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Muscular Atrophy, Spinal clinical trials

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NCT ID: NCT05110885 Not yet recruiting - Clinical trials for Duchenne Muscular Dystrophy

Public AttitudesTowards SMA and DMD Awareness, Newborn and Carrier Screening and Physiotherapy Practices

Start date: November 2021
Phase:
Study type: Observational

The addition of SMA and DMD muscle diseases to newborn screening and premarital carrier screening has been controversial. In this study, researchers aim to measure the awareness level of SMA and DMD muscle diseases of individuals living in Turkey and to obtain information about their attitudes towards newborn and carrier screening and physiotherapy practices. Thus, this study aimed to determine the factors that affect people's views on this subject.

NCT ID: NCT05109637 Completed - Clinical trials for Spinal Muscular Atrophy

A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders

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

The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments. The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs [self-administered at home and in-clinic] between person with spinal muscular atrophy (PwSMA) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA and to evaluate the clinical safety of Konectom in PwSMA.

NCT ID: NCT05089656 Active, not recruiting - Clinical trials for Type 2 Spinal Muscular Atrophy

Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)

STEER
Start date: February 1, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy, safety and tolerability of intrathecal (IT) OAV101 in treatment naive patients with Type 2 spinal muscular atrophy (SMA) who are ≥ 2 to < 18 years of age over a 15 month trial duration.

NCT ID: NCT05073133 Completed - Clinical trials for Muscular Atrophy, Spinal

Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA) (OFELIA)

OFELIA
Start date: November 4, 2021
Phase: Phase 4
Study type: Interventional

This was a phase IV Open-label, single-arm, single-dose, multicenter study, to evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene ≤ 24 months and weighing ≤ 17 kg, over a 18-month period post infusion.

NCT ID: NCT05067790 Recruiting - Clinical trials for Spinal Muscular Atrophy

A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Previously Treated With Risdiplam

ASCEND
Start date: January 21, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate motor function following treatment with HD nusinersen in participants with spinal muscular atrophy (SMA) previously treated with risdiplam. The secondary objective of this study is to evaluate the safety and tolerability of HD nusinersen in participants with SMA previously treated with risdiplam.

NCT ID: NCT05042921 Recruiting - Clinical trials for Muscular Atrophy, Spinal

Pediatric Spinal Muscular Atrophy (SMA) China Registry

Start date: November 18, 2021
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q (5q-SMA).

NCT ID: NCT05041114 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

NCT ID: NCT05035823 Active, not recruiting - Clinical trials for Spinal Cord Injuries

COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Start date: April 27, 2022
Phase: N/A
Study type: Interventional

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

NCT ID: NCT04907162 Completed - Healthy Clinical Trials

Musculoskeletal Nociceptive Pain in Participants With Neuromuscular Disorders

Start date: April 15, 2021
Phase:
Study type: Observational

The primary aim is to characterize the prevalence, severity and quality of musculoskeletal nociceptive pain in adult patients with neuromuscular disorders (NMD). The secondary objectives are to evaluate whether severity and distribution of muscle pain is associated with muscle function, and to assess whether muscle pain is associated with alterations of muscle elasticity and muscle stiffness. Results of patients with neuromuscular disorders will be compared to age- and gender-matched healthy volunteers. Approx. 70 patients with neuromuscular disorders and 20 healthy volunteers will be enrolled, including patients with the following neuromuscular disorders: histologically confirmed inclusion body myositis (IBM), genetically confirmed late-onset Pompe disease (LOPD), genetically confirmed spinal muscular atrophy type 3 (SMA3), genetically confirmed facio-scapulo-humeral muscle dystrophy (FSHD), genetically confirmed myotonic dystrophy type 1 or type 2 (DM1, DM2). The duration of patient recruitment will be around 12 months.

NCT ID: NCT04888702 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Holter of Movement in Patients With SMA Undergoing Treatment.

Start date: August 8, 2018
Phase: N/A
Study type: Interventional

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.