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12 recruiting in MA
Recruiting

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Tetraplegia ยท Spinal Cord Injuries ยท Amyotrophic Lateral Sclerosis

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Boston, MA18โ€“80 yrsAll genders
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Recruiting

ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

Spinal Cord Injuries ยท Blood Pressure Disorders

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.

Cambridge, MA18โ€“75 yrsAll genders
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Recruiting

Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury

Spinal Cord Injuries

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

Cambridge, MA18โ€“75 yrsAll genders
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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Brainstem Stroke ยท ALS ยท Tetraplegia

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Boston, MA18โ€“80 yrsAll genders
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Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Spinal Cord Injury ยท Pressure Injury

Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.

Boston, MA18+ yrsAll genders
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Recruiting

Connect-One: Early Feasibility Study of Connexusยฎ Brain-Computer Interface (BCI)

Amyotrophic Lateral Sclerosis ยท Neuromuscular Disease ยท Stroke

The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.

Boston, MA22โ€“75 yrsAll genders
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Recruiting

A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

Chronic Spinal Cord Injury

The goal of this clinical trial is to learn if NVG-291 can improve function in adults with chronic cervical motor-incomplete spinal cord injury. It will also learn about the safety of NVG-291. The main questions it aims to answer are: * Does NVG-291 improve hand function and daily activities? * What side effects do participants have when taking NVG-291? Researchers will compare NVG-291 to a placebo (a look-alike substance that does not contain NVG-291) to see if NVG-291 improves function in adults with chronic cervical motor-incomplete spinal cord injury. Participants will: * Take NVG-291 or a placebo by injection under the skin (subcutaneous) once daily for 12 weeks. * Attend clinic visits for checkups and safety tests. * Complete tests and questionnaires about hand function, walking, daily activities, and quality of life. * Take part in an interview about changes in their condition, within 14 days after the Week 12 visit.

Boston, MA18โ€“75 yrsAll genders
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Recruiting

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Adjustment Disorder

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Boston, Worcester, MA18โ€“80 yrsAll genders
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Recruiting

Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

Spinal Cord Injuries

The goal of this interventional study is to understand how regular yogic breathing practice, particularly a slow resistive yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Previously yogic breathing has shown to improve respiratory function and sleep- we'd like to explore this further. The main questions this study aims to answer are: * How does Ujjayi breathing affect breathing patterns in individuals with spinal cord injuries? * How does Ujjayi breathing affect lung function in individuals with spinal cord injuries? * How does Ujjayi breathing affect the part of the nervous system responsible for ventilatory control in individuals with spinal cord injuries? * How does Ujjayi breathing affect ventilatory perfusion (how well air and blood flow match in the lungs for efficient gas exchange) in individuals with spinal cord injuries? * How does Ujjayi breathing affect sleep quality in individuals with spinal cord injuries? Participants will undergo six weeks of training in Ujjayi breathing. Before and after this period, they will visit the lab for measurements of blood pressure, pulse, blood oxygen levels, and breathing. They will also perform several tests: * Pulmonary function testing to assess lung capacity and respiratory muscle strength. * Pace breathing frequency to four pre-recorded audio files at various breathing rates. * Breathing exercises involving higher levels of carbon dioxide for a short time. * Breathing exercises involving lower levels of oxygen for a short time. * At-home sleep evaluation. Between the two laboratory testing sessions, participants will practice yogic resistance breathing (Ujjayi breathing) for six weeks.

Cambridge, MA18โ€“60 yrsAll genders
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