Clinical trial NCT03763708: SCS Research Study
Official title: Spinal Cord Stimulation Research Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Limb Pain
Trunk Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.


Eligibility criteria: Inclusion Criteria:

1. 22 years of age or older
2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures, including diary completion, and visits
6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

1. Implanted with neurostimulation system for an off-label indication
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
4. Has untreated major psychiatric comorbidity
5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS) - Cohort 1
timeFrame: Up to 5 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 2
timeFrame: Up to 2 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 3
timeFrame: Up to 3 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 4
timeFrame: Up to 5 months
measure: Numeric Pain Rating Scale - Cohort 5
timeFrame: Up to 5 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 6
timeFrame: Up to 7 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 7
timeFrame: Up to 8 months
measure: Numeric Pain Rating Scale (NPRS) - Cohort 8
timeFrame: Up to 0.5 months
measure: Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Center for Pain and Supportive Care
state: Arizona
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Somerset
country: United States
facility: Drez One
state: Kentucky
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Cape Girardeau
country: United States
facility: Regional Brain and Spine
state: Missouri
city: Huntersville
country: United States
facility: Carolinas Research Institute
state: North Carolina
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
Study officials:
References: