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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05794776
Collaborator
(none)
10
Enrollment
1
Location
3
Arms
14.5
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BurstDR stimulation
  • Device: Tonic stimulation
  • Device: No stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain
Actual Study Start Date :
Mar 16, 2023
Anticipated Primary Completion Date :
Dec 12, 2023
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. First and second phase of insulin secretion [Insulinsecretion during clamp (2 hours)]

      Modulation of insulin secretion by spinal cord stimulation

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Tuebingen Tuebingen Germany 72076

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT05794776
    Other Study ID Numbers:
    • 047/2022BO2
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 6, 2023