RecruitingNot ApplicableNCT06421350

Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Sponsor

Scripps Health

Enrollment

32 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Complex Regional Pain Syndromes

Summary

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

years or older
neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
pre-procedure psychological clearance

Exclusion Criteria5

younger than 18 years
prior neuromodulation including spinal cord stimulation
prior dorsal root ganglion stimulation
prior peripheral nervous system stimulation
anatomical obstacles to dorsal column lead placement

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Interventions

DEVICESpinal Cord Stimulation Device

The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases.