Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

NCT06421350 | Recruiting FDA Device

• 1 other identifier: 24-8347
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (2)

• Change in Complex Regional Pain Syndrome Severity Scores

  (CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.

  Baseline, 7 day trial period, 3 months, 6 months

• Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device

  Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.

  7 day trial period, 3 months, and 6 months.

Secondary Outcomes (10)

• Change in Prolactin Levels

  Baseline, 7 day trial period, and 3 months

• Visual Analogue Pain Scale

  Baseline, 7 day trial period, 3 months, and 6 months

• Quality of Life Questionnaire

  Baseline, 7 day trial period, 3 months, and 6 months

• Patient Reported Outcomes Measurement Information System-29 v 2.1

  Baseline, 7 day trial period, 3 months, and 6 months

• General Anxiety Disorder-7

  Baseline, 7 day trial period, 3 months and 6 months.

Study Arms (2)

Acute and Subacute Phases of CRPS

EXPERIMENTAL

Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group.

Device: Spinal Cord Stimulation Device

Chronic Phase of CRPS

EXPERIMENTAL

Participants diagnosed with chronic CRPS will be assigned to this group.

Device: Spinal Cord Stimulation Device

Interventions

Spinal Cord Stimulation Device 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.

Acute and Subacute Phases of CRPS; Chronic Phase of CRPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• David B Hiller, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie C McCauley

CONTACT

585-554-7122; mccauley.julie@scrippshealth.org

Roslyn M Kackman

CONTACT

858-554-7122; kackman.roslyn@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 20, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)