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Restless Legs Syndrome clinical trials

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NCT ID: NCT06233773 Not yet recruiting - Pregnancy Clinical Trials

The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome

Start date: March 2024
Phase: N/A
Study type: Interventional

Restless Leg Syndrome, a progressive and recurrent chronic sensorimotor disorder that creates an irresistible urge to move the legs and a feeling of discomfort, is seen in 15.4-26.0% of pregnant women in our country. Restless Leg Syndrome has negative effects on sleep, mood, cognitive health, daily activities and behavior in pregnant women; It can also cause preeclampsia, difficult labor, and cesarean delivery. Therefore, it is important for pregnant women with Restless Leg Syndrome to be treated appropriately. It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health. Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain. These methods are economical, reliable and easy to apply. However, no study has been found in which Kinesio taping or manual lymphatic drainage was applied to a patient group with Restless Leg Syndrome during or outside pregnancy. The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Legs Syndrome severity, sleep quality and psychological well-being in pregnant women with Restless Legs Syndrome.

NCT ID: NCT05985421 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome

RLS-BIOT
Start date: September 30, 2023
Phase:
Study type: Observational

Restless Legs Syndrome (RLS) is a common neurological sensorimotor disorder defined by an urge to move the legs when at rest that increase in the evening and at night. The pathophysiology of RLS remains poorly understood, but brain iron deficiency plays a major role. Iron absorption is an active process located in enterocytes of the proximal bowel, and is inhibited by hepcidin. The gut microbiota plays a central role in intestinal absorption, and in the maturation of the immune system. An imbalance in the microbiota, known as dysbiosis, could lead to a decrease in iron absorption, inflammation of the intestinal epithelium, and an increase in its permeability, thus favoring bacterial translocation and chronic systemic inflammation. Numerous studies showed an association between RLS and gastrointestinal diseases: Irritable bowel syndrome, Crohn's disease, ulcerative colitis, small intestinal bacterial overgrowth. However, no study has examined the gut microbiota in RLS. The investigators hypothesize that there is an imbalance of gut microbiota in patients with RLS, favoring an increased intestinal permeability and bacterial translocation, leading to chronic inflammation and reduced iron bioavailability.

NCT ID: NCT05529095 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Sublingual Apomorphine in Refractory Restless Legs Syndrome

Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

This is an open label, short placebo-controlled trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy. Investigators hypothesize that the study drug, sublingual apomorphine (Kynmobi), may improve RLS breakthrough symptoms. This study is designed to determine if sublingual apomorphine improves breakthrough symptoms in RLS patients, in addition to subjective responses.

NCT ID: NCT05350124 Not yet recruiting - Clinical trials for End Stage Renal Disease

The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis

Start date: November 2022
Phase: Phase 3
Study type: Interventional

This study aims to measure the effectiveness of vitamins C and E on relieving RLS symptoms in end stage renal disease patients on HD

NCT ID: NCT04303143 Not yet recruiting - Multiple Sclerosis Clinical Trials

Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms

HDAX1
Start date: March 2021
Phase:
Study type: Observational [Patient Registry]

Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring. Purpose is to confirm that DAX generally appears to impact SUDS value and subjects report observed level of effect on short and longer term measurements. Most significantly, testing that DAX technique/action is reusable later if the measured SUDS value returns or increases.

NCT ID: NCT03755310 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

Start date: February 2019
Phase: Phase 2
Study type: Interventional

Suvorexant improves sleep latency and wake after sleep onset in patients with primary insomnia, and is FDA approved for this condition. However, no data exist on its effects in RLS, so far. The investigators consider that suvorexant might provide a stable therapeutic efficacy for the long treatment, avoiding the risk of augmentation of symptoms commonly seen under dopamine agonists.

NCT ID: NCT02424695 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

Start date: June 2015
Phase: Phase 4
Study type: Interventional

This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG responsivity in patients with RLS. The study will include 8 visits over a period of up to 8 weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be administered within 1 to 3 weeks after Screening/Washout. The total duration of the study from the first subject enrolled to the last subject completed will be approximately 1 year.

NCT ID: NCT02264600 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Apelin in Willis Ekbom Disease

Start date: November 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.

NCT ID: NCT02256215 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Vitamin D in the Treatment of Primary Restless Legs Syndrome

Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life. The most common and potent of all treatment regimens are the dopaminergic agonist agents, which carry serious adverse events in their prolonged use despite their augmentation. A few basic studies have suggested a potential relationship between vitamin D and RLS. It has been implicated that dopaminergic system dysfunction plays a role in the development of RLS, while vitamin D has a protective effect on that system. This has been further substantiated by few clinical observations that showed prompt improvement of RLS patients upon receiving dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement therapy, as has been demonstrated in a recent pilot study. This collectively points at vitamin D as a potential, more natural and safer treatment option for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management. Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is take place over a duration of 2 years. It will be held in the city of Jeddah to assess a sample of Saudi residents of the Western region. It is comprised of a number of visits, with the first one consisting of a questionnaire that is to be answered regarding RLS, physical examination, electromyography, the objective multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit is to establish a diagnosis of RLS. Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to determine the patient's adherence to trial procedures and pharmacological treatment. Then, patients are to visit the clinic every two weeks for the first two months, then at week 12. Patients will be assessed in regards to treatment response and adverse effects through history and physical examination along with further blood tests. Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.

NCT ID: NCT01937169 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Targeting Dopamine Therapy in RLS

Start date: January 2014
Phase: N/A
Study type: Interventional

Neurons in the brain require blood and oxygen for proper function. The term "neurovascular coupling" has been postulated in the 19th century by Roy & Sherrington referring to increased blood flow to active neurons. The rationale of this research relies on the neurovascular coupling, suggesting that increased blood flow to active regions on the brain should supply not only more blood, but also more of a pharmacological agent present in the blood system at the time. Thus, active regions should be affected by the agent (=drug) to a greater extent. In the present study we focus on the dopaminergic system, critical in many functions such as cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in the brain is the nigrostriatal pathway, mediating motor function. In this research, we intend to examine the effects of coupling functional activation in this pathway with a dopaminergic agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is characterized by an irresistible urge to move the limbs (i.e. Akathisia), and results most prominently by a significant decrease in the quality of sleep. Our research focuses on this symptom of RLS to examine the effect of coupling brain activation and drug treatment. The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine levels in motor pathways, and our research will aim to couple activation in the nigrostriatal motor pathway with dopaminergic treatment in RLS. Functional activation will be achieved with a simple motor task, known to elicit activation in the nigrostriatal pathway. We hypothesize that the drug will act upon the pre-activated motor system, and that this coupling between brain activation and drug treatment will ameliorate sleep-related symptoms of RLS, compared with treating these symptoms solely with a dopaminergic drug and compared with using a non-motor task.