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NCT05794776 Clinical Trial

Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans

Spinal Cord Stimulation Clinical Trial

Official title:
Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05794776
Other study ID # 047/2022BO2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 16, 2023
Est. completion date October 1, 2023

Study information
Verified date February 2023
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BurstDR stimulation
BurstDR spinal cord stimulation
• Tonic stimulation
Tonic spinal cord stimulation
• No stimulation
Stimulator is switched off

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary First and second phase of insulin secretion Modulation of insulin secretion by spinal cord stimulation Insulinsecretion during clamp (2 hours)
Secondary 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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