Spinal Cord StimulationNCT05794776
Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans
A study testing BurstDR stimulation, Tonic stimulation and No stimulation in people with Spinal Cord Stimulation and Insulin Secretion, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Stimulation, Insulin Secretion
- What is being tested?
- BurstDR stimulation, Tonic stimulation and No stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2023to 1 Oct 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- implanted BurstDR spinal cord stimulating system
- body mass index 18-25 kg/m2
Who cannot join
- neurological and psychatric diseases
- decompensated diabetes mellitus
- hemoglobin < 13 g/dl
- thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain
This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.
Read the detailed description
This study investigates the effect of spinal cord stimulation (BurstDR stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. To assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. Three different stimulation conditions (BurstDR, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. A total of 30 clamps are carried out.
- Conditions
- Spinal Cord Stimulation, Insulin Secretion
- Being tested
- BurstDR stimulation, Tonic stimulation, No stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurstDR stimulationDevice
BurstDR spinal cord stimulation
Tonic stimulationDevice
Tonic spinal cord stimulation
No stimulationDevice
Also called No spinal cord stimulation
Stimulator is switched off
| Study group | Role | What they receive |
|---|---|---|
| BurstDR stimulation | Experimental | BurstDR spinal cord stimulation during hyperglycemic clamp Receives: Device: BurstDR stimulation |
| Tonic stimulation | Experimental | Tonic spinal cord stimulation during hyperglycemic clamp Receives: Device: Tonic stimulation |
| No stimulation | Placebo comparator | No spinal cord stimulation during hyperglycemic clamp Receives: Device: No stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First and second phase of insulin secretion
Modulation of insulin secretion by spinal cord stimulation
Measured: Insulinsecretion during clamp (2 hours)
Secondary outcomes (1)
Root Mean Square of Successive Differences (RMSSD)
Modulation of heart rate variability by spinal cord stimulation assessed by electrocardiography
Measured: Heart rate variablity during stimulation (10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start16 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023 (estimated)
Why it stopped: No participants enrolled anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord StimulationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Morgalla, Prof., Principal investigator, Universitaetsklinikum Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794776
- Sponsor's protocol ID
- 047/2022BO2
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 10 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05794776
- Acronym / sponsor ID
- 047/2022BO2
- Conditions
- Spinal Cord Stimulation, Insulin Secretion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 3 Apr 2023 (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.
This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.
Detailed description
This study investigates the effect of spinal cord stimulation (BurstDR stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. To assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. Three different stimulation conditions (BurstDR, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. A total of 30 clamps are carried out.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BurstDR stimulation | Experimental | Device: BurstDR stimulationBurstDR spinal cord stimulation during hyperglycemic clamp |
| Tonic stimulation | Experimental | Device: Tonic stimulationTonic spinal cord stimulation during hyperglycemic clamp |
| No stimulation | Placebo comparator | Device: No stimulationNo spinal cord stimulation during hyperglycemic clamp |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- implanted BurstDR spinal cord stimulating system
- body mass index 18-25 kg/m2
Key exclusion criteria (4 listed)
- neurological and psychatric diseases
- decompensated diabetes mellitus
- hemoglobin < 13 g/dl
- thrombocytopenia
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 |
|---|---|---|
| BurstDR stimulationBurstDR spinal cord stimulation | Device | BurstDR stimulation |
| Tonic stimulationTonic spinal cord stimulation | Device | Tonic stimulation |
| No stimulationAlso: No spinal cord stimulationStimulator is switched off | Device | No stimulation |
Primary outcome
First and second phase of insulin secretion
Time frame: Insulinsecretion during clamp (2 hours)
Modulation of insulin secretion by spinal cord stimulation
1 secondary outcome
Root Mean Square of Successive Differences (RMSSD)
Time frame: Heart rate variablity during stimulation (10 minutes)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Matthias Morgalla, Prof. principal investigator
Universitaetsklinikum Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BurstDR stimulation, Tonic stimulation and No stimulation in people with Spinal Cord Stimulation and Insulin Secretion, 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 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 was withdrawn before enrolling participants, so there are no results.
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?
First and second phase of insulin secretion (time frame: Insulinsecretion during clamp (2 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 10 May 2024.