Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT06421350
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acute and Subacute Phases of CRPS
    Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group.
  • Experimental: Chronic Phase of CRPS
    Participants diagnosed with chronic CRPS will be assigned to this group.

Primary Outcome Measure

Change in Complex Regional Pain Syndrome Severity Scores [ Time Frame: Baseline, 7 day trial period, 3 months, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Clinic Torrey PinesLa JollaCalifornia92037
Julie C McCauley
[email protected]
585-554-7122
Roslyn M Kackman
[email protected]
858-554-7122
David B Hiller, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Scripps Clinic Torrey Pines· La Jolla, CA

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