Treatment Trials

40 Clinical Trials for Various Conditions

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OnabotulinumtoxinA for Trigeminal Neuralgia
Description

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Conditions

Trigeminal Neuralgia

A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia
Description

The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified: 1. To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs). 2. To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

Conditions

Trigeminal Neuralgia

Comorbid Painful TMD Among Trigeminal Neuralgia
Description

An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

Conditions

Trigeminal Neuralgia, Temporomandibular Disorder, Myofascial Pain, Trigeminal Neuropathy

Trigeminal Neuralgia Electrophysiology
Description

The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.

Conditions

Trigeminal Neuralgia

An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients with Trigeminal Neuralgia.
Description

Trigeminal neuralgia (TN), also called "tic douloureux", is the most common form of craniofacial neuropathic pain and is considered the cause of one of the most painful afflictions known in medical practice. This study is designed to evaluate the efficacy and safety of 1.5mg - 3.5mg basimglurant in adults with TN.

Conditions

Trigeminal Neuralgia

Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.
Description

This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo. A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

Conditions

Trigeminal Neuropathy

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia
Description

This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1 (TGN).

Conditions

Trigeminal Neuralgia

MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
Description

The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.

Conditions

Trigeminal Neuralgia

Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
Description

The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.

Conditions

Facial Pain

Trial for Treatment Refractory Trigeminal Neuralgia
Description

The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with treatment refractory Trigeminal Neuralgia as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale between the two-week treatment phases.

Conditions

Trigeminal Neuralgia

Neurophysiologic Signatures of Trigeminal Neuralgia Pain
Description

Trigeminal neuralgia (TN) is an idiopathic pain disorder that is characterized by episodic attacks of intense facial pain, described as paroxysms of stabbing, electric, or explosive pain, and lasting for a few seconds or longer, often producing a tic-like facial movement, and can occur up to hundreds of times per day. This pain is known to be one of the worst pain conditions that a patient can suffer and has been called the "suicide disease". Given the severity of this disorder, determining the cause becomes essential for finding a cure. This project will study the cause of TN using a translational approach, which means the research project will be completed in both humans and animals. The investigators hypothesize that there are specific areas of the brain and spinal cord that will provide a "signature" center of activity. The study team will use state of the art magnetic resonance imaging (MRI) machines and other non-invasive brain activity measurements, including electroencephalography (EEG) to locate these centers in people with TN before and after their pain has started. Recent studies have investigated the effects of transcranial electrical stimulation (tES) for pain control. Transcranial electrical stimulation (tES) includes transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS). This approach is important because identifying similar regions neural activity will allow for us to study novel therapies in search of the cure for TN and this study has thus both basic and clinical neuroscience significance.

Conditions

Trigeminal Neuralgia (TN)

An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
Description

This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that receives the sham device. Subjects will be monitored for subjective criteria of pain and quality of life, as well as objective measurement of analgesic usage.

Conditions

Trigeminal Neuralgia

RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery
Description

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

Conditions

Trigeminal Neuralgia

Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia
Description

A placebo-controlled, single-blind study to evaluate the safety and preliminary efficacy of nasal carbon dioxide for the symptomatic treatment of classical trigeminal neuralgia.

Conditions

Trigeminal Neuralgia

Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
Description

IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from motor neurons. In addition it blocks the release of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C fibers involved in pain perception. This study is designed to see if Xeomin® is superior to placebo in the treatment of medically refractory trigeminal neuralgia (TN). Subjects will be asked to maintain an attack diary throughout the study. They will also be asked to attend 4 office visits; Visit 1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit and Visit 4- Final Visit. At the end of the study the active (Xeomin®) and placebo groups will be compared to see if one group had better relief than the other.

Conditions

Trigeminal Neuralgia

A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Description

The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures. The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.

Conditions

Trigeminal Neuralgia

A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Description

The investigators know little about how patients feel following radiosurgery treatment of trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important outcome measures for an individual patient; however, this has not been adequately assessed or followed. Multiple questions remain unanswered, including whether there is a correlation between patient satisfaction, the level of their current pain score, and the presence and degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of this study is to gather this information from the patients who received radiosurgery for trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree of facial numbness, and current pain score. This data will help the investigators understand outcomes that are important for patient satisfaction following treatment of a chronic pain syndrome.

Conditions

Trigeminal Neuralgia

Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Description

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring about pain relief and facial numbness, we are conducting a study in which brain MRI scans will be done following stereotactic radiosurgery to learn if there are any changes in the MRI scans that correlate with symptoms.

Conditions

Trigeminal Neuralgia

A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
Description

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

Conditions

Trigeminal Neuralgia

Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
Description

This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.

Conditions

Trigeminal Neuralgia

Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
Description

OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia. II. Evaluate the safety and tolerance of L-baclofen in these patients.

Conditions

Trigeminal Neuralgia

Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
Description

The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.

Conditions

Trigeminal Neuropathic Pain

Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
Description

The main goal of this study to integrate techniques producing images of the brain (also called neuroimaging techniques) with non-invasive brain stimulation to investigate factors that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).

Conditions

Trigeminal Neuropathic Pain

Trigeminal Evoked Responses to Improve Rhizotomy
Description

Trigeminal neuralgia (TGN) is a debilitating pain syndrome where electrical, shock- like jolts of pain affect the face. Trigeminal somatosensory evoked potentials (TSEPs) provide a promising modality for measuring the trigeminal sensory and nociceptive pathway by using peripheral stimulation of the trigeminal nerve (on the skin) and measuring low latency evoked potentials on the scalp (contralateral sensory cortex). While TSEPs have been measured in the past, it is not clear if implementing TSEPs into a routine neurosurgical rhizotomy procedure will be feasible. This is a prospective cohort study examining the feasibility of routinely performing TSEPs during rhizotomies for TGN.

Conditions

Trigeminal Neuralgia, Rhizotomy

Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
Description

The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. The primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. Another goal is to monitor and confirm the safety profile established in the migraine population, during previous Phase 3 trials.

Conditions

Trigeminal Neuralgia, Glossopharyngeal Neuralgia

Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
Description

A phenome-wide association study (PheWAS) identified an association between a loss of function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors. The objectives of the study will be to evaluate the efficacy and safety of guanfacine in combination with lidocaine for trigeminal nerve block procedures for pain management in trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in reducing acute pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected at specific time points after each injection.

Conditions

Trigeminal Neuralgia

New Formulation and Food Effect Study of BIIB074
Description

The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.

Conditions

Trigeminal Neuralgia (TN), Other Neuropathic Pain

Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
Description

This study is an open-label study to determine the feasibility of Motor Cortex Stimulation (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will be delivered by use of an electrode and pulse generator, which are FDA approved for spinal cord stimulation but are not approved for MCS. The study has as a single-arm design with the subject at baseline serving as a control for the response to MCS.

Conditions

Trigeminal Neuralgia (Burchiel Type I), Trigeminal Neuralgia (Burchiel Type II), Trigeminal Neuropathic Pain, Trigeminal Deafferentation Pain, Complex Regional Pain Syndrome (Types I and II, Involving the Upper Extremity), Glossopharyngeal Neuralgia, Upper Extremity Pain Due to Deafferentation of the Cervical Spine, Central Pain Syndromes

Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Description

Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.

Conditions

Chronic Neuropathic Pain, Post-Stroke Pain, Trigeminal Neuralgia, Nerve Injury, Spinal Cord Injuries, Pain, Postoperative, Complex Regional Pain Syndromes, Post-herpetic Neuralgia, Nerve Root Avulsion

Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
Description

The purpose of this study is to evaluate the safety and efficacy of intra-arterial (IA) delivery of Dexamethasone and Ketorolac into the arteries supplying the sphenopalatine ganglion (SPG) - a collection of neurons that plays an important role in headache disorders - in patients with refractory migraine, cluster headache and trigeminal neuralgia. All patients must fail standard treatments prior to enrollment in the trial.

Conditions

Chronic Migraine, Cluster Headache, Trigeminal Neuralgia