Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
NCT ID: NCT06596200
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
10 participants
INTERVENTIONAL
2024-09-15
2026-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Group - SCS
Patients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant.
Spinal Cord Stimulation Implant
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
Interventions
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Spinal Cord Stimulation Implant
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
Eligibility Criteria
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Inclusion Criteria
* Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
* Pain severity greater than 4 out of 10 on a numeric rating scale of pain
* Pain chronicity greater than 6 months after the cessation of chemotherapy
* Failure of medical therapy, which must have included duloxetine
* Age 18 or greater
Exclusion Criteria
* Spinal anatomy precluding placement of the SCS leads between T6 and T11
* Active infection
* Estimated Lifespan less than 1 year
* Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
18 Years
ALL
No
Sponsors
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University of Maryland St. Joseph Medical Center
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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00110894
Identifier Type: -
Identifier Source: org_study_id
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