Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli

November 17, 2016 updated by: Uri Nevo, Tel Aviv University

Effect of Short Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli Evaluated by BOLD and Functional Diffusion MRI: a Crossover Pilot Study

The aims of this study are twofold: (1) to develop an innovative approach for studying brain glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on brain and brain-stem targets, associated with control of food intake and energy expenditure, in response to glucose stimuli, in healthy volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-65 years old.
  • Body mass index 18 to 25 kg/m2
  • Capable of giving informed consent

Exclusion Criteria:

  • Pregnancy, or nursing
  • Permanent pacemakers
  • Metal prosthesis
  • Skin disease
  • Claustrophobia
  • History of neurological disorders

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucose
Glucose ingestion
Dietary supplement: Glucose
300ml tap water with 75g glucose
Active Comparator: PES
Single session of short PES treatment before glucose ingestion.
Dietary supplement: Glucose
300ml tap water with 75g glucose
Device: Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.
Time Frame: changes from baseline to 30 minutes after glucose ingestion
changes from baseline to 30 minutes after glucose ingestion

Collaborators and Investigators

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

Sponsor

Tel Aviv University

Collaborators

Sheba Medical Center

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

December 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2366-16-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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