NCT05794776

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 17, 2023

Last Update Submit

May 8, 2024

Conditions

Spinal Cord StimulationInsulin Secretion

Outcome Measures

Primary Outcomes (1)

  • First and second phase of insulin secretion

    Modulation of insulin secretion by spinal cord stimulation

    Insulinsecretion during clamp (2 hours)

Secondary Outcomes (1)

  • Root Mean Square of Successive Differences (RMSSD)

    Heart rate variablity during stimulation (10 minutes)

Study Arms (3)

BurstDR stimulation

EXPERIMENTAL

BurstDR spinal cord stimulation during hyperglycemic clamp

Device: BurstDR stimulation

Tonic stimulation

EXPERIMENTAL

Tonic spinal cord stimulation during hyperglycemic clamp

Device: Tonic stimulation

No stimulation

PLACEBO COMPARATOR

No spinal cord stimulation during hyperglycemic clamp

Device: No stimulation

Interventions

BurstDR stimulationDEVICE

BurstDR spinal cord stimulation

BurstDR stimulation
Tonic stimulationDEVICE

Tonic spinal cord stimulation

Tonic stimulation
No stimulationDEVICE

Stimulator is switched off

Also known as: No spinal cord stimulation
No stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • implanted BurstDR spinal cord stimulating system
  • body mass index 18-25 kg/m2

You may not qualify if:

  • neurological and psychatric diseases
  • decompensated diabetes mellitus
  • hemoglobin \< 13 g/dl
  • thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Study Officials

  • Matthias Morgalla, Prof.

    Universitaetsklinikum Tuebingen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

April 3, 2023

Study Start

March 16, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

May 10, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)