Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity

Launched by JOHNS HOPKINS UNIVERSITY · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Closed Loop Spinal Cord Stimulation (SCS) to help manage spasticity, which is increased muscle stiffness and spasms that can occur after a stroke or other brain injuries. Spasticity can make it difficult for people to move freely and can cause discomfort. The researchers aim to see if this new method can effectively reduce spasticity in patients suffering from chronic pain and improve their overall function.

To participate in this trial, individuals must be at least 18 years old, have had their first stroke, and have been experiencing chronic pain and spasticity in one or more limbs for more than three months. Participants will be monitored throughout the study to assess how well the spinal cord stimulation works in managing their symptoms. This trial is open to all genders, and the goal is to find a safer and more effective alternative to current treatments that often come with risks and side effects. If you or a loved one fits these criteria, this trial could offer a new hope for better managing spasticity after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. First-ever stroke
• • 2. Aged 18 and older
• • 3. Neuropathic pain \>3 months (chronic)
• • 4. Brain injury associated with spasticity in one or multiple limbs \>3 months post-stroke
• • 5. No previous history of neuropathic pain or spasticity in affected limbs
• • 6. Cognitively capable to operate the SCS system
• Exclusion Criteria:
• • 1. Inadequate Pain Severity: Patients with mild or non-debilitating pain may be excluded if the treatment is intended for individuals with moderate to severe pain.
• • 2. Previous SCS Implantation: Patients who have previously undergone SCS implantation may be excluded to focus on those who are new to the therapy.
• • 3. Inadequate Pain Duration: Some trials may exclude patients whose pain has not persisted for a minimum period to ensure that the pain condition is chronic.
• • 4. Medical Comorbidities: Patients with certain medical conditions or comorbidities that may increase the risks associated with SCS, such as uncontrolled cardiovascular disease, uncontrolled diabetes, or active infections, may be excluded.
• • 5. Psychological Factors: Patients with severe psychiatric disorders or psychological conditions that may interfere with the assessment of pain or the ability to provide informed consent may be excluded.
• • 6. Allergies or Sensitivities: Patients with allergies to materials used in SCS devices or contraindications to the anesthesia used during implantation may be excluded.
• • 7. Substance Abuse: Patients with active substance abuse or addiction issues may be excluded due to concerns about treatment compliance and efficacy.