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

Not Applicable

Withdrawn

• Conditions: Spinal Cord Stimulation; Insulin Secretion
• Interventions: Device: No stimulation; Device: BurstDR stimulation; Device: Tonic stimulation

• Registration Number: NCT05794776
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study Start: 2023-03-16
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No stimulation	No stimulation	No spinal cord stimulation during hyperglycemic clamp
BurstDR stimulation	BurstDR stimulation	BurstDR spinal cord stimulation during hyperglycemic clamp
Tonic stimulation	Tonic stimulation	Tonic spinal cord stimulation during hyperglycemic clamp

Primary Outcome Measures

Name	Time	Method
First and second phase of insulin secretion	Insulinsecretion during clamp (2 hours)	Modulation of insulin secretion by spinal cord stimulation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany