Active clinical trials for "Peripheral Nervous System Diseases"

Diabetic peripheral neuropathy (DPN) is one of the microvascular complications of diabetes mellitus. This can lead to painful and costly clinical sequelae such as foot ulcers, amputation, and neuropathic pain. There are several novel diagnostic methods available for complementary to clinical assessment and may help in the early detection of DPN. However, treatments for DPN and painful DPN are limited. We will conduct a pilot, single-center, randomized controlled trial in patients with DPN to verify the effect of the laser acupuncture on DPN. With designed inclusion and exclusion criteria, 30 eligible participants will be randomized with 1:1 allocation ratio to the following two groups:(1) the laser acupuncture group (N=15), (2) the sham laser acupuncture group (N=15). Each participant will receive 24 interventions within 8 weeks, three times per week. Participants follow the laser acupuncture protocol in our study. All participants will be clinically assessed by (1) Michigan Neuropathy Screening Instrument (MNSI), (2) questionnaires (BPI(SF)-DPN) for diabetic neuropathic pain assessment, and (3) nerve conduction test. This research project will validate our novel preliminary findings demonstrating neuroprotective effects of laser acupuncture treatment. Importantly, our data are expected to elucidate how laser acupuncture induces neuroprotection in the clinical setting and provide a scientific base for developing new approaches in the treatment of DPN.

Rationale: An average of 30% of adult cancer survivors suffers from chemotherapy-induced peripheral neuropathy (CIPN) ≥ 6 months after completion of chemotherapy, and their quality of life (QoL) is strongly affected due to these symptoms. Treatment options are limited. Objective: The goal of this study is to examine the effectiveness of an online psychological intervention based on Acceptance and Commitment Therapy (ACT) in a Randomized Controlled Trial (RCT) and compared to a treatment-as-usual control condition (TAU). We aim to improve pain interference in cancer survivors with chronic painful CIPN (present for at least 3 months) in the curative disease phase who were treated with chemotherapy treatment at least 6 months ago (irrespective of disease site). Study design: It concerns a test of effectiveness of the ACT intervention in an RCT on quality of life. In total, 146 participants will be randomly allocated to one of two groups: the online ACT intervention with therapist email guidance or a control condition that receives treatment-as-usual. Patients in the control condition can follow the online ACT intervention directly after the 3 month-follow up measurement. Self-reported questionnaires will be conducted at baseline, after the intervention, and at 3- and 6-month follow-up. Additionally, interviews will be executed with a subgroup of interested patients afterwards, to explore intervention effects more in-depth. Participants will be sampled via various patient organizations, oncologists, and advertisements distributed via the PROFILES-registry that contains ongoing research projects on CIPN. Data will be collected online via the PROFILES-registry. Study population: The population consists of adult cancer survivors in the curative disease phase suffering from painful CIPN for at least 3 months and who received chemotherapy treatment 6 or more months ago. Intervention: An online ACT intervention was developed in the first phase of the QLIPP-CIPN study. In this study phase insights into daily limitations and quality of life of the patient population were gained, which served as the basis of the patient-centered development of the online ACT intervention following the CeHRes roadmap for participatory eHealth design. The intervention includes an 8-week self-management course containing 6 modules regarding psycho-education and ACT- processes. By means of text and exercises people learn to carry out value-oriented goals in daily life with pain. To do this, they learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Additionally, participants will receive email guidance. Main study parameters/endpoint: Pain interference in daily life using subscale Interference of the Multidimensional Pain Inventory (MPI). This scale focuses on a psychosocial aspect of chronic pain, specifically the interference with functioning in, for example, work, homework chores, recreational and social activities due to pain. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation is not expected to have any risks. Participants can quit the study at any moment and will not be excluded based on medication use or other current treatment for CIPN. If participants regress during the intervention and need new chemotherapy treatment, they can choose if they will continue or not. Participants do need to invest time to follow the intervention, which takes around 2 hours per week. Furthermore, it might be confronting to work on pain acceptance for participants. Benefits of participation are foremost a possible improvement in pain interference and reductions in pain and CIPN symptoms.

To be eligible for the trial, subjects must have ongoing moderate to severe neuropathic pain related to a prior course of platinum and/or taxane chemotherapy and have no clinical evidence of actively progressive disease. The trial period will comprise a Screening Period (up to 35 Days), a two-week period for the determinations of Baseline pain followed by randomization and 4-day treatment, followed by a 12-week follow up period (12 weeks total after initial treatment), and an End-of-Trial/Follow-up visit, which will occur at Week 13. This is a study to research the effects of the study drug on neuropathic pain compared placebo.

Peripheral neuropathy is a frequent condition, commonly associated with pain. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation™ (INF) (a physical therapy technique being evaluated that may help improve circulation) versus INF only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).

The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy

This phase Ib/II trial studies the side effects and best dose of nilotinib in preventing paclitaxel-induced peripheral neuropathy in stage I-III breast cancer patients who are receiving paclitaxel therapy. Chemotherapy is the usual or ?standard? treatment for breast cancer. It kills cancer cells and lowers the chance that the cancer will come back. Sometimes, this treatment can cause numbness and tingling, especially in the hands and feet. This is called chemotherapy-induced peripheral neuropathy. This study aims to test the safety and effectiveness, both good and bad, of taking nilotinib in preventing chemotherapy-induced peripheral neuropathy.

Based on network pharmacology, Liuweiluobi Granule was screened to treat diabetes peripheral neuropathy with deficiency of the spleen and kidney and stasis-heat syndrome.In the preliminary animal experiment, it suggested that this granule had a significant protective effect on the peripheral motor nerves of diabetic peripheral neuropathy and the effect of anti-inflammation, and the prescription did not induce the death of zebrafish at a concentration of 1000 ug/mL, without any obvious toxicity. This study aims to evaluate the efficacy of Liuweiluobi Granule in improving neurotransmission function in patients with diabetic peripheral neuropathy through a pilot, randomized controlled study.

Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of taxanes and platinum derivative based chemotherapeutic agents, common in breast cancer treatment regimens. It can have a significant effect on both quality of life and treatment outcomes, often resulting in dose modifications and early treatment discontinuation. The use of IncobotulinumtoxinA (INA) ((Xeomin®, Merz) has recently been shown to be effective in the treatment of neuropathic pain via inhibiting the release of several neurotransmitters involved in pain signaling pathway. The purpose of this study is to examine the efficacy and safety of intradermal INA injections for treatment of CIPN in breast cancer patients. The study will recruit a total of 40 participants, randomly assigned to receive either INA (Experimental group, n=20) or saline placebo injections (Control group n=20). Potential participants who have received chemotherapy for breast cancer will be screened for the diagnosis of peripheral neuropathy. After obtaining informed consent, participants will be further screened with the DN4 questionnaire, a clinician administered questionnaire that has a high level of sensitivity and specificity in discriminating neuropathic pain. Those study participants who score ≥4 on this tool will undergo nerve conduction studies to confirm the presence of peripheral neuropathy. Recruited study participants will then be randomized to treatment or control groups; the treatment group will undergo intradermal injections of INA (100 Units INA, total volume 5ml), and the control groups will undergo placebo injection with preservative-free normal saline (equal volume, 5mL). Total injection volume will be divided evenly and injected intradermally into a total of 50 sites on either the feet or hands (25 sites per limb). The primary outcome will be the assessment of pain using the neuropathic pain scale (NPS) prior to intervention and at eight weeks post intervention. Secondary outcomes will include the change in NPS for each domain at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months, the change in the Neuropathic Pain Impact on Quality of Life (NePIQoL) score at time points: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and the incidence of treatment related adverse events within each cohort. Statistical analysis will be utilized to determine whether the injection of intradermal INA is effective in improving pain as measured by the NPS scales vs placebo. We hypothesize that the study participants treated with INA will have lower NPS scores as compared to placebo.

This is a controlled clinical trial with the aim to study the effects of electroacupuncture on neuropathic pain reduction, quality of life and changes in sensory and motor nerve conduction velocity in patients with type 2 diabetes mellitus, beneficiaries of the familiar medical centers 20, 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City, in colaboration with the human acupuncture specialty of the Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico.