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

University Hospital Tuebingen

Status: Withdrawn

Conditions: Insulin Secretion; Spinal Cord Stimulation

Treatments: Device: BurstDR stimulation; Device: Tonic stimulation; Device: No stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05794776

047/2022BO2

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

BurstDR stimulation

Experimental group

Description:

BurstDR spinal cord stimulation during hyperglycemic clamp

Treatment:

Device: BurstDR stimulation

Tonic stimulation

Experimental group

Description:

Tonic spinal cord stimulation during hyperglycemic clamp

Treatment:

Device: Tonic stimulation

No stimulation

Placebo Comparator group

Description:

No spinal cord stimulation during hyperglycemic clamp

Treatment:

Device: No stimulation