Spinal Cord Stimulation (SCS)NCT04272411
SCS Stimulation Clamp to Assess Impact of Stimulation on Glucose Metabolism
A study testing Tonic SCS stimulation and Burst SCS Stimulation in people with Spinal Cord Stimulation (SCS) and Blood Glucose Metabolism, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
In 1967 spinal cord stimulation (SCS) for the treatment of chronic neuropathic pain was established. Today various pain syndromes like the failed back surgery syndrome (FBSS), the complex regional pain syndrome (CRPS), ischemic pain or phantom limb pain are treated with SCS. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Spinal Cord Stimulation (SCS), Blood Glucose Metabolism, Euglycemic Hyperinsulinemic Clamp
- What is being tested?
- Tonic SCS stimulation and Burst SCS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jul 2019to 1 Jun 2020
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- HbA1c < 6,0%
- state after implantation of an neuromodulation device
- Clinical routine blood parameters within the normal ranges
Who cannot join
- diabetes mellitus
- Acute diseases such as infections (e.g.) within the last four weeks
- Hb < 13 g/dl
- anamnestic heparin-induced thrombocytopenia
- any neurologic or psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Burst and Tonic Spinal Cord Stimulation (SCS) in Chronic Neuropathic Pain on Blood Glucose Levels
In 1967 spinal cord stimulation (SCS) for the treatment of chronic neuropathic pain was established. Today various pain syndromes like the failed back surgery syndrome (FBSS), the complex regional pain syndrome (CRPS), ischemic pain or phantom limb pain are treated with SCS. The development of this technique based on the so called "Gate Control Theory" which states that stimulation of the mechanosensitive Aβ fibers suppresses the transmission of pain stimuli via the pain-sensitive C fibers to the brain in the spinal cord. Conventional SCS consists of periodically emitted tonic stimuli with a frequency between 30 and 120 Hz. During implantation, the electrodes are placed in the epidural space in such a way that the paraesthesia caused by nerve stimulation covers the painful area (dermatome), thus relieving the pain. In 2010 de Ridder et al. published an article presenting the so called "Burst Stimulation" where series of high-frequency impulses are released at defined time intervals (frequency: 40 Hz with peaks of 500 Hz per volley). Compared to the tonic SCS the burst technique is more effective and in most cases no paraesthesia is reported. However, potential effects of SCS stimulation on other organ systems have only been insufficiently examined.Especially possible effects of SCS on the glucose metabolism has not been investigated so far. However, it is important to investigate a possible effect for two reasons: SCS could cause severe hypoglycemia which must be avoided. Furthermore, if SCS affects blood sugar levels, it is also of interest what mechanisms are involved and how this knowledge can be used to control elevated blood glucose levels.
The present study is a pilot. The investigators want to examine possible effects of SCS therapy on blood glucose metabolism. Therefore hyperinsulinemic euglycemic clamps with an insulin infusion of 1mU / kg body weight per minute are performed. During the clamp the investigators apply different SCS techniques in a randomly order. Insulinsensitivity is determined at different time points.
- Conditions
- Spinal Cord Stimulation (SCS), Blood Glucose Metabolism, Euglycemic Hyperinsulinemic Clamp
- Being tested
- Sham SCS stimulation, Tonic SCS stimulation, Burst SCS Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham SCS stimulationDevice
Sham SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
Tonic SCS stimulationDevice
Tonic SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
Burst SCS StimulationDevice
Burst SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
| Study group | Role | What they receive |
|---|---|---|
| Sham SCS stimulation | Sham comparator | Sham SCS stimulation via implanted neuromodulation device Receives: Device: Sham SCS stimulation |
| Tonic SCS stimulation | Active comparator | Tonic SCS stimulation via implanted neuromodulation device Receives: Device: Tonic SCS stimulation |
| Burst SCS Stimulation | Active comparator | Burst SCS stimulation via implanted neuromodulation device Receives: Device: Burst SCS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation)
Effect of tonic or burst versus sham SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.
Measured: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp
Secondary outcomes (1)
Change in peripheral insulin sensitivity (tonic versus burst stimulation)
Differential effects of tonic versus burst SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.
Measured: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start11 Jul 2019
- Primary completion11 Nov 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Stimulation (SCS)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272411
- Sponsor's protocol ID
- 202/2019BO2
- Status last verified
- May 2024
- First submitted
- 7 Feb 2020
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Burst and Tonic Spinal Cord Stimulation (SCS) in Chronic Neuropathic Pain on Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT04272411
- Acronym / sponsor ID
- 202/2019BO2
- Conditions
- Spinal Cord Stimulation (SCS), Blood Glucose Metabolism, Euglycemic Hyperinsulinemic Clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Feb 2020 (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.
In 1967 spinal cord stimulation (SCS) for the treatment of chronic neuropathic pain was established. Today various pain syndromes like the failed back surgery syndrome (FBSS), the complex regional pain syndrome (CRPS), ischemic pain or phantom limb pain are treated with SCS. The development of this technique based on the so called "Gate Control Theory" which states that stimulation of the mechanosensitive Aβ fibers suppresses the transmission of pain stimuli via the pain-sensitive C fibers to the brain in the spinal cord. Conventional SCS consists of periodically emitted tonic stimuli with a frequency between 30 and 120 Hz. During implantation, the electrodes are placed in the epidural space in such a way that the paraesthesia caused by nerve stimulation covers the painful area (dermatome), thus relieving the pain. In 2010 de Ridder et al. published an article presenting the so called "Burst Stimulation" where series of high-frequency impulses are released at defined time intervals (frequency: 40 Hz with peaks of 500 Hz per volley). Compared to the tonic SCS the burst technique is more effective and in most cases no paraesthesia is reported. However, potential effects of SCS stimulation on other organ systems have only been insufficiently examined.Especially possible effects of SCS on the glucose metabolism has not been investigated so far. However, it is important to investigate a possible effect for two reasons: SCS could cause severe hypoglycemia which must be avoided. Furthermore, if SCS affects blood sugar levels, it is also of interest what mechanisms are involved and how this knowledge can be used to control elevated blood glucose levels.
The present study is a pilot. The investigators want to examine possible effects of SCS therapy on blood glucose metabolism. Therefore hyperinsulinemic euglycemic clamps with an insulin infusion of 1mU / kg body weight per minute are performed. During the clamp the investigators apply different SCS techniques in a randomly order. Insulinsensitivity is determined at different time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham SCS stimulation | Sham comparator | Device: Sham SCS stimulationSham SCS stimulation via implanted neuromodulation device |
| Tonic SCS stimulation | Active comparator | Device: Tonic SCS stimulationTonic SCS stimulation via implanted neuromodulation device |
| Burst SCS Stimulation | Active comparator | Device: Burst SCS StimulationBurst SCS stimulation via implanted neuromodulation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- HbA1c < 6,0%
- state after implantation of an neuromodulation device
- Clinical routine blood parameters within the normal ranges
Key exclusion criteria (5 listed)
- diabetes mellitus
- Acute diseases such as infections (e.g.) within the last four weeks
- Hb < 13 g/dl
- anamnestic heparin-induced thrombocytopenia
- any neurologic or psychiatric disease
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 |
|---|---|---|
| Sham SCS stimulationSham SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp. | Device | Sham SCS stimulation |
| Tonic SCS stimulationTonic SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp. | Device | Tonic SCS stimulation |
| Burst SCS StimulationBurst SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp. | Device | Burst SCS Stimulation |
Primary outcome
Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation)
Time frame: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp
Effect of tonic or burst versus sham SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.
1 secondary outcome
Change in peripheral insulin sensitivity (tonic versus burst stimulation)
Time frame: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp
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 14 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonic SCS stimulation and Burst SCS Stimulation in people with Spinal Cord Stimulation (SCS) and Blood Glucose Metabolism, run by University Hospital Tuebingen at 1 site in Germany.
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 4 inclusion and 5 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 14 May 2024. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation) (time frame: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp). 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 14 May 2024.