Brain ActivityNCT02969330
Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli
A study testing Stimulator and Glucose in people with Brain Activity and Glucose Control, run by Tel Aviv University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Activity, Glucose Control
- What is being tested?
- Stimulator and Glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age 18-65 years old.
- Body mass index 18 to 25 kg/m2
- Capable of giving informed consent
Who cannot join
- Pregnancy, or nursing
- Permanent pacemakers
- Metal prosthesis
- Skin disease
- Claustrophobia
- History of neurological disorders
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Brain Activity, Glucose Control
- Being tested
- Stimulator, Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulatorDevice
GlucoseDietary supplement
300ml tap water with 75g glucose
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Experimental | Glucose ingestion Receives: Dietary Supplement: Glucose |
| PES | Active comparator | Single session of short PES treatment before glucose ingestion. Receives: Device: Stimulator; Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.
Measured: changes from baseline to 30 minutes after glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Uri Nevo, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969330
- Sponsor's protocol ID
- 2366-16-SMC
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969330
- Acronym / sponsor ID
- 2366-16-SMC
- Conditions
- Brain Activity, Glucose Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- Dec 2016
- Primary completion
- Jan 2018 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose | Experimental | Dietary Supplement: GlucoseGlucose ingestion |
| PES | Active comparator | Device: Stimulator, Dietary Supplement: GlucoseSingle session of short PES treatment before glucose ingestion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age 18-65 years old.
- Body mass index 18 to 25 kg/m2
- Capable of giving informed consent
Key exclusion criteria (6 listed)
- Pregnancy, or nursing
- Permanent pacemakers
- Metal prosthesis
- Skin disease
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulator | Device | PES |
| Glucose300ml tap water with 75g glucose | Dietary supplement | Glucose, PES |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulator and Glucose in people with Brain Activity and Glucose Control, run by Tel Aviv University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Nevo, PhD (972-3-6407542, nevouri@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.