Chronic PainNAANCT06775535
Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
An observational study of Chronic Pain and Neuropathic Pain, run by Karel Hanssens at 1 site in Belgium.
Trial summary
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Neuropathic Pain, Persistent Spinal Pain Syndrome Type 2
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Aug 2023to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.
Who may be able to join
- Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
- Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
- Subject is ≥ 18 years old.
- Subject is not pregnant or nursing.
- Subject is willing and capable of giving informed consent.
Who cannot join
- Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
- Subject is incapable of understanding or responding to the study questionnaires.
- Subject is incapable of understanding or operating the patient programmer handset.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Delta
Roeselare, 8800
AZ Delta Hanssens, 0032 51 23 69 12, ctc.pijn@azdelta.be
Karel Hanssens
About this study
Official title: Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Read the detailed description
The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\' sensation.
- Being tested
- ECAP-controlled, closed-loop SCS
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECAP-controlled, closed-loop SCSDevice
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with change in stimulation sensation
Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.
Measured: 6-months
Secondary outcomes (3)
NRS
The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: Baseline, 3-months, 6-months, 12-months post-implant
Number of participants with reduced pain distribution
Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain.
Measured: Baseline, 3-months, 6-months and 12-months post-implant
Paraesthesia mapping
Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia.
Measured: 3-months, 6-months and 12-months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start2 Aug 2023
- Primary completionAug 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karel Hanssens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karel Hanssens, AZ Delta
- Investigators
- Karel Hanssens, Principal investigator, AZ Delta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775535
- Sponsor's protocol ID
- 51773
- Other IDs
- CME AZ Delta, Belgium registration number
- Acronym
- NAA
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy
- ClinicalTrials.gov ID
- NCT06775535
- Acronym / sponsor ID
- NAA / 51773
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Karel HanssensUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Jan 2025 (actual)
- 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.
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Detailed description
The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\' sensation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.
Key inclusion criteria (5 listed)
- Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
- Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
- Subject is ≥ 18 years old.
- Subject is not pregnant or nursing.
- Subject is willing and capable of giving informed consent.
Key exclusion criteria (3 listed)
- Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
- Subject is incapable of understanding or responding to the study questionnaires.
- Subject is incapable of understanding or operating the patient programmer handset.
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 |
|---|---|---|
| ECAP-controlled, closed-loop SCSSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | Device | – |
Primary outcome
Number of participants with change in stimulation sensation
Time frame: 6-months
Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.
3 secondary outcomes
NRS
Time frame: Baseline, 3-months, 6-months, 12-months post-implant
Number of participants with reduced pain distribution
Time frame: Baseline, 3-months, 6-months and 12-months post-implant
Paraesthesia mapping
Time frame: 3-months, 6-months and 12-months post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Karel Hanssens principal investigator
AZ Delta
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 Chronic Pain and Neuropathic Pain, run by Karel Hanssens 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karel Hanssens, Dr. (0032 51 23 69 12, ctc.pijn@azdelta.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with change in stimulation sensation (time frame: 6-months). 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 15 Jan 2025.