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Motor Neuron Disease clinical trials

View clinical trials related to Motor Neuron Disease.

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NCT ID: NCT06119087 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study

MI-PALS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn. Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF). Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily. Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.

NCT ID: NCT06100276 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)

Start date: May 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is the study of AMT-162 in Participants with SOD1-ALS and is designed to evaluate the safety, tolerability, and exploratory efficacy of intrathecally administered gene therapy AMT-162. AMT-162-001 is a Phase 1/2, multi-center, single ascending dose study.

NCT ID: NCT06090448 Not yet recruiting - Clinical trials for Motor Neuron Disease

Technical Evaluation of Earswitch Phase B

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

The Earswitch is a demonstrated proof-of-concept that detects the voluntary contraction of a small muscle in the ear, called the tensor tympani (TT) muscle, which can be effectively used as an input switch. The voluntary activation of the TT makes the eardrum move, and such movement can be detected using a small camera inserted into the ear canal. A previously funded NIHR 'i4i Connect' research project showed how the Earswitch may be advantageous to populations with severe neuro-disabilities, where other communication methods are limited. This project aims to realise the EarSwitch's potential as an assistive communication device and provide supporting evidence towards regulatory approval of the medical device. The robustness and usability of the device will be tested on participants with mild-to-moderate neuro-disabilities and healthy participants. This complements data collected from assistive technology users following the same protocol but will provide additional data to train and understand the underlying detection algorithms for the Earswitch. The ease of which an assistive technology device can be installed and calibrated independently (without guidance from the researcher) so that it is ready to use is also an important consideration for its potential adoption. Participants will have the opportunity to interactively use the Earswitch daily at home, over a prolonged period of 4 weeks. Interviews and questionnaires will be used to gather information on usability and comfort of the device, whilst data from the interactive tasks will provide feedback of engagement and performance. Overall, this will provide crucial insights into how viable the Earswitch is as an assistive technology device and how accurately and reliably the current detection algorithm can detect contraction of the TT muscle. This data will be analysed to inform the final design of the Earswitch ready for commercial production.

NCT ID: NCT05995782 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418

Start date: December 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.

NCT ID: NCT05892822 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Registry

Start date: June 15, 2023
Phase:
Study type: Observational [Patient Registry]

This study takes amyotrophic lateral sclerosis (ALS) patients as the main research object. Through collecting genetics, imaging and clinical symptoms for Exploratory research, we will construct the gene spectrum of ALS in China, explore unknown pathogenic genes, explore the characteristic image characteristics of ALS, and establish the iPSCs library of ALS, providing resources and basis for the research of pathogenesis and treatment targets of ALS.

NCT ID: NCT05880563 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)

18F-RoSMALS
Start date: August 2023
Phase: Phase 1
Study type: Interventional

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance [18F]-RoSMA-18-d6 are being carried out for the first time. This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals. The following questions will be answered by this clinical trial. 1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ? 2. Does the amount of this protein change during the course of the disease? 3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?

NCT ID: NCT05860244 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients

WALKALS
Start date: September 2024
Phase: Phase 2
Study type: Interventional

Preclinical and clinical data strongly suggest that administration of salbutamol in ALS patients may improve walking capacity related to motor fatigue by enhancing neuromuscular transmission. Salbutamol may exert a neuroprotective effect and slow down the progression of clinical signs and symptoms. The main objective of the study is to test the efficacy of salbutamol on walking capacity in ALS patients and the secondary objective is to measure the target engagement of salbutamol on the neuromuscular junction (NMJ) at EMG (decrement of repetitive nerve stimulation in three nerves/muscle couples), as well as safety and tolerability. The exploratory objectives are to study the effect of salbutamol on fatigue scales, muscle strength, respiratory function, motor unit count, muscle and spinal MRI parameters and blood biomarkers

NCT ID: NCT05784727 Not yet recruiting - Clinical trials for Motor Neuron Disease

Technical Evaluation of Earswitch Phase A

Earswitch
Start date: June 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the Earswitch device in both participants with and without assistive technology (AT) needs. The main aim is to determine how robust the Earswitch is in detecting voluntary eardrum movements (known as ear rumbling) and see how well the Earswitch fits with other assistive technology. To do this, participants will be asked to wear the Earswitch device and voluntarily contract their TT to complete a series of tasks shown on screen and/or explained audibly. Participants will be asked to complete questionnaires to understand their opinions about the effectiveness, usability, and comfort of both their current device (if applicable) and the Earswitch. This feedback will be invaluable in developing the Earswitch.

NCT ID: NCT05621213 Not yet recruiting - ALS Clinical Trials

Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation

VNI_SLA
Start date: November 30, 2022
Phase: N/A
Study type: Interventional

Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation

NCT ID: NCT05470478 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

iBCI Optimization for Veterans With Paralysis

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.