Clinical Research Directory

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.

Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients

Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in "gloves and socks") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders). In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM). PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.

Wearable Focused Ultrasound Stimulation for Peripheral Nerve Pain Management

This study will evaluate the feasibility of a novel wearable focused ultrasound (FUS) device for peripheral nerve stimulation in healthy volunteers. The aim is to assess device operability, usability, tolerability, and physiological responses during standardized sensory tests. Each participant will complete nine \~1-hour study sessions across multiple days, including cold pressor and algometry tasks performed under baseline, sham, and active FUS conditions.

Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.

The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are: 1. The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain 2. The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events. Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.

Protocol Assessment of Motor Cortex rTMS for Treating Neuropathic Pain

Neuropathic pain is frequent and drugs relieves only 50% of the patients. Repetitive transcranial magnetic stimulation (rTMS) at high frequency (HF, usually 10Hz) applied on the primary motor cortex (M1) is an effective treatment of neuropathic pain. For the treatment of chronic pain, the 'classical' HF-rTMS protocol (CHF-rTMS) include one daily session for one or two weeks as an induction phase of treatment followed by a weekly session to produce analgesic effects. However, another type of protocol is based on a more spaced repetition of HF-rTMS sessions (SHF-rTMS), including intervals of several days or weeks between two sessions, but also resulting in a significant pain relief. However, CHF-rTMS and SHF-rTMS have never been compared regarding their analgesic efficacy. Alongside with pain, depression is the other clinical condition for which HF-rTMS is proposed as an effective therapeutic strategy. Another type of rTMS paradigm, called "accelerated intermittent theta burst stimulation" (ACC-iTBS) protocol has been recently proposed for the treatment of depression, combining a high number of pulses delivered per session and a high number of short-duration sessions grouped into a few days of stimulation. However, this type of protocol has never been applied for the treatment of chronic pain patients. Thus, for the first time we propose to compare in a pilot study the efficacy of three different rTMS protocols for the treatment of chronic neuropathic: CHF-rTMS, SHF-rTMS, and ACC-iTBS. In this study, two protocols two rTMS protocols (CHF-rTMS and ACC-iTBS) will share the same high total number of TMS pulses (i.e. 30 000 pulses) versus an rTMS protocol (SHF-rTMS) based on a lower total number of TMS pulses (i.e. 6 400 pulses), while one protocol (CHF-rTMS) will include a higher number of days of stimulation (i.e. 10 days) compared to the two other protocols (ACC-iTBS and SHF-rTMS) (i.e. 4 days). In all cases, the motor cortical target and the intensity of stimulation will the same. Thus, this study will be able to appraise the respective influence of the number of pulses delivered (the higher the number, the greater the effect) and the number of sessions (the higher the number, the more restrictive the implementation of treatment). That is to say that the new ACC-iTBS protocol could be an optimal compromise of a more efficacious and more easy-to-perform rTMS protocol for the treatment of patients with chronic pain.

Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort

Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.

Vitamin D Supplementation in Breast Cancer Patients

It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.