Task Practice and Spinal Cord Stimulation

Launched by UNIVERSITY OF MIAMI · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how combining specific practice tasks with a non-invasive treatment called transcutaneous cervical spinal cord stimulation can help people with cervical spinal cord injuries who experience spasticity, which is muscle stiffness or spasms. The researchers want to see if using higher stimulation frequencies can reduce this stiffness and improve movement. Individuals who are between 22 and 70 years old and have had a stable spinal cord injury for at least a year may be eligible to participate.

Participants will need to be able to engage in therapies focused on their upper body and will have to meet certain health criteria, such as having a specific score on a muscle stiffness test. Throughout the trial, they can expect to receive this stimulation treatment along with guided practice sessions. It’s important for potential participants to know that they need to be stable in their overall health and must not have certain medical conditions that could interfere with the study. The trial is currently recruiting participants, and those interested should be prepared to commit time to the study activities.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 22-70 years of age
• • Non-progressive cervical spinal cord injury
• • Minimum 12 months year post-injury.
• • American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
• • Able to take part in upper extremity therapy procedures.
• • GRASSP-Prehension score ≥10.
• • MAS Score ≥3 but \<6 in at least one arm.
• • Can commit to the time required for the study.
• • Stable medication profile for at least 4 weeks prior to enrollment.
• • Able to reduce Baclofen dose to 30 mg or less daily.
• • Capable of providing informed consent.
• Exclusion Criteria:
• • Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
• • Has uncontrolled cardiopulmonary disease or cardiac symptoms.
• • Requires ventilator support.
• • Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
• • Has an autoimmune etiology of spinal cord dysfunction/injury
• • Previously diagnosed as having transverse myelitis
• • History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
• • Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• • Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
• • Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
• • Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
• • Breakdown in skin area that will come into contact with electrodes.
• • Presence of syringomyelia as determined by an MRI.
• • Currently undergoing treatment for cancer or has been in remission for less than 2 years.
• • Received stem cell treatment within the past two years prior to enrollment.
• • Has any active implanted medical device.
• • Concurrent participation in another drug or device trial that may interfere with this study.
• • In the opinion of the investigators, the study is not safe or appropriate for the participant.
• • Persons who are unable to consent, pregnant women, and prisoners.