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Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00418301
First received: January 2, 2007
Last updated: July 21, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Low Back Pain
Leg Pain
 Other: Precision Spinal Cord Stimulation and PET Scan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Changes in Regional Cerebral Blood Flow as an Indicator of Neuronal Activity in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Cumulative frequency of adverse events and events per subject [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Cerebral blood flow and VAS with optimal paresthesia coverage compared with SCS off [ Time Frame: Within a few hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral blood flow and VAS with partial paresthesia coverage and subthreshold stimulation compared with optimal coverage and with SCS off [ Time Frame: Within a few hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Precision Spinal Cord Stimulation and PET Scan
    Imaging procedure to assess spinal Cord Stimulation.
Detailed Description:

Spinal Cord Stimulation (SCS) is known to be effective in pain management. Some evidence exists that SCS may cause changes in cerebral blood flow. This study will be a novel PET examination of activity in brain regions affected by SCS. This activity will be compared with the pain intensity and distribution. Further, by examining cerebral blood flow at different doses of stimulation, relationships between SCS, brain perfusion, and pain relief can be drawn. This study will contribute to the elucidation of the mechanism of action of SCS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418301

Locations
United States, North Carolina
Center for Clinical Research
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Richard Rauck, MD Center for Clinical Research
  More Information

No publications provided

Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00418301     History of Changes
Other Study ID Numbers: SCS0305
Study First Received: January 2, 2007
Last Updated: July 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Pain
Neurostimulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013