PainNCT00418301
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
A study testing Precision Spinal Cord Stimulation and PET Scan in people with Pain and Low Back Pain, run by Boston Scientific Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Low Back Pain, Leg Pain
- What is being tested?
- Precision Spinal Cord Stimulation and PET Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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
- Being tested
- Precision Spinal Cord Stimulation and PET Scan
- Keywords
- Pain, Neurostimulation
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Spinal Cord Stimulation and PET ScanOther
Imaging procedure to assess spinal Cord Stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Precision Spinal Cord Stimulation and PET Scan | Experimental | Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. Receives: Other: Precision Spinal Cord Stimulation and PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Measured: 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
Measured: Within a few hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Rauck, MD, Principal investigator, Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418301
- Sponsor's protocol ID
- SCS0305
- Status last verified
- May 2021
- First submitted
- 2 Jan 2007
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00418301
- Acronym / sponsor ID
- SCS0305
- Conditions
- Pain, Low Back Pain, Leg Pain
- Keywords
- Pain, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2007 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Spinal Cord Stimulation and PET Scan | Experimental | Other: Precision Spinal Cord Stimulation and PET ScanPositron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision Spinal Cord Stimulation and PET ScanImaging procedure to assess spinal Cord Stimulation. | Other | Precision Spinal Cord Stimulation and PET Scan |
Primary outcome
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Time frame: Within a few hours
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Rauck, MD principal investigator
Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Spinal Cord Stimulation and PET Scan in people with Pain and Low Back Pain, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off (time frame: Within a few hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.