Spinal Cord Stimulation, Insulin Secretion
Conditions
Brief 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.
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.
Interventions
DEVICEBurstDR stimulation
BurstDR spinal cord stimulation
DEVICETonic stimulation
Tonic spinal cord stimulation
DEVICENo stimulation
Stimulator is switched off
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* implanted BurstDR spinal cord stimulating system * body mass index 18-25 kg/m2
Exclusion criteria
* neurological and psychatric diseases * decompensated diabetes mellitus * hemoglobin \< 13 g/dl * thrombocytopenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First and second phase of insulin secretion | Insulinsecretion during clamp (2 hours) | Modulation of insulin secretion by spinal cord stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Root Mean Square of Successive Differences (RMSSD) | Heart rate variablity during stimulation (10 minutes) | Modulation of heart rate variability by spinal cord stimulation assessed by electrocardiography |
Countries
Germany
Outcome results
None listed