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

Brain Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02969330
• Other study ID #: 2366-16-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: November 17, 2016
• Start date: December 2016

Study information

• Verified date: November 2016
• Source: Tel Aviv University
• Contact: Uri Nevo, PhD
• Phone: 972-3-6407542
• Email: nevouri[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Brain Activity
• Glucose Control

Intervention

Device:
• Stimulator

Dietary Supplement:
• Glucose
300ml tap water with 75g glucose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.		changes from baseline to 30 minutes after glucose ingestion	No