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Small Fiber Neuropathy clinical trials

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NCT ID: NCT06183008 Not yet recruiting - Clinical trials for Small Fiber Neuropathy

IVIG in Painful Sensory Neuropathy

Start date: February 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.

NCT ID: NCT05993871 Completed - Clinical trials for Diabetic Neuropathies

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

Start date: January 1, 2023
Phase:
Study type: Observational

The aim of work is to study the clinical, electrodiagnostic and neurosonographic characteristics of diabetic patients with small fiber neuropathy in the Egyptian population, and to evaluate both the diagnostic and the prognostic impact of the studied factors on the neuropathy severity and quality of life.

NCT ID: NCT05921097 Enrolling by invitation - Diabetes Clinical Trials

Comparison of Histamine and Local Heating for Evoking the Axon-reflex Flare Response in Diabetes

HistaHeat
Start date: June 17, 2023
Phase:
Study type: Observational

Diabetic peripheral neuropathy is the most common complication to diabetes mellitus affecting as much as 50% of the population with diabetes. Symmetrical sensory neuropathy is by far the most common pattern, which often progress slowly over many years, although some individuals experience faster and more severe courses. Despite the frequent occurrence, the causes of diabetic peripheral neuropathy are largely unknown, which is reflected in the fact that no disease-modifying treatments are available for preventing, treating or even halting the progression of the disease. The consequences can be dire, as neuropathy frequently leads to foot ulcers, amputations or intolerable neuropathic pain in the lower extremities. Sensory loss may go completely undetected in diabetes, as there often are literally no symptoms. For many individuals, the development of diabetic peripheral neuropathy can therefore proceed completely unnoticed, making regular screening the most important tool for diagnosing the condition. Unfortunately, unlike nephropathy or retinopathy, diabetic peripheral neuropathy is not easily screened for, as the condition lacks reliable markers for early- or progressing disease. Therefore, screening for diabetic peripheral neuropathy currently revolves around diagnosing loss of protective sensation, judged by the inability to feel vibration or light touch. However, in their most recent guidelines, the American Diabetes Association has included screening for small fibre neuropathy using either the cold- and heat perception thresholds or pinprick as a clinical standard. Although this acknowledgement of the importance of assessing not only large- but also small nerve fibres is a huge step towards early detection of diabetic peripheral neuropathy, the overriding issue of insensitive, unreproducible, and inaccurate bedside tests for small nerve fibres remains. While cold- and heat perception and pinprick sensation are indeed mediated by small nerve fibres, the sensitivity of these methods, outside of extreme standardization only achievable in dedicated neuropathy research-centres, remain poor and not usable on an individual level. This lack of sensitivity has also become apparent in several large clinical trials, where the methods have continuously failed as robust clinical endpoints. Due to this, the hunt for a sensitive and reproducible method for adequate assessment of the small nerve fibres have begun. Amongst several interesting methods, two have gained particular interest (corneal confocal microscopy and skin biopsies with quantification of intra-epidermal nerve fiber density), due to their diverse strengths, although clinical application is currently limited to a few specialized sites. Furthermore, both methods suffer several inherent issues including that fact that they only provide information about the structure of the nerves and not the function. One method to assess the function of small cutaneous C-fibers is the assessment of the axon reflex flare response using laser doppler imaging (LDI) or Full-field laser perfusion imaging (FLPI), which has classically been studied using local heating. Unfortunately, this method is limited in clinical usage due to time-consumption. The investigators recently published an alternative method using a simple skin-prick application of histamine to evoke the response, which reduced the examination-time markedly. Before claiming the method to be a better alternative, the investigators do however need to prove that the method is as good as the original. In addition to the direct comparison of the histamine-induced and the heating-induced axon-reflex flare response the study will also assess spatial acuity in the same cohort as a secondary aim. Spatial acuity is considered as a measure of the sensory systems ability to code spatial information regarding an external stimulus. To investigate the spatial acuity, the 2-point discrimination task (2PDT) is often used. Spatial acuity has been shown to be impaired in several chronic pain condition. Additionally, it has been shown that the 2PDT may be a useful tool to understand the sensory changes in diabetes[8].

NCT ID: NCT05798949 Recruiting - Clinical trials for Small Fiber Neuropathy

Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

Small fiber neuropathy (SFN) is a condition that is dominated by invalidating neuropathic pain. Pharmacological neuropathic pain treatment is often disappointing, since pain reduction is mostly slight and side effects can be debilitating. Although neuropathic pain is caused by a lesion of the somatosensory system, also psychological factors, such as fear and catastrophizing, appear to play a role in the origin and maintenance of disability in chronic pain. Rehabilitation based on pain education and cognitive behavioral treatment including elements of acceptance and commitment therapy, exposure in vivo or graded activity can be performed to influence these factors. To date no specific rehabilitation programs are available for patients diagnosed with SFN.

NCT ID: NCT05645874 Recruiting - Cerebral Palsy Clinical Trials

Reference Values of Intraepidermal Nerve Fiber Density in Children and Small Fiber Neuropathy in Neurometabolic and Neurodevelopmental Disorders in Children

SFN_children
Start date: January 1, 2022
Phase:
Study type: Observational

Background: Small-Fiber-Neuropathy describes the degeneration of mildly or unmyelinated nerve fibers and causes neuropathic pain and autonomic dysfunction. Gold standard for the diagnosis is a small skin punch biopsy from the lower leg and the histological quantification of the intraepidermal nerve fiber density (IENFD). In children, the normal IENFD has not been systematically assessed and normal reference values are needed. In Parkinson´s disease, the neurodegeneration also affects the peripheral nerves and SFN is present already in the early stages. Whether neurodevelopmental disorders (NDDs) in childhood are likewise associated with SFN is largely unknown. The IENFD is age-dependent and declines with age. Aims: In this study, we are establishing the reference values for the physiological IENFD in children from 0-18 years. Moreover, we are investigating if children with NDDs have a reduced IENFD and if SNF is a clinically relevant cause of pain and autonomic dysfunction.

NCT ID: NCT05546138 Not yet recruiting - Type 1 Diabetes Clinical Trials

Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

NeuroPredict
Start date: October 1, 2023
Phase:
Study type: Observational

Predicting early onset neuropathy in people with type 1 diabetes

NCT ID: NCT05389566 Recruiting - Diabetes Clinical Trials

Diabetes, Falls, and Fractures

DIAFALL
Start date: May 6, 2022
Phase:
Study type: Observational

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

NCT ID: NCT05380804 Completed - Clinical trials for Small Fiber Neuropathy

Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

Start date: January 4, 2021
Phase:
Study type: Observational

Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. The prevalence of neurological involvement varies widely from 10% to 60% in different series. Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in patients with pSS and has an important clinical importance because it cannot be detected by routine electrophysiological studies. Various methods can be used in the detection of SFN, and cutaneous silent period (CSP) measurement is gaining popularity recently due to its non-invasiveness and practical fashion. In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in patients with pSS and in the healthy population and to reveal its relationship with clinical parameters.

NCT ID: NCT04927832 Recruiting - Clinical trials for Unexplained Pain Syndrome

Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes

SUDOCU
Start date: July 6, 2017
Phase: N/A
Study type: Interventional

Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage. SUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function. With quantitative and reproducible results, SUDOSCAN allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management. SUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN. The purpose of the study SUDOCU is to assess the prevalence of small fiber neuropathies (SFN) in patients with systemic autoimmune pathologies or unexplained pain syndrome.

NCT ID: NCT04872452 Withdrawn - Clinical trials for Small Fiber Neuropathy

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Start date: December 22, 2023
Phase: N/A
Study type: Interventional

This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.