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

May 8, 2024 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BurstDR stimulation
BurstDR spinal cord stimulation during hyperglycemic clamp
Device: BurstDR stimulation
BurstDR spinal cord stimulation
Experimental: Tonic stimulation
Tonic spinal cord stimulation during hyperglycemic clamp
Device: Tonic stimulation
Tonic spinal cord stimulation
Placebo Comparator: No stimulation
No spinal cord stimulation during hyperglycemic clamp
Device: No stimulation
Stimulator is switched off
Other Names:
  • No spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First and second phase of insulin secretion
Time Frame: Insulinsecretion during clamp (2 hours)
Modulation of insulin secretion by spinal cord stimulation
Insulinsecretion during clamp (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Mean Square of Successive Differences (RMSSD)
Time Frame: Heart rate variablity during stimulation (10 minutes)
Modulation of heart rate variability by spinal cord stimulation assessed by electrocardiography
Heart rate variablity during stimulation (10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Matthias Morgalla, Prof., Universitaetsklinikum Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 047/2022BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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