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Painful Diabetic Neuropathy clinical trials

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NCT ID: NCT05993871 Active, not recruiting - 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: NCT05985291 Recruiting - Clinical trials for Painful Diabetic Neuropathy

BurstDR Stimulation for Painful Diabetic Neuropathy

Start date: July 3, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.

NCT ID: NCT05937984 Not yet recruiting - Clinical trials for Painful Diabetic Neuropathy

Treatment for Painful Diabetic Neuropathy

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Painful diabetic neuropathy (pDN) occurs in a subset of diabetic patients, and is characterize by burning, shooting, and electric shock-like pain in the arms and legs. This represents a major health crisis, given the increasing prevalence of pDN and the significant impact it has on quality of life. However, there is limited evidence of effective therapies for pDN pain relief. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation that may be a promising therapy for pDN. Previous research has shown that rTMS reduces neuropathic pain in pDN (1, 2, 3). While this is promising, it is important to note that rTMS is effective for ~50% of patients with neuropathic pain. (4, 5). Recent advancements in rTMS technology have created the opportunity for remarkable strides in the effectiveness of this potential therapy. This new development called controlled pulse parameter TMS (cTMS) increases the magnitude and longevity of TMS-induced effects. Although not tested in chronic pain, cTMS possess the power to make transformative changes in pDN, potentially yielding greater and widespread improvements in pain. The overarching goal of the proposed research is to assess the effects of a 5-day cTMS stimulation protocol on measures of pain and neurological function in individuals with pDN. 1. Kwak S, Choi SG, Chang GS, & Yang MC (2022). Short-term Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain. Pain Physician, 25(2), E203-E209. 2. Abdelkader AA, Gohary AME, Mourad HS, & Salmawy DAE (2019). Repetitive tms in treatment of resistant diabetic neuropathic pain. Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 55(1). 3. Onesti E et al. (2013). H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. European Journal of Pain (United Kingdom), 17(9). 4. Attal N et al. (2021). Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain, 144(11). 65. Dongyang L et al. (2021). Posterior-superior insular deep transcranial magnetic stimulation alleviates peripheral neuropathic pain - A pilot double-blind, randomized cross-over study. Neurophysiologie Clinique, 51(4).

NCT ID: NCT05777317 Recruiting - Clinical trials for Painful Diabetic Neuropathy

Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

PDN-SENSORY
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.

NCT ID: NCT05754190 Recruiting - Chronic Pain Clinical Trials

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA

Start date: June 20, 2023
Phase:
Study type: Observational

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

NCT ID: NCT05624762 Recruiting - Clinical trials for Painful Diabetic Neuropathy

The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.

NCT ID: NCT05620225 Active, not recruiting - Neuropathic Pain Clinical Trials

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).

NCT ID: NCT05480228 Recruiting - Clinical trials for Painful Diabetic Neuropathy

EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

EN21-01
Start date: September 21, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.

NCT ID: NCT05476276 Recruiting - Clinical trials for Painful Diabetic Neuropathy

EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy

Start date: September 21, 2022
Phase: Phase 2
Study type: Interventional

This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol.

NCT ID: NCT05118217 Not yet recruiting - Clinical trials for Diabetic Peripheral Neuropathy

Microvascular Dysfunction in Diabetic Peripheral Neuropathy

Start date: November 18, 2021
Phase:
Study type: Observational

This study primarily seeks to evaluate dysfunction of small blood vessels and their linkage to dysfunction of nerves in people with Type 2 Diabetes. The purpose of this research is to explore some of the underlying pathophysiology of diabetic peripheral neuropathy, particularly painful diabetic peripheral neuropathy. The pain experienced by individuals with painful diabetic peripheral neuropathy is severe and associated with low quality of life. The pain does not typically respond well to pharmacological management. The processes underpinning the sources of pain are poorly understood, consequently only around a third of patients benefit from existing treatments. Some historic research on the sources of pain suggest the retention of the ability to reduce blood flow in small vessels may underpin these pain pathways. This research aims to explore this possibility, looking at the nerve-linked response in small vessels with a flickering light within the eye. Participants will complete three or four questionnaires: one demographic, two to aid with stratifying participants into groups concerning symptoms of neuropathy and an additional questionnaire if participants are stratified to the painful DPN group. A basic neurological examination of the feet will follow. Basic measurements of height, weight and blood pressure will be recorded for each participant. The primary sites of measurement of this small vessel dysfunction will be the eye and the foot investigated in a non-invasive manner. A bright flickering light will be shone into participants eyes, with the reaction of small vessels recorded. Sensors will also be placed on the feet and chest of participants and warmed to ~44C. An image will be taken of participants eyes to measure nerve layer thickness and an area of skin on the forearm will be illuminated to measure for levels of a metabolic marker. A picture of the eye will also be taken to determine nerve layer thickness.