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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:
ClinicalTrials.gov Identifier:
NCT00418301
First Posted: January 4, 2007
Last Update Posted: July 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boston Scientific Corporation
  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
Intervention Model: Single Group Assignment
Masking: None (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

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 ]
  • Cerebral blood flow and VAS with optimal paresthesia coverage compared with SCS off [ Time Frame: Within a few hours ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00418301     History of Changes
Other Study ID Numbers: SCS0305
First Submitted: January 2, 2007
First Posted: January 4, 2007
Last Update Posted: July 22, 2009
Last Verified: July 2009

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


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