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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00418301
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Low Back Pain; Leg Pain	Other: Precision Spinal Cord Stimulation and PET Scan	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Precision Spinal Cord Stimulation and PET Scan Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.	Other: Precision Spinal Cord Stimulation and PET Scan; Imaging procedure to assess spinal Cord Stimulation.

Outcome Measures

Primary Outcome Measures

1. Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off [Within a few hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00418301
• Other Study ID Numbers: SCS0305
• First Posted: Jan 4, 2007
• Last Update Posted: Mar 31, 2022
• Last Verified: May 1, 2021

• Keywords provided by Boston Scientific Corporation: Pain; Neurostimulation
• Additional relevant MeSH terms: Low Back Pain

Study Results

Participant Flow

Arm/Group Title	Precision Spinal Cord Stimulation and PET Scan
Arm/Group Description	Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation.
Period Title: Overall Study
STARTED	15
COMPLETED	12
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Precision Spinal Cord Stimulation and PET Scan
Arm/Group Description	Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Time Frame	Within a few hours

Outcome Measure Data

Analysis Population Description

Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported.

Arm/Group Title	Precision Spinal Cord Stimulation and PET Scan
Arm/Group Description	Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation.
Measure Participants	0

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported.

Arm/Group Title	Precision Spinal Cord Stimulation and PET Scan
Arm/Group Description	Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation.
Measure Participants	0

Adverse Events

Time Frame	Adverse events were collected from enrollment through end of study.
Adverse Event Reporting Description	Efforts were made but the information is not accessible at this time. Hence adverse events not reported.
Arm/Group Title	Precision Spinal Cord Stimulation and PET Scan
Arm/Group Description	Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation.
All Cause Mortality
	Precision Spinal Cord Stimulation and PET Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Precision Spinal Cord Stimulation and PET Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Precision Spinal Cord Stimulation and PET Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.