (e.g. PENS: percutaneous electrical neurostimulation, TENS: transcutaneous electrical neurostimulation, TMS: transcranial magnetic stimulation).
Subcutaneous peripheral nerve field stimulation (sPNFS) is the least invasive form of neuromodulation6. One or more electrodes are placed in the subcutaneous tissue in the painful area. Continuous electrical stimulation is applied to create a pleasant paresthesia that covers the painful area. The exact mechanism of action is not known. However, despite all shortcomings the similar mechanisms like in the gate control theory &#8211; or variations of it &#8211; which postulates modulation of nociceptive input by inhibitory fibers is most often applied. Furthermore a local depolarization block of the peripheral nerve fibers with reduced excitability and changes in the micro environment regarding inflammatory proteins are discussed7.
As in most neuromodulation procedures a test trial with externalized electrodes connected to a pulse generator is performed to evaluate the effectiveness before a fully implantable pulse generator (IPG) is placed in the subcutaneous tissue and connected to the electrodes as the power source for the stimulation in case of therapeutic success. There is no general definition of a positive test trial however a reduction in pain of 50% or more on the visual analog scale (VAS) is most often regarded as a hallmark criterion. Furthermore, reduction in oral pain medication or increase in quality of life can be factors to favor implantation of a permanent system.
Peripheral nerve field stimulation is certified for the use in chronic low back pain8 and has been used for localized chronic pain syndromes (e.g. post-herniorrhaphy pain). It is also used as occipital nerve stimulation (ONS) to treat chronic migraine and cluster headaches9. Several non-randomized studies have shown the use of sPNFS in the trigeminal dermatomes for chronic and neuropathic intractable pain of different origins (classical TN, atypical TN, post-herpetic trigeminal neuropathy, MS associated trigeminal neuropathy, persistent idiopathic facial pain)10,11,12.
Subcutaneous trigeminal nerve field stimulation (sTNFS) is easy and fast to perform. Contrary to DBS or MCS, sTNFS can be performed as an outpatient procedure (if reimbursed). There is no risk of intracranial or epidural bleeding. Seizures do not occur. Trial stimulation is performed in an ambulatory setting so that the patient can assess the stimulation effect while performing his everyday routine rather than being bound to a hospital bed. No extensive intra- or preoperative imaging is necessary to determine the correct position of the electrodes. sTNFS can be considered as a therapeutic option to modulate pain perception and processing before applying a percutaneous destructive procedure or as a less invasive type of neuromodulation before thinking about MCS or DBS in patients with neuropathic or central pain.

<table border="0" cellpadding="0" cellspacing="0" width="1257">
	<tbody>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">myStim Patient Programmer</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97740</td>
			<td style="width:709px;">enables the patient to turn off and on stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Prime Advanced</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97702</td>
			<td>non-rechargeable IPG as powersource for stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Restore Ultra</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97712</td>
			<td>rechargeable IPG as powersource for stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Charging System</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97754</td>
			<td>used by the patient to recharge the Restore Ultra IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">N&#39;Vision Programmer</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">8840</td>
			<td>used by the physician to program the IPG and define stimulation parameters</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">External Neurostimulator</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">37022</td>
			<td>external IPG as powersource for trial stimulation with externalized electrodes</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Advanced Screening Cable</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">355531</td>
			<td>connects externalized electrodes to the external neurostimulator during trial stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tunnelling Spear 60cm</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3655-60</td>
			<td>used to subcutaneously tunnel the permanent electrodes to an infraclavicular pocket that houses the IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tunnelling Spear 38cm</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3655-38</td>
			<td>used to subcutaneously tunnel the permanent electrodes to an infraclavicular pocket that houses the IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tuhoy Cannula</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3550-32</td>
			<td>14 gauge Epidural Tuhoy cannula (length 9cm) to subcutaneously implant the electrodes</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">InjexFixation Device</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97791 / 97792</td>
			<td>used to fixate the electrodes on the skin or on the muscle fascia</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Octad Compact</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3878-60</td>
			<td>permanent electrode (length 60cm) implanted in the subcutaneous tissue with 8 contacts</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Vectris Trial Lead</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">977D260</td>
			<td>externalized electrode (length 60cm) used during the stimulation trial</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Ethilon*II 3-0</td>
			<td style="width:213px;">Ethicon</td>
			<td style="width:119px;">EH7933H</td>
			<td>non-absorbable suture for skin closure</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Seide 2-0</td>
			<td style="width:213px;">Resorba</td>
			<td style="width:119px;">40221</td>
			<td>non-absorbable silk suture to fixate electrodes and IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Resolon DS21</td>
			<td style="width:213px;">Resorba</td>
			<td style="width:119px;">881413</td>
			<td>absorbable suture for subcutaneous wound closure</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Feather disposable scalpel</td>
			<td style="width:213px;">Feather</td>
			<td style="width:119px;">5205052</td>
			<td>single use scalpel for skin incision and suture cutting</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Scandicain 1%</td>
			<td style="width:213px;">Astra Zeneca</td>
			<td style="width:119px;">23186</td>
			<td>1% Mepivacain solution for local anesthesia</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cosmopor E steril 10x6</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">900871</td>
			<td>Sterile draping for IPG wound</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cosmopor E steril 7,2x5</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">900870</td>
			<td>Sterile draping for skin punctures and small incisions</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Foliodrape Comfort 50x50</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">252302</td>
			<td>Sterile draping for the surgical field</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cephazolin</td>
			<td style="width:213px;">Fresenius</td>
			<td style="width:119px;">6062403.00.00</td>
			<td>Single shot perioperative antibiotic</td>
		</tr>
		<tr height="42">
			<td height="42" style="height:42px;width:216px;">Kepinol forte 800mg/160mg</td>
			<td style="width:213px;">Dr. R. Pfleger Chemische Fabrik</td>
			<td style="width:119px;">2485177</td>
			<td>Postoperative prophylactic oral antibiotic</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Poly-Alcohol</td>
			<td style="width:213px;">Antiseptica</td>
			<td style="width:119px;">UN1219</td>
			<td>Coloured skin disinfectant used during the permanent implantation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cutasept F</td>
			<td style="width:213px;">Bode</td>
			<td style="width:119px;">976800</td>
			<td>Un-Coloured skin disinfectant used during the trial implantation</td>
		</tr>
	</tbody>
</table>

subcutaneous trigeminal nerve field stimulation for refractory facial pain

Chronic or neuropathic trigeminal facial pain can be challenging to treat. Neurosurgical procedures should be applied when conservative treatment fails. Neuromodulation techniques for chronic facial pain include deep brain stimulation and motor cortex stimulation, which are complex to perform. Subcutaneous nerve field stimulation is certified for chronic back pain and is the least invasive form of neuromodulation. We applied this technique to treat chronic and neuropathic trigeminal pain as an individual therapy concept. First, trial stimulation is performed. Subcutaneous leads are placed in the painful trigeminal dermatome under local anesthesia. The leads are connected to an external neurostimulator that applies constant stimulation. Patients undergo a 12 day outpatient trial to assess the effect of the stimulation. Electrodes are removed after the trial. If the patient reports pain reduction of at least 50% in intensity and/or attack frequency, a reduction in medication or increase in quality of life, permanent implantation is scheduled. New electrodes are implanted under general anesthesia and are subcutaneously tunneled to an infraclavicular internal pulse generator. Patients are able to turn stimulation on and off and to increase or decrease the stimulation amplitude as needed.
This technique represents a minimal invasive alternative to other more invasive means of neuromodulation for trigeminal pain such as motor cortex stimulation or deep brain stimulation.

As subcutaneous trigeminal nerve field stimulation (sTNFS) is not a standard treatment and the number of patients that can potentially benefit from it is rather small compared to other diseases, there are only smaller case series that present results of sTNFS. In one series, 10 patients underwent test stimulation for sTNFS. Eight of the patients responded to the therapy and received permanent implantation of electrodes and an IPG11. The patients suffered from trige...

Watch this Scientific Journal Video about Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain at JoVE.com

Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain

Treating chronic or neuropathic facial pain can be challenging when medical or standard treatment fails. Subcutaneous nerve field stimulation is the least invasive form of neuromodulation and is used for chronic back pain. We applied this technology to treat chronic and neuropathic trigeminal facial pain.

Chronic or neuropathic trigeminal facial pain can be challenging to treat. Neurosurgical procedures should be applied when conservative treatment fails. ...

The overall goal of this surgical intervention is to treat patients with chronic therapy-resistant and neuropathic trigeminal pain using minimally invasive subcutaneous nerve field stimulation as a method of neuromodulation. This method can help treat patients with therapy-resistant chronic trigeminal pain such as trigeminal neuralgia or post-therapeutic trigeminal neuropathy who have failed conservative and standard surgical treatment. The main advantage of this technique is that it is minimally invasive, does not destroy any nerve tissue, and its success can be tested in a period of trial stimulation before undergoing permanent implantation.We offer this treatment as an alternative to destructive techniques such as Radiofrequency Thermocoagulation or Gamma Knife Radiosurgery. After a patient has carried out a 12-day stimulation trial, according to the text protocol, turn the anesthetized patient's head to the side contralateral to the pain. Then, place a pillow under the ipsilateral shoulder to expose the clavicle.Shave the area around the ear on the painful side of the face. Then remove any loose hair. If necessary, tape away the surrounding hair to prevent it from moving into the surgical field.Next, thoroughly disinfect the surgical field from the facial area around the ear and down to the clavicle area. From the X-rays of the out-patient appointment, use a sterile surgical pen to mark the desired position of the permanent electrodes in the marks of the previous skin punctures for guidance. For the first trigeminal branch, choose a position on the lateral side of the forehead at which to puncture the skin, roughly 10 centimeters lateral and one centimeter above the medial border of the eyebrow.For the second trigeminal branch, choose a position that is located roughly one centimeter anterior to the tragus. Do not perform a skin puncture two centimeters or more anterior to the tragus to spare facial nerve fibers from injury. For the third trigeminal branch, choose a position that is located roughly one centimeter anterior and four centimeters below the tragus.Correct planning of electrode insertion is crucial to the success of this technique as the parasthesia provoked by the stimulation should cover the entire painful area. Use a 14-gauge Tuohy needle to perform a skin puncture at a previously marked position. As the subcutaneous tissue of the facial area is thinner than on other body parts, make sure to stay half a centimeter below the skin surface to prevent skin perforation or direct muscle stimulation.Make a one centimeter-long vertical incision in the supra-auricular area. And form a small subcutaneous pocket. Take the stylets from the Tuohy cannulas and subcutaneously tunnel them from the site of the skin puncture to the supra-auricular incision.Insert another Tuohy cannula to subcutaneously tunnel from the supra-auricular incision to the site of the skin puncture. And then insert the electrodes into the Tuohy cannula with the contacts located in the painful area. Remove the Tuohy cannulas and the electrode stylets.And insert the distal end of the electrode into the cannula. Remove the Tuohy cannula while using forceps to keep the electrode in place. Then use a 3-0 non-absorbable silk suture to fix the electrode to the muscle fascia to prevent electrode dislocation.Next, perform a six centimeter long infraclavicular incision and manually form a subcutaneous pocket to house the IPG. Use bipolar electrical forceps to coagulate any bleeding vessels. Insert a tunneling spear into the infraclavicular incision and subcutaneously tunnel behind the ear towards the supra-auricular incision.Make a small retroauricular incision for the spear to exit the skin. Then, tunnel with a second spear from the supra-auricular to the retroauricular incision. Remove the spear stylets.And insert the electrodes until the electrodes are buried in the subcutaneous tissue without any loops or kinks. After tunneling the electrodes to the retroauricular incision, tunnel them from here to the infraclavicular incision. Then remove the spear by pulling it out of the infraclavicular incision while using forceps to keep the electrodes in place.Connect the electrodes to the IPG. And use torque screws to secure them. Use a non-absorbable 3-0 silk suture to suture the IPG to the pectoralis muscle fascia to prevent IPG dislocation.Perform skin closure with absorbable 3-0 subcutaneous sutures and non-absorbable 3-0 cutaneous sutures in the facial area. And absorbable 3-0 intracutaneous sutures at the site of the IPG. Then disinfect all wounds.Clean the surgical field with saline. And apply sterile draping. Carry out post-operative care according to the text protocol.In one case series, 10 patients who suffered from pain from the conditions listed in this table underwent test stimulation for subcutaneous trigeminal nerve field stimulation, or sTNFS, and received permanent implantation of electrodes and an IPG. Following an 11-month follow-up, eight of the 10 patients responded to the therapy with pain reduced from 9.3 to 0.75 on the Visual Analog Scale. In another recently published series, eight patients were tested with sTNFS.After a mean follow-up of 15.2 months, six of the eight patients proceeded to permanent implantation. And according the VAS, pain was reduced from 8.5 to 1.4 points. The series is also the first to describe a 73%reduction in the mean number of painful daily attacks.The chart shown here was all patients with permanent implantations treated with sTNFS. A mean reduction of 6.8 VAS points and the mean reduction of 12.2 in the number of daily attacks was achieved. Trial electrode placement takes roughly 15 minutes.The surgery for permanent implantation can be performed within one hour and patients can be discharged on the next day. Subcutaneous trigeminal nerve field stimulation can provide a sustained therapeutic effect on both pain intensity and frequency of painful attacks. The amount of pain medication and its side effects can then be reduced.After watching this video, you should have a good understanding of how to perform trial electrode placement and permanent implantation surgery for subcutaneous trigeminal nerve field stimulation.

subcutaneous-trigeminal-nerve-field-stimulation-for-refractory-facial

Research

JoVE Journal

Medicine

18.5K Views.  University Hospital Heidelberg. The overall goal of this surgical intervention is to treat patients with chronic therapy-resistant and neuropathic trigeminal pain using minimally invasive subcutaneous nerve field stimulation as a method of neuromodulation. This method can help treat patients with therapy-resistant chronic trigeminal pain such as trigeminal neuralgia or post-therapeutic trigeminal neuropathy who have failed conservative and standard surgical treatment. The main advantage of this technique is that it is minim...