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

NCT ID: NCT05794776

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Stimulation Insulin Secretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BurstDR stimulation

BurstDR spinal cord stimulation during hyperglycemic clamp

Group Type EXPERIMENTAL

BurstDR stimulation

Intervention Type DEVICE

BurstDR spinal cord stimulation

Tonic stimulation

Tonic spinal cord stimulation during hyperglycemic clamp

Group Type EXPERIMENTAL

Tonic stimulation

Intervention Type DEVICE

Tonic spinal cord stimulation

No stimulation

No spinal cord stimulation during hyperglycemic clamp

Group Type PLACEBO_COMPARATOR

No stimulation

Intervention Type DEVICE

Stimulator is switched off

Interventions

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BurstDR stimulation

BurstDR spinal cord stimulation

Intervention Type DEVICE

Tonic stimulation

Tonic spinal cord stimulation

Intervention Type DEVICE

No stimulation

Stimulator is switched off

Intervention Type DEVICE

Other Intervention Names

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No spinal cord stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Morgalla, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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047/2022BO2

Identifier Type: -

Identifier Source: org_study_id

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