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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BurstDR stimulation | Experimental | BurstDR spinal cord stimulation during hyperglycemic clamp |
|
| Tonic stimulation | Experimental | Tonic spinal cord stimulation during hyperglycemic clamp |
|
| No stimulation | Placebo Comparator | No spinal cord stimulation during hyperglycemic clamp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BurstDR stimulation | Device | BurstDR spinal cord stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| First and second phase of insulin secretion | Modulation of insulin secretion by spinal cord stimulation | Insulinsecretion during clamp (2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Root Mean Square of Successive Differences (RMSSD) | Modulation of heart rate variability by spinal cord stimulation assessed by electrocardiography | Heart rate variablity during stimulation (10 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Morgalla, Prof. | Universitaetsklinikum Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
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| Tonic stimulation |
| Device |
Tonic spinal cord stimulation |
|
| No stimulation | Device | Stimulator is switched off |
|
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