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Phantom Limb clinical trials

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NCT ID: NCT05545358 Not yet recruiting - Phantom Pain Clinical Trials

Neural Bases of Phantom Pain After Amputation

Phantom limb
Start date: October 2022
Phase:
Study type: Observational

The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.

NCT ID: NCT05460845 Completed - Amputation Clinical Trials

The Pain in Amputees Reduced by Administration of Diet Examination

PARADE
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Phantom limb pain (PLP) is defined as pain or discomfort in a missing limb following amputation, whereas residual limb pain (RLP) is often experienced as pain at the site of amputation. Unfortunately, PLP can affect as many as 80% of upper- or lower-extremity amputees, with 40-60% also experiencing RLP. There are many theories regarding the mechanisms underlying these types of pain, but effective treatments remain elusive .Amputation of a limb is often accompanied by a traumatic event that can be emotionally devastating. Consequently, studies have reported high levels of depression in this population, up to 80%. Other studies have reported elevated levels of depression (70%), suicidality (30%) and posttraumatic stress disorder (PTSD, 20%) with PTSD being highly correlated with PLP. Thus, it is critical that effective treatments be employed that address, not only the chronic pain, but the comorbid conditions as well. Diet interventions have been utilized as a non-pharmacological method to reduce pain and/or inflammation. We have shown that a low-carbohydrate diet (LCD) reduced pain independent of weight loss. Importantly, we observed a reduction in depressive symptomology and improved quality of life (QOL) following the LCD. Thus, it is reasonable to expect that the LCD may have beneficial effects of pain experience and also on measures of QOL. Phase 1: To characterize the dietary habits, pain severity and psychological well-being of the local amputee population. Hypotheses: We expect that the local population will show high prevalence of phantom limb pain (PLP) and/or residual limb pain (RLP). Self-report of depressive symptomology, poor-quality diet, will coincide with low QOL reports. Phase 2: To assess the feasibility and efficacy of a low-carbohydrate diet (LCD) to reduce pain and increase QOL in amputees. Hypotheses: All participants will complete the 6-week LCD. Compared to baseline, a 6-week LCD will reduce self-reports of pain and depressive symptoms. Overall QOL will improve over 6 weeks with concomitant improved mood and sleep.

NCT ID: NCT05392803 Completed - Phantom Limb Pain Clinical Trials

Pulsed Electromagnetic Fields for Post-Amputation Pain

Start date: August 5, 2022
Phase: N/A
Study type: Interventional

Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 30 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating chronic post-amputation pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect in preparation for developing subsequent definitive clinical trials.

NCT ID: NCT05344261 Withdrawn - Amputation Clinical Trials

Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

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

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

NCT ID: NCT05296265 Recruiting - Phantom Limb Pain Clinical Trials

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

Start date: May 10, 2022
Phase: N/A
Study type: Interventional

After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The proposed work will contrast the efficacy of two virtual reality treatments for phantom limb pain: a 'Distractor' and an Active VR treatment. In the Distractor treatment, participants are engaged in a visually immersive virtual reality experience that does not require leg movements (REAL i-Series® immersive VR experience). In the Active VR treatment, subjects play a series of VR games using the virtual rendering of both legs.

NCT ID: NCT05247827 Completed - Amputation Clinical Trials

The Effects of Targeted Phantom Motor Execution on Phantom Limb Control

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Lower limb amputations account for more than 85% of all amputations. In Canada, it has been reported that transtibial amputation (TTA) is the most common level of amputation. Many people with limb amputation have awareness and feel that their missing limb still exists (phantom limb), with perceptions of sensation or pain, and the ability to move the limb with or without intention. Phantom limb sensation (PLS) is defined as all non-painful somatic sensations (e.g. sense of the limb position, touch, pressure, warmth or cold, or movement) in the missing part of the limb. The incidence of PLS is about 60% in adults after 17 months. In addition to PLS, 60-70% of people with amputation experience phantom limb pain (PLP), an intense chronic pain perception in their phantom limb, in the first year after amputation. Although PLP is well known to decrease the quality of life and lessen function, little is known about PLS and phantom limb control (PLC), the ability to intentionally move or control movements of the phantom limb. Enhancing PLS and PLC especially in the immediate months after amputation, could decrease painful perception, facilitate prosthetic control, and improve the function of people with amputations. Keeping this therapeutic and rehabilitative significance in mind, it is hypothesized that a targeted program of phantom motor execution, designed to address phantom limb awareness (PLA), the general knowledge of the presence or existence of the missing limb as one's own, could be associated with improving PLC in people with TTA. Furthermore, prosthetic embodiment, the sense that the prosthesis is accepted as a part of the body with the same functional abilities, may play a role in PLC. Investigating the association of PLC, as one of the phantom phenomena (i.e. PLA, PLS, PLP, and PLC), with surgical, clinical, and demographic characteristics of people with TTA will provide better insight into how phantom phenomena develop. The association of PLC with physical function has significant clinical importance that has never been investigated in people with TTA.

NCT ID: NCT05224336 Recruiting - Phantom Limb Pain Clinical Trials

Psilocybin-assisted Therapy for Phantom Limb Pain

Start date: January 1, 2022
Phase: Phase 1
Study type: Interventional

This double-blind placebo-controlled pilot study seeks to investigate whether psilocybin can be safely administered to people with chronic phantom limb pain (PLP) in a supportive setting with close follow-up, and its effects on pain symptoms and other moods, attitudes, and behaviors. The investigators' primary hypotheses are that psilocybin is safe to administer in people with PLP and that it will reduce scores on measures of pain. The investigators will also assess a number of secondary measures related to the behavioral and neural responses to pain after psilocybin treatment.

NCT ID: NCT05194800 Withdrawn - Phantom Limb Pain Clinical Trials

Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain

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

The purpose of this project is to further investigate the use of Virtual Mirror therapy for alleviating symptoms of chronic phantom limb pain. This initial pilot study will inform a fully powered randomized control trial which will include both upper and lower extremity amputees

NCT ID: NCT05188183 Recruiting - Phantom Limb Pain Clinical Trials

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response

PLP-EVEREST
Start date: September 13, 2022
Phase: N/A
Study type: Interventional

The investigators have designed a pragmatic trial of home-based transcranial direct current stimulation (tDCS) for phantom limb pain (PLP), the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the primary motor cortex (M1) with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The Investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.

NCT ID: NCT05177341 Not yet recruiting - Clinical trials for Amputation, Traumatic

Investigating The Effect of Phantom Sensation on Gait in Individuals With Unilateral Below-Knee Amputation

Start date: January 2022
Phase:
Study type: Observational

Amputation is a problem that can be encountered for many reasons, can cause functional disability in varying severities and puts a multifaceted financial burden on individuals, society, and states. The phantom feeling is the state of the sensory sensation of a limb that does not already exist and is observed in various forms in individuals with amputation. The aim of this project is to investigate whether the phantom sensation affects autocorrelation of gait in unilateral amputated individuals and thus to determine whether the phantom sensation is a functional sensation that affects the multifaceted nature of gait. In addition, the measurement of whether phantom sensation contributes to the ability of amputees to adapt to changing conditions and obtaining a unique calculation method that determines autocorrelation are other specific aspects of the study. The study will be conducted on individuals with unilateral traumatic transtibial amputation who have acceptable phantom sensation, individuals with no-phantom sensation and healthy individuals. Individuals who meet the inclusion criteria will be included in the gait assessment. During the evaluation, at least 512 consecutive steps will be collected from each individual when walking on the treadmill at their preferred speed. The walk test will then be repeated on the perturbation treadmill of 5-10%. It will be determined whether the gait characteristics obtained by gait analysis show autocorrelation by using signal processing methods.