Glucose and Non-Invasive Brain Stimulation

NCT04031404 | Terminated Results FDA Device

• 1 other identifier: 19-1451
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• Motor Evoked Potential (MEP)

  Change in MEP over time to indicate changes in motor cortex excitability

  Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

• TMS Evoked Potential (TEP)

  The TMS Evoked Potential (TEP) is the difference in microvolts from 25 milliseconds after a TMS pulse versus pre-TMS such that greater values indicate greater motor cortex excitability. The measure of the change in TEP over time since either glucose or water was consumed approximates a z-distribution with a range of -20 to 20 with central distribution measures of zero. TEPs were source localized and reported using a pseudo-neural activity index (PNAI) expressing source activation in relation to pre-TMS pulse trial baseline. The difference in the source peaks corresponding to the early P25 component have been reported as differences from baseline. Higher values indicate greater cortical excitation, consistent with the study hypothesis.

  Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

Secondary Outcomes (3)

• EEG Measure of Alpha Asymmetry Oscillations

  Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

• EEG Measure of Frontal Midline Theta Oscillations

  Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

• Working Memory Task Accuracy

  Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.

Study Arms (2)

Glucose drink followed by placebo

EXPERIMENTAL

Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.

Device: Single-pulse TMS

Placebo followed by glucose drink

EXPERIMENTAL

Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.

Device: Single-pulse TMS

Interventions

Single-pulse TMS DEVICE

Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).

Also known as: MagPro X100

Glucose drink followed by placebo; Placebo followed by glucose drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UNC Medical School Wing C

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Stitt I, Zhou ZC, Radtke-Schuller S, Frohlich F. Arousal dependent modulation of thalamo-cortical functional interaction. Nat Commun. 2018 Jun 25;9(1):2455. doi: 10.1038/s41467-018-04785-6.

  PMID: 29941957 BACKGROUND

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The end sample sizes are lower than intended as the trial was ended early due to COVID-19-related research drawdowns. Technical limitations in the Electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) data collection resulted in N=1 and N=3 dataset to be excluded from final analyses, respectively.

Results Point of Contact

• Title: Rachel B. Force, PhD
• Organization: University of North Carolina at Chapel Hill

rachel_force@med.unc.edu

9199669929

Study Officials

• Flavio Frohlich

  Carolina Center for Neurostimulation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher that interacts with the subject will not know whether the subject consumed the glucose drink or the placebo.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 24, 2019
• Study Start: September 11, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 27, 2021
• Results First Posted: September 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: IRB, IEC, or REB approval, as applicable, and execution of a data use/sharing agreement with UNC.

Locations

US (1)