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

NCT ID: NCT00418301

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-04-30

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.

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.

Conditions

Pain; Low Back Pain; Leg Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precision Spinal Cord Stimulation and PET Scan

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

Group Type: EXPERIMENTAL

Precision Spinal Cord Stimulation and PET Scan

Intervention Type: OTHER

Imaging procedure to assess spinal Cord Stimulation.

Interventions

Precision Spinal Cord Stimulation and PET Scan

Imaging procedure to assess spinal Cord Stimulation.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Rauck, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Research

Locations

Center for Clinical Research

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

SCS0305

Identifier Type: -

Identifier Source: org_study_id