Deep Brain Stimulation for Trigeminal Neuralgia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Université de Sherbrooke
Disqualifiers: Mri contraindication, Procedure contraindication
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis. These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief. Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for patients with refractory trigeminal neuralgia who have failed at least three drugs, it is likely that you can continue your current medications.
What data supports the effectiveness of the treatment Deep Brain Stimulation for Trigeminal Neuralgia?
Deep Brain Stimulation (DBS) has shown promise in treating various types of intractable facial pain, including trigeminal neuralgia, by improving pain scores and quality of life in some patients. Although results can vary, DBS has been effective for chronic pain conditions that do not respond to other treatments.12345
Is deep brain stimulation generally safe for humans?
How is deep brain stimulation treatment different from other treatments for trigeminal neuralgia?
Deep brain stimulation (DBS) is unique because it involves surgically implanting electrodes to modulate brain activity, which is different from medications or less invasive procedures. It is often considered a last resort for patients whose pain does not respond to standard treatments, offering a novel approach by targeting specific brain areas to alleviate chronic pain.1251112
Eligibility Criteria
This trial is for adults over 18 with severe facial pain from trigeminal neuralgia that hasn't improved after trying at least three medications and one surgery. They must have an MRI showing a demyelinating lesion in the brainstem touching the trigeminal nerve.Inclusion Criteria
I am 18 years old or older.
My facial pain hasn't improved despite trying 3 drugs and 2 surgeries.
My MRI shows a lesion in the brainstem touching the trigeminal nerve.
Exclusion Criteria
Absolute contraindication to MRI
I have a health condition that makes the procedure unsafe for me.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Implantation of deep brain stimulation lead within the pontine lesion
Immediate post-surgery
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Regular visits (in-person and virtual)
Treatment Details
Interventions
- Deep brain stimulation (Neurostimulation Device)
Trial OverviewThe study tests deep brain stimulation (DBS) as a new method to relieve intense facial pain caused by trigeminal neuralgia with a pontine lesion, often seen in multiple sclerosis patients where other treatments failed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Deep brain stimulationExperimental Treatment1 Intervention
Implantation of deep brain stimulation lead within the pontine lesion
Deep brain stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Trigeminal neuralgia
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Trigeminal neuralgia
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Trigeminal neuralgia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier Universitaire de Sherbrooke (CHUS)Sherbrooke, Canada
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Who Is Running the Clinical Trial?
Université de SherbrookeLead Sponsor
References
Functional MRI-Guided Motor Cortex and Deep Brain Stimulation for Intractable Facial Pain: A Novel, Personalized Approach in 1 Patient. [2023]Facial neuropathic pain syndromes such as trigeminal neuralgia are debilitating disorders commonly managed by medications, vascular decompression, and/or ablative procedures. In trigeminal neuralgia cases unresponsive to these interventions, trigeminal deafferentation pain syndrome (TDPS) can emerge and remain refractory to any further attempts at these conventional therapies. Deep brain stimulation (DBS) and motor cortex stimulation are 2 neuromodulatory treatments that have demonstrated efficacy in small case series of TDPS yet remain largely underutilized. In addition, functional MRI (fMRI) is a tool that can help localize central processing of evoked stimuli such as mechanically triggered facial pain. In this study, we present a case report and operative technique in a patient with TDPS who underwent fMRI to guide the operative management and placement of dual targets in the sensory thalamus and motor cortex.
Deep Brain Stimulation for Facial Pain. [2021]Electro-modulation of subcortical deep brain structures by surgically implanted electrodes is now standard evidence-based treatment for movement disorders such as Parkinson's disease and essential tremor and is approved for dystonia and obsessive-compulsive disorder under a humanitarian exemption. Historically, deep brain stimulation (DBS) for multiple indications has demonstrated acceptable complication rates, rare mortality, and reducing morbidity as the technology and the techniques of its application have advanced. DBS for the amelioration of pain has been performed since the early 1950s, and became widely used in the 1970s, when targeting the somatosensory thalamus was shown to be efficacious for intractable pain syndromes including facial pain. The technique fell out of favour in the late 1990s after 2 multicentre trials failed to meet end-point criteria. Since these trials, DBS for pain has remained for investigational or "off-label" use. Criticisms from previous literature have involved unsuitability of patient selection, as well as inconsistencies in neurosurgical technique. Clinical success with DBS for facial pain has been for the treatment of a variety of chronic neuropathic and nociceptive pain syndromes; including trigeminal neuropathy, post-herpetic neuralgia, deafferentation facial pain, "atypical" facial pain, cluster headaches and other trigeminal autonomic cephalalgias, as well as head and neck pathologies, most often which have been resistant to all other 1st- and 2nd-line medical and surgical treatments, when DBS has become a "last treatment option." An enhanced understanding of the mechanisms of action of DBS for pain will enhance outcome, and appropriately prescribe evolving novel nuclear brain targets.
Deep brain stimulation for neuropathic cephalalgia. [2008]The aim of this study was to determine the efficacy of deep brain stimulation (DBS) in the treatment of various types of intractable head and facial pains. Seven patients underwent the insertion of DBS electrodes into the periventricular/periaqueductal grey region and/or the ventroposteromedial nucleus of the thalamus. We have shown statistically significant improvement in pain scores (visual analogue and McGill's) as well as health-related quality of life (SF-36v2) following surgery. There is wide variability in patient outcomes but, overall, DBS can be an effective treatment. Our results are compared with the published literature and electrode position for effective analgesia is discussed.
Update on neurosurgical treatment of chronic trigeminal autonomic cephalalgias and atypical facial pain with deep brain stimulation of posterior hypothalamus: results and comments. [2019]The objective of this study is to describe the therapeutic effect and the technical and surgical problems of deep brain stimulation (DBS) of the posterior hypothalamus over seven years, for treatment of chronic trigeminal autonomic cephalalgias and atypical facial pain. We report a surgical series of 20 patients that underwent DBS of the posterior hypothalamus. This series includes 16 patients with chronic cluster headache (CH), one patient with short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and three patients with atypical facial pain. All patients of this series were resistant to any pharmacological and conservative treatment. The stimulated target was the same in the whole series even though stereotactic coordinates of the target referred to the midcommissural point differ slight in the Y anteroposterior value due to individual anatomical variability. The commissures based reference system was adapted to individual anatomical landmarks of the brainstem adding to the registration a third reference point below the commissural plane. The stimulation parameters of unipolar stimulation were similar in the whole series: 180 Hz, 60 mus, 1-3 V. In the CH series, at five years follow-up the percentage of total number of days free from pain attacks improved from 1%-2% to 71%. Ten patients of this series had a complete and persistent pain-free state at 18 months follow-up and the patient with SUNCT has complete pain relief. In the three patients with atypical facial pain, the neurostimulation procedure was absolutely unsuccessful. DBS of the posterior hypothalamus produced a significant and marked reduction of pain bouts in CH patients and in the SUNCT patient. The attempts to treat atypical facial pain in three patients failed.
Drug therapy of trigeminal neuralgia. [2006]Trigeminal neuralgia is a chronic pain syndrome of still unestablished origin. Its diagnosis depends on clinical grounds. Drug therapy initially helps a great majority of patients. The choice of drugs is quite large, but truly effective compounds with a tolerable side effect profile remain few. Carbamazepine (or oxcarbazepine) and lamotrigine appear to be the most effective, followed by baclofen. Several patients require further nonpharmacological treatment for which no evidence-based recommendation is possible. In the future, neuromodulation may be brought to bear, as in other chronic pain syndromes.
Failure of chronic pallidal stimulation in dystonic patients is a medical emergency. [2022]Deep brain stimulation (DBS) therapy is a continually expanding field of functional neurosurgery for the treatment of movement disorders and neuropathic pain. However, occurrence of adverse events related to implanted hardware cannot be ignored, particularly in patients with dystonic conditions. We report on two such patients who required emergency hospital admission and pulse generator re-implantation following sudden and unexpected cessation of DBS effectiveness resulting from battery failure.
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]The number of deep brain stimulation (DBS) procedures is rapidly rising as well as the novel indications. Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it.
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.
Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature. [2019]To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus on the reporting of such AEs.
Complications of Deep Brain Stimulation for Movement Disorders: Literature Review and Personal Experience. [2023]The contemporary technique of deep brain stimulation (DBS) is very effective for management of movement disorders-including Parkinson's disease, generalized dystonia, and tremors-and has also been successfully applied for novel indications (e.g., intractable epilepsy and chronic pain). As a result, growing numbers of DBS procedures have been performed worldwide; correspondingly, the incidence of associated morbidity has also increased. All complications of DBS can be divided into those associated with (1) the surgical procedure, (2) the device itself, and (3) the applied electrical stimulation. On the basis of an analysis of the available literature and the personal experience of the author, it may be concluded that implantation of a DBS device is a relatively safe procedure accompanied by very low risks of major morbidity or a permanent neurological deficit. Nevertheless, awareness of the possible complications and application of appropriate preventive measures for their avoidance are very important for providing safe and effective treatment.
Neuropathic pain and deep brain stimulation. [2021]Deep brain stimulation (DBS) is a neurosurgical intervention the efficacy, safety, and utility of which are established in the treatment of Parkinson's disease. For the treatment of chronic, neuropathic pain refractory to medical therapies, many prospective case series have been reported, but few have published findings from patients treated with current standards of neuroimaging and stimulator technology over the last decade . We summarize the history, science, selection, assessment, surgery, programming, and personal clinical experience of DBS of the ventral posterior thalamus, periventricular/periaqueductal gray matter, and latterly rostral anterior cingulate cortex (Cg24) in 113 patients treated at 2 centers (John Radcliffe, Oxford, UK, and Hospital de São João, Porto, Portugal) over 13 years. Several experienced centers continue DBS for chronic pain, with success in selected patients, in particular those with pain after amputation, brachial plexus injury, stroke, and cephalalgias including anesthesia dolorosa. Other successes include pain after multiple sclerosis and spine injury. Somatotopic coverage during awake surgery is important in our technique, with cingulate DBS under general anesthesia considered for whole or hemibody pain, or after unsuccessful DBS of other targets. Findings discussed from neuroimaging modalities, invasive neurophysiological insights from local field potential recording, and autonomic assessments may translate into improved patient selection and enhanced efficacy, encouraging larger clinical trials.
Peripheral Nerve Stimulation for Facial Pain Using Conventional Devices: Indications and Results. [2021]Trigeminal branch stimulation is a type of peripheral nerve stimulation (PNS) used to treat a variety of craniofacial pain disorders. Common indications include trigeminal neuralgia, trigeminal neuropathic pain, trigeminal deafferentation pain, trigeminal postherpetic neuralgia, supraorbital neuralgia, and migraine headaches. Supraorbital and infraorbital arrays are the most common electrode configurations, although preauricular, mandibular branch, and subcutaneous peripheral nerve field stimulation arrays have also been described. Trigeminal branch stimulation may be used as a stand-alone neuromodulation therapy or it may be combined with occipital nerve, sphenopalatine ganglion, or Gasserian ganglion stimulation to treat more complex pain patterns. Consistent with other forms of PNS, trigeminal branch stimulation is a minimally invasive, safe, and straightforward method of treating medically refractory neuropathic pain.