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Trigeminal Neuralgia clinical trials

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NCT ID: NCT06315790 Recruiting - Clinical trials for Trigeminal Neuralgia

Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia

Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.

NCT ID: NCT06213155 Recruiting - Clinical trials for Trigeminal Neuralgia

A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia

CryoGem
Start date: January 2024
Phase: N/A
Study type: Interventional

The CryoGem Trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with trigeminal neuralgia. Trigeminal neuralgia is a condition that causes severe facial pain. In this study, we want to find out if the freezing technique is effective and safe. We will do this by comparing two groups of adults with trigeminal neuralgia. One group will receive the actual treatment, while the other group will receive a fake treatment called a sham. Neither the participants nor the assessors will know which group they are in (this is called a blinded study). For the next four weeks, participants in both groups will continue recording their headaches without knowing which treatment they are receiving. After this initial period, there will be an extension period where all participants can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique is a viable treatment option for trigeminal neuralgia. Our main goal is to see how many people in each group have a significant reduction in pain (at least 75% less pain). We will also record other important information about the participants. We are looking to recruit up to 24 adults with trigeminal neuralgia to take part in this study. All participants will keep a daily diary for two weeks to track their headaches before starting the treatment. Then, they will be randomly assigned to either the treatment group or the sham group.

NCT ID: NCT05810428 Recruiting - Virtual Reality Clinical Trials

Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects

Start date: April 6, 2023
Phase: N/A
Study type: Interventional

Trigeminal neuralgia (TN) is the most common cause of facial pain. Medical treatment is the first therapeutic choice whereas surgery, including Gamma Knife radiosurgery (GKRS), is indicated in case of pharmacological therapy failure. However, about 20% of subjects lack adequate pain relief after surgery. Virtual reality (VR) technology has been explored as a novel tool for reducing pain perception and might be the breakthrough in treatment-resistant cases. The investigators will conduct a prospective randomized comparative study to detect the effectiveness of GKRS aided by VR-training vs GKRS alone in TN patients. In addition, using MRI and artificial intelligence (AI), the investigators will identify pre-treatment abnormalities of central nervous system circuits associated with pain to predict response to treatment. The investigators expect that brain-based biomarkers, with clinical features, will provide key information in the personalization of treatment options and bring a huge impact in the management and understanding of pain in TN.

NCT ID: NCT05738096 Recruiting - Clinical trials for Trigeminal Neuralgia

Trigeminal Evoked Responses to Improve Rhizotomy

Start date: November 1, 2023
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT05685797 Recruiting - Clinical trials for Trigeminal Neuralgia

Biomarker Study in Patients With Trigeminal Neuralgia

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with primary trigeminal neuralgia (TN).

NCT ID: NCT05677243 Recruiting - Clinical trials for Trigeminal Neuralgia

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

NATURE
Start date: December 15, 2021
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

NCT ID: NCT05615714 Recruiting - Clinical trials for Trigeminal Neuralgia

Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial)

FreeST
Start date: October 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Study type: Prospective, double-blinded, double arm, cross-over, randomized controlled clinical trial. Brief protocol: Postoperative week 0-2 -> Conventional parameters (parameters tested during trial period) Postoperative week 2-6 -> Sham stimulation (2 weeks) and paresthesia-free stimulation (2 weeks) double-blind crossover design Postoperative week 6 - month 12 -> Parameters that patients feel more benefit from

NCT ID: NCT05593237 Recruiting - Pain, Postoperative Clinical Trials

Transcranial Magnetic Stimulation for Chronic Neuropathic Pain

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05328661 Recruiting - Clinical trials for Trigeminal Neuralgia

Pathophysiological Mechanisms of Trigeminal Neuralgia - Neurophysiological Assessment of the Blink-reflex

TNBR
Start date: May 1, 2021
Phase:
Study type: Observational

This study aims to increase the understanding of the pathophysiology of trigeminal neuralgia by investigating the potential association between blink reflex abnormalities and phenotypical traits e.g. clinical characteristics and neuroimaging findings.

NCT ID: NCT05269472 Recruiting - Clinical trials for Trigeminal Neuralgia

Trigeminal Neuralgia Electrophysiology

Start date: April 4, 2022
Phase:
Study type: Observational

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.