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Final Program


Final Program

1517 - CLONUS Trial: Closed Loop SCS for Neuromodulation of Upper Motor Neuron Lesion Spasticity

Friday, February 28, 2025
5:00 PM - 6:30 PM MST

    Presenting Author(s)

  • HC

    Harman Chopra, MD

    Senior Resident
    Johns Hopkins
    Baltimore, Maryland, United States

    • Co-Author(s)

  • TA

    Tariq AlFarra, DO

    Assistant Professor
    Icahn School of Medicine at Mount Sinai
    New York, New York, United States

  • MB

    Mustafa Broachwala, DO

    Fellow
    University of California San Diego
    La Jolla, California, United States

    • Corresponding Author(s)

  • AC

    Akhil Chhatre, MD

    Assistant Professor
    Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States

Objectives: Specific Aims

1: Assess the Impact of Spinal Cord Stimulation (SCS) on Neuropathic Pain in Post-UMN Lesion Individuals (Stroke)
1.1: Evaluate the reduction in neuropathic pain severity among post-UMN lesion individuals using standardized pain assessment scales such as the Numerical Rating Scale (NRS) or the Visual Analog Scale (VAS) before and after SCS treatment.
1.2: Compare changes in neuropathic pain scores between the SCS intervention group and a control group over the study period to determine the efficacy of SCS in alleviating neuropathic pain in patients with post-UMN lesion spasticity.
 
2: Assess the Effect of Spinal Cord Stimulation (SCS) on Post-UMN Lesion Spasticity
2.1: Evaluate the reduction in spasticity severity in individuals using the Modified Ashworth Score (MAS) as the primary outcome measure.
2.2: Compare the changes in MAS scores between the SCS intervention group and a control group over a designated study period.
 

Design: - 10 total patients.

- prospective pilot study

- We will perform 1-week, 1-month, 3-month, 6-month and 12-month follow-up at our continuity clinic

- Phase 1: Trial for 7 days; if >40% pain relief/improvement in spasticity or function will consider for next phase

- Phase 2: Permanent Implant

o Perform a follow-up visit with the device turned off to examine acute response to stimulation (~6 month follow-up)

Outcome Measures:
Primary

- Pain relief
Secondary:
- Reduction in spasticity severity using the Modified Ashworth Score (MAS)

- Improvement in muscle strength from baseline exam

- Improvement in VAS scores or SF-36

- Reduction in use of pain and spasticity medications (gabapentin, baclofen, tizanidine etc.)



Results: Results are pending as this trial just began July 2024. https://clinicaltrials.gov/study/NCT06384170

Conclusions: - A pilot study to explore the efficacy of SCS for treating a prevalent and often overlooked condition.- If the results are successful, we will recruit for a crossover RCT.