NCT00418301

Brief Summary

The primary objective of this study is to identify the brain regions in which activity is affected by SCS. Baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device operating at parameters which produce optimal coverage of the painful areas. The relationship between cerebral blood flow and pain rating scores will be evaluated in both conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12.2 years until next milestone

Results Posted

Study results publicly available

June 18, 2021

Completed
Last Updated

March 31, 2022

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

January 2, 2007

Results QC Date

March 31, 2021

Last Update Submit

March 29, 2022

Conditions

PainLow Back PainLeg Pain

Keywords

PainNeurostimulation

Outcome Measures

Primary Outcomes (1)

  • Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off

    Within a few hours

Secondary Outcomes (1)

  • Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off

    Within a few hours

Study Arms (1)

Precision Spinal Cord Stimulation and PET Scan

EXPERIMENTAL

Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.

Other: Precision Spinal Cord Stimulation and PET Scan

Interventions

Precision Spinal Cord Stimulation and PET ScanOTHER

Imaging procedure to assess spinal Cord Stimulation.

Precision Spinal Cord Stimulation and PET Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have had one or more back surgery procedures.
  • Have used an active Precision SCS device for chronic low back and bilateral leg pain for at least 6 weeks.
  • Have bilateral leg pain.
  • Have a baseline VAS of \>4 (without stimulation).
  • Have greater than 50% reduction in pain with SCS at optimal settings
  • Be 18 years of age or older.
  • Have the cognitive and functional capability to operate the controls for the device, to comply with directions during the study, and willing to participate in all study activities.
  • Be capable of reading and understanding patient information materials and giving written informed consent.

You may not qualify if:

  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
  • Have undergone a surgical lead revision or had any Precision components replaced after initial implantation.
  • Are allergic to any of the injected media.
  • Are pregnant or lactating.
  • Have any contraindication to the PET scan procedure itself or exposure to the intravenous radioactive tracer (H215O).
  • Have participated in any drug or device trial in the last 4 weeks or are currently participating in another drug or device trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

PainLow Back Pain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Director, Clinical Research Sciences
Organization
Boston Scientific
roshini.jain@bsci.com
6619494350

Study Officials

  • Richard Rauck, MD

    Center for Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 31, 2022

Results First Posted

June 18, 2021

Record last verified: 2021-05

Locations

US(1)