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Cervical Spinal Cord Injury clinical trials

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NCT ID: NCT06440538 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Rebuilding Inter-limb Transfer in Cervical SCI

Start date: February 15, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills.

NCT ID: NCT06429735 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Precise Robotically IMplanted Brain-Computer InterfacE

PRIME
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.

NCT ID: NCT06288763 Recruiting - Tetraplegia Clinical Trials

Nerve Transfer to Improve Function in High Level Tetraplegia

Start date: February 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. Participants will: - undergo standard of care pre- and post-op testing and study exams - complete pre- and post-questionnaires - undergo standard of care nerve transfer surgeries - follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months - attend therapy at local therapist for up to 2 years postop.

NCT ID: NCT06101199 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

AIHH+tSCS
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine whether people with paralysis due to a spinal cord injury can benefit from breathing short intermittent bouts of air with low oxygen (O2) combined with slightly higher levels of carbon dioxide (CO2), interspaced by breathing room air. The technical name for this therapeutic air mixture is 'acute intermittent hypercapnic-hypoxia,' abbreviated as AIHH. Following exposure to the gas mixture, participants will receive non-invasive electrical stimulation to the spinal cord paired with specific and targeted exercise training. The main question this trial aims to answer is: Can the therapeutic application of AIHH, combined with non-invasive electrical stimulation to the spinal cord plus exercise training, increase the strength of muscles involved in breathing and hand function in people with paralysis due to a spinal cord injury? Participants will be asked to attend a minimum of five study visits, each separated by at least a week. During these visits, participants will be required to: - Answer basic questions about their health - Receive exposure to the therapeutic air mixture (AIHH) - Undergo non-invasive spinal electrical stimulation - Complete functional breathing and arm strength testing - Undergo a single blood draw - Provide a saliva sample Researchers will compare the results of individuals without a spinal cord injury to those of individuals with a spinal cord injury to determine if the effects are similar.

NCT ID: NCT06087445 Recruiting - Clinical trials for Cervical Spinal Cord Injury

A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.

NCT ID: NCT05786313 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

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

To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.

NCT ID: NCT05756894 Recruiting - Clinical trials for Spinal Cord Injuries

Neurostimulation for Respiratory Function After Spinal Cord Injury

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is: Changes in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals. Participants will complete a maximum of 55 study visits. They will be asked to complete about 40 treatment sessions which include multiple stimulation sessions over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed prior at baseline, after 20 sessions and after 40 sessions of study treatment.

NCT ID: NCT05665998 Recruiting - Tetraplegia Clinical Trials

Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

UP2
Start date: May 22, 2023
Phase: N/A
Study type: Interventional

Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices. In this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.

NCT ID: NCT05653206 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Incomplete Cervical SCI Without Instability

Start date: December 11, 2023
Phase:
Study type: Observational

A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.

NCT ID: NCT05638191 Recruiting - Spinal Cord Injury Clinical Trials

Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury

Start date: June 3, 2021
Phase:
Study type: Observational [Patient Registry]

The goal of this prospective, open label cohort study is to assess functional and motor outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery, with the goal of increasing upper limb function. We will also compare these outcomes to a cohort of similarly matched individuals who have not undergone nerve transfer surgery, using robust outcome measures, rigorous pre-operative clinical and neurophysiological assessments, and standardized rehabilitation. At the end of this project we aim to develop a model for predicting nerve transfer outcomes using pre-operative clinical and neurophysiological characteristics.