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79 active trials for Neuropathic Pain

Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain

Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is largely treated with opiate narcotics, much as was done in the Civil War. In addition to their high abuse liability and dependence potential, only 30 40% of chronic pain patients declare they receive satisfactory (>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently, there is a critical need for new treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain. The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) on self-reported pain and the brain s response to pain. This will be done in a cohort of patients recruited from the community as well as Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).

Start: June 2020

Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain

The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.

Start: January 2021

Effectiveness of Ketamine Administered by Mesotherapy in Complex Regional Pain Syndrome Type 1 (CRPS1)

Complex Regional Pain Syndrome type 1 (CRPS1) is a disabling pain syndrome. Its definitive treatment has not been established and the results of current treatments are often unsatisfactory. The prognosis is difficult to establish because the vast majority of CRPS regresses within a few weeks. However, some forms are hyperalgesic with a major chronic painful picture, very debilitating and responding poorly to treatments with possible permanent sequelae. The management of CRPS remains difficult and unsatisfactory and is symptomatic, multidimensional and multidisciplinary involving medical, paramedical and socio-professional workers. The priority therapeutic objectives are analgesia, maintenance or gain of joint range and maintenance or restoration of motor functions. This treatment is not the subject of a consensus and its implementation is sometimes the responsibility of specialized centers such as "pain relief" centers or even Physical Medicine and Rehabilitation (MPR) structures. Previous studies using ketamine as a treatment for CRPS1 show encouraging results with a decrease in neuropathic pain. Ketamine is a low dose pain reliever. Ketamine has been studied as an adjuvant for the treatment of chronic pain, particularly neuropathic pain. The results suggest that ketamine decreases pain intensity and reduces opioid reliance when used as an adjunct to chronic and acute pain. Ketamine is believed to have a greater analgesic effect in patients with CRPS1 compared to other chronic pain syndromes. In these studies, ketamine was used intravenously, subcutaneously, orally, intranasally, or topically. Mesotherapy allows microdose local treatment to be carried out limiting side effects, ensuring compliance and easy to implement. The injected solutions often contain a local anesthetic (procaine or lidocaine). It allows better local tolerance from the start of treatment. In addition, through its vasodilator effect on the microcirculation, it increases the effectiveness and tolerance of other injected products. There are no studies using ketamine administrated by mesotherapy. Based on the scientific literature, there are good reasons to believe that this treatment could be effective on the neuropathic pain of CRPS1 and well tolerated.

Start: September 2021

Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, researchers want to learn more about how SCS affects pain processing and relieves pain. The researchers will examine multiple forms of SCS in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

Start: July 2021

Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Brief summary: This single-arm, pilot clinical investigation aims to evaluate Mindful SensoriMotor Therapy (MSMT) enhanced with brain modulation as a treatment of pain due to sensorimotor impairment, such as Phantom Limb Pain (PLP). MSMT consists of consciously retraining the motor and sensory networks used by the missing limb via myoelectric pattern recognition and haptic feedback. In this trial, we further enhance the effect of MSMT by brain modulation, transcranial Direct Current Stimulation (tDCS).

Start: August 2021

Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with comprehensive medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.

Start: July 2020

The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain

The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.

Start: December 2018

Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.

Start: May 2021

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block

The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.

Start: May 2021

rTMS Efficacy Coupled With Mirror Therapy

Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

Start: September 2021

CORTICAL STIMULATION BY DIRECT CURRENT FOR THE TREATMENT OF CHRONIC PAIN : PILOT-STUDY OF A STIMULATION DEVICE AT HOME

The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home. It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014). No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.

Start: February 2015

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI

In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC scales.

Start: October 2019

Pain, Inflammation, and Cannabis in HIV

This study will test how research vouchers for medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain.

Start: July 2021

Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication). The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression. In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.

Start: January 2021

Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury

Neuropathic pain is a common complication following spinal cord injury (SCI) that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Nabilone and an anti-inflammatory diet are two treatments that may provide pain relief while being better tolerated. This study will evaluate the benefits of these treatments for neuropathic pain after SCI. Study participants will receive either an anti-inflammatory diet, nabilone or a placebo (alone or in combination) for 12 weeks. It is expected that an anti-inflammatory diet and nabilone will significantly decrease pain intensity and improve function. The combination of both treatments together is expected to have a greater effect than each alone.

Start: November 2021

Screening for the Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR FAP)

An International, multicenter, epidemiological observational study investigating the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in participants with small fiber polyneuropathy of no obvious etiology.

Start: December 2016

Posterior-superior Insula Deep Brain Stimulation in Refractory Peripheral Neuropathic Pain Patients

This study evaluates the long term pain relief after deep brain stimulation on posterior-superior insula (PSI) in patients with refractory peripheral neuropathic pain who responded to real but not to sham non-invasive stimulation by deep repetitive transcranial magnetic stimulation - PSI-drTMS.

Start: July 2019

Evaluation of the Effect of Neuropathic Pain on Quality of Life in Rheumatoid Arthritis Patients

Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide. Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain,defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain,such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia. The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. In order to distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analog scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire). The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life.

Start: April 2021

Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Investigators aim to identify the key phenotypes (biological, psychological, genetic) involved in the transition from acute to chronic neuropathic pain (NP) by comparison of the neuropathic pain phenotypes and genomics of patients developing NP or not under similar nerve injury conditions. The cohort is part of a previous prospective study of 1000 patients operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve resection during operation with or without persistent pain and additional 50 patients with pain, but no nerve resection during operation. Patients fill in questionnaires and a detailed sensory examination, cognitive tests, and a cold water test with autonomic nervous system monitoring are performed during the research visit. A selected group of patients undergo quantitative sensory testing (QST).

Start: October 2014

Mechanisms and Treatment of Post-amputation Neuropathic Pain

Phantom and residual limb pain are types of peripheral neuropathic pain that are difficult to treat and where the underlying mechanisms are still not fully understood. Repetitive transcranial magnetic stimulation (rTMS) of the motor cortex is an increasingly studied technique for the treatment of neuropathic pain and has shown modest effects in pain intensity reduction for the treatment of neuropathic pain. Newer rTMS coils provide the opportunity to stimulate larger brain areas, which could provide a better treatment option compared to conventional coils. The aims of this study are to investigate whether the peripheral nervous system is a necessary driver of phantom limb pain and/or residual limb pain in patients with lower limb amputation using spinal anaesthesia, and to assess the analgesic efficacy of deep H-coil rTMS compared to sham stimulation in the same patients.

Start: April 2021