ClinicalTrials.Veeva

Menu

Glucose and Non-Invasive Brain Stimulation

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Terminated

Conditions

Glucose Metabolism Disorders

Treatments

Device: Single-pulse TMS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04031404
19-1451

Details and patient eligibility

About

Purpose: In this study, the investigators will delineate how brain network dynamics are modulated by experimentally induced elevated blood glucose levels and examine how glucose levels gate neuronal excitability measured by the response to TMS.

Participants: Participants must be between the ages of 18 and 65 with no known diabetes, no known adverse reaction to finger prick blood draw, and no known neurological or psychiatric illness. Participants must have a body-mass index less than 30.

Procedures: Participants will consume either a drink that contains 75 g of glucose or a placebo, and their response to TMS will be measured to examine the effect of glucose on motor cortex excitability.

Full description

This study will be a placebo-controlled study that investigates brain function with both electroencephalography (EEG) and TMS. On each study visit, a drink (either glucose drink or water) is administered after baseline assessment of fasting glucose. Changes in brain activity and excitability will be measured with resting-state EEG. Periodic high-density EEG of resting-state brain activity and activity during a working memory task will be performed before the administration of the drink, immediately after the administration of the drink, as well as 30 minutes, 60 minutes, 120 minutes, 150 minutes, and 180 minutes after the administration of the drink. The spectral content of the EEG signal will be investigated to identify the relative presence of cortical oscillations. Primarily, there will be a focus on theta (4-8 Hz) and alpha (8-12 Hz) oscillations.

Previous literature indicates that theta and alpha oscillations represent an engaged and disengaged cortical state, respectively [1]. Alpha and theta oscillations are implicated in cognitive function and are altered in depression. Therefore, this study aims to identify a decrease in frontal theta oscillations and an increase in left frontal alpha oscillations, two defining features of impaired top-down control and mood regulation, in response to the glucose drink contrasted with the response to the placebo.

The study will also examine how glucose levels gate neuronal excitability measured by the response to TMS. Cortical excitability will be measured by applying TMS pulses to the motor cortex and measuring the response in the form of a motor evoked potential by electromyography (EMG). TMS will be applied before the administration of the drink, immediately after the administration of the drink, as well as 30 minutes, 60 minutes, 120 minutes, 150 minutes, and 180 minutes after the administration of the drink. Changes in blood glucose will be monitored over this time interval as well.

Enrollment

23 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Right-handed
  • BMI <30
  • Free of major neurological conditions and diabetes

Exclusion criteria

  • Diabetes
  • Adverse reaction to finger prick blood draw
  • Known neurological or psychiatric illness
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • Cardiac pacemaker
  • Any other implanted electronic device
  • History of current traumatic brain injury
  • Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

23 participants in 2 patient groups

Glucose drink followed by placebo
Experimental group
Description:
Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.
Treatment:
Device: Single-pulse TMS
Placebo followed by glucose drink
Experimental group
Description:
Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.
Treatment:
Device: Single-pulse TMS

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems