Complex Regional Pain Syndrome (CRPS)NCT01512121
Spinal Cord Stimulation and Functional MRI
An observational study of Complex Regional Pain Syndrome (CRPS) and Neuropathic Leg Pain, run by Vibhor Krishna at 1 site in United States.
Trial summary
The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Complex Regional Pain Syndrome (CRPS), Neuropathic Leg Pain
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with implanted spinal cord stimulators
Who may be able to join
- Age 18-55 years at time of enrollment.
- Have previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.
- Patient must have reported significant pain improvement (>50%) following implantation of the SCS.
- Have consistently reproducible pain relief (> 50%) within 10 minutes of switching SCS from an OFF state to an ON state (with "optimal" parameters - see below).
- The SCS battery is implanted in the buttocks region.
- Unilateral or bilateral extremity pain.
- Able to provide informed consent.
Who cannot join
- Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia
- Pattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with "optimal" parameters) - long "washout" period Lack of significant pain improvement (< 50%) following implantation of SCS
- Positive history of significant brain lesions or pathology including:
- Prior ablative neurosurgery
- History of large vessel strokes or brain tumors
- Psychological Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging
The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.
Read the detailed description
The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement.
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| functional MRI testing | fMRI scanning with SCS "on" and "off" at different settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis
We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome (CRPS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibhor Krishna
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Vibhor Krishna, Ohio State University
- Investigators
- Vibhor Krishna, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512121
- Sponsor's protocol ID
- 2011H0040
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2012
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01512121
- Acronym / sponsor ID
- 2011H0040
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vibhor KrishnaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2011 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.
Detailed description
The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| functional MRI testing | – | –fMRI scanning with SCS "on" and "off" at different settings. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with implanted spinal cord stimulators
Key inclusion criteria (7 listed)
- Age 18-55 years at time of enrollment.
- Have previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.
- Patient must have reported significant pain improvement (>50%) following implantation of the SCS.
- Have consistently reproducible pain relief (> 50%) within 10 minutes of switching SCS from an OFF state to an ON state (with "optimal" parameters - see below).
- The SCS battery is implanted in the buttocks region.
Key exclusion criteria (6 listed)
- Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia
- Pattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with "optimal" parameters) - long "washout" period Lack of significant pain improvement (< 50%) following implantation of SCS
- Positive history of significant brain lesions or pathology including:
- Prior ablative neurosurgery
- History of large vessel strokes or brain tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis
Time frame: 1 year
We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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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.
Vibhor Krishna, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndrome (CRPS) and Neuropathic Leg Pain, run by Vibhor Krishna 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 7 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 23 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis (time frame: 1 year). 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 23 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.