Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.SCEPTISMNCT01208805
Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing
An observational study of Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain., run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.
- What is being tested?
- Recording spinal cord evoked potentials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Jul 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epidural elektrodes for intractable pain (spinal cord stimulation)
Who may be able to join
- Age: 18 - 70
- Candidates for spinal cord stimulation
- Epidural electrode at the the level of the cervical or thoracic spine.
Who cannot join
- Generalized sensory deficit interfering with the recording of spinal cord evoked potentials
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Leuven
Leuven, Brabant, 3000
An Hendriks, +32 16 34 19 98, an.hendriks@uzleuven.be
Bart Nuttin, MD PhD
About this study
Official title: Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation
The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.
The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.
- Being tested
- Recording spinal cord evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording spinal cord evoked potentialsBehavioural
Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted
| Study group | Role | What they receive |
|---|---|---|
| Candidates for dorsal column stimulation | Not described Receives: Behavioral: Recording spinal cord evoked potentials |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208805
- Sponsor's protocol ID
- S52573
- Acronym
- SCEPTISM
- Status last verified
- Sep 2010
- First submitted
- 23 Sep 2010
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation
- ClinicalTrials.gov ID
- NCT01208805
- Acronym / sponsor ID
- SCEPTISM / S52573
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 24 Sep 2010 (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 study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.
The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates for dorsal column stimulation | – | Behavioral: Recording spinal cord evoked potentials |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epidural elektrodes for intractable pain (spinal cord stimulation)
Key inclusion criteria (3 listed)
- Age: 18 - 70
- Candidates for spinal cord stimulation
- Epidural electrode at the the level of the cervical or thoracic spine.
Key exclusion criteria (1 listed)
- Generalized sensory deficit interfering with the recording of spinal cord evoked potentials
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 |
|---|---|---|
| Recording spinal cord evoked potentialsRecording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted | Behavioural | Candidates for dorsal column stimulation |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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.
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 Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain., run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Sep 2010. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Theys, MD (+32 16 344290, tom.theys@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Sep 2010.