Spinal Cord Stimulation for Multiple System Atrophy: a Single-center, Single-arm Open Trial
Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for multiple system atrophy with SCS. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in multiple system atrophy (MSA) patients before and after SCS treatment, and shed new light on the treatment for MSA.
NCT05171205 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05171205/
Molecular Imaging of Synaptic Loss in Multiple System Atrophy (MSA)
In this study the investigators would like to investigate the degree of damage of the synapses, an important part of the neurons vital for the communications between neurons, in Multiple System Atrophy (MSA).
NCT05121012 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05121012/
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy
NCT05109091 — Multiple System Atrophy
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05109091/
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of Lu AF82422 in Patients With Multiple System Atrophy
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
NCT05104476 — Multiple System Atrophy
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT05104476/
Intermediate-Size Patient Population Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)
The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.
NCT05086094 — Multiple System Atrophy (MSA)
Status: No longer available
http://inclinicaltrials.com/multiple-system-atrophy-msa/NCT05086094/
Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.
NCT04965922 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT04965922/
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
The prevalence of Multiple System Atrophy (MSA) is reported to be between 3.4 - 4.9 cases per 100,000 population. The estimated average incidence is 0.6 - 0.7 cases per 100,000 people per year. Many patients are not diagnosed properly during their lifetime because of the difficulty in differentiating MSA from other disorders. Approximately 29 - 33% of patients with isolated late onset cerebellar ataxia and 8 - 10% of patients with parkinsonism will develop MSA. There are currently no therapies that can cure or stop the progression of the disease. The current pharmacological therapy is only to relieve symptoms. Mesenchymal stem cells (MSC) are considered an efficient source of cells for therapy, because they can be safely harvested and transplanted to donors or patients, have low immunogenicity, and have broad therapeutic potential. Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration. Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue, in addition after transplantation, MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents. The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA. There will be three treatment groups with a total sample of 5 subjects each. Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally. Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally. Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously. Clinical improvement will be evaluated using the UMSARS scale, PET-Scans, MRI, DaTScan, IGF-1, BDNF, Sympathetic skin respons (SSR), EMG, Composite Autonomic Severity Score (CASS), High definition-Optical coherence tomography (HD-OCT), ERG, VEP, Log MAR chart, Ishihara test and side adverse effect on MSC. This study is divided into six timeframes : Before an implantation, First Month after second implantation, Third month after secondary implantation, Sixth month after second implantation, Ninth month after second implantation and Twelve month after second implantation. The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects.
NCT04876326 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT04876326/
Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.
NCT04782284 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT04782284/
Randomized, Double-Blind, Placebo-controlled Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2-GDNF) in Multiple System Atrophy
The objective of this randomized, double-blinded, placebo-controlled Phase 1 investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a possible or probable diagnosis of Multiple System Atrophy.
NCT04680065 — Multiple System Atrophy
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy/NCT04680065/
Deep Brain Stimulation and Spinal Cord Stimulation Therapy Improve Motor Function in Multiple System Atrophy With Predominant Parkinsonism: a Multi-center, Prospective, Open Label Clinical Trial
Multiple system atrophy (MSA) is a debilitating and fatal neurodegenerative disorder and symptomatic therapeutic strategies are still limited.The parkinsonian type of MSA (MSA-P) has parkinsonian symptoms as its prominent manifestation, although Deep brain stimulation (DBS) at the subthalamic nucleus or globus pallidus interna has been an established treatment for Parkinson's disease patients, it is mostly ineffective in MSA-P patients, the improvement in motor function as short-lasting and rapidly followed by the early appearance of freezing of gait (FOG) and postural instability that counteracted DBS benefits and often leads to significant disability and loss of quality of life. Recently, some pilot studies demonstrated the safety and significant therapeutic outcome of SCS for FOG.The purpose of this clinical study is to understand the effectiveness of DBS combined with SCS for symptomatic treatment of MSA-P.
NCT04617873 — Multiple System Atrophy, Parkinson Variant (Disorder)
Status: Recruiting
http://inclinicaltrials.com/multiple-system-atrophy-parkinson-variant-disorder/NCT04617873/