tVNS and Obesity-related Mechanisms
Researchers are investigating a new technique called transcutaneous Vagus Nerve Stimulation (tVNS) to understand its effects on individuals who are overweight or obese. This method involves using a mild electrical current on a specific part of the ear. The study aims to discover if this stimulation can help reduce inflammation within the body and if these changes are connected to improvements in mood and motivation. Participants will use a small device at home for two 14-day periods, separated by a break. Throughout the study, various tests, including blood samples and brain scans, will be used to measure how tVNS might be working. This research could offer new insights into managing conditions related to being overweight or obese.
At a glance
What is this study about?
This research study is looking into a gentle electrical treatment called transcutaneous Vagus Nerve Stimulation (tVNS). The vagus nerve is like a major information highway in your body, connecting your brain to many important organs. Scientists believe that gently stimulating this nerve, by placing a small device on your ear, might have positive effects throughout your body and brain.
The main goal is to see if tVNS can help reduce inflammation – which is your body's response to injury or illness – in people who are overweight or obese. They also want to find out if reducing this inflammation is linked to changes in how people feel, especially their mood and what motivates them. Understanding these connections could open new doors for supporting individuals who are overweight or obese.
Researchers will compare two different levels of stimulation: a standard one and a very low one. By doing this, they hope to get a clearer picture of whether the active stimulation really makes a difference. They'll be looking carefully at how the body responds, including checking blood samples for signs of inflammation and using special brain scans to see if there are changes in brain activity, as well as asking about mood and motivation through questionnaires.
Key takeaways
- This study explores a gentle electrical treatment (tVNS) for overweight/obesity.
- It aims to see how tVNS affects inflammation, mood, and motivation.
- Participants will use a small device at home for two 14-day periods.
- The study involves blood tests, brain scans, and questionnaires.
- Your safety and right to withdraw are top priorities.
- It helps scientists understand new ways to support health.
Who may be eligible?
The study is looking for healthy individuals between 18 and 40 years old who are considered overweight or obese. To be eligible, your Body Mass Index (BMI) should be between 27 and 35. Make sure you fully understand and agree to take part by signing a consent form.
There are several reasons why you might not be able to join. These include certain past or present medical conditions like brain injuries, epilepsy, severe heart disease, or diabetes. If you've had a significant weight change (more than 10%) in the last six months, or if your higher BMI is mainly due to muscle (like in athletes), you wouldn't be able to participate.
Also, if you've recently taken certain medications for mental health, metabolic, or nerve conditions, or anti-inflammatory drugs, you might not be eligible. People with metal implants, claustrophobia, active medical devices like pacemakers, or skin issues on their outer right ear can't take part due to the type of tests and treatments used. Pregnant or breastfeeding women are also excluded.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 40 years old?
- Is your BMI between 27 and 35?
- Do you have good general health, without severe medical conditions?
- Have you had no major weight changes (over 10%) in the last 6 months?
- Are you able to undergo MRI scans (no metal implants or claustrophobia)?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you join this study, you'll be asked to visit the lab four times. Your first visit (t0) will be before any stimulation begins. During this visit, researchers will measure your mood, motivation, inflammation levels through blood tests, body measurements, and other health markers. You'll also rate pictures of food to help with a task later on.
Then, you'll start using a small tVNS device at home for 14 days. This will either be a standard stimulation or a very low one. After these 14 days, you'll have your second lab visit (t1) for more assessments. There will then be a 7-day break where you don't use the device. After this break, you'll have your third visit (t2) to learn how to use the device for the next phase and have more measurements taken.
You'll then use the other type of stimulation (standard or low) for another 14 days at home. Finally, after this second stimulation period, you'll have your fourth and final lab visit (t3) for the last set of assessments. Throughout the study, you'll also be asked to complete short assessments on your mood and motivation using a study app. The total duration of your active participation, including stimulation periods and breaks, will be about 6 weeks.
Potential risks and benefits
Locations (1)
- Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of BonnVerified postcodeBonn, Germany
Common questions
What is tVNS?
tVNS uses a small device that sends a mild electrical pulse to a specific nerve in your ear. It's thought to have effects on your brain and body.
Will I know if I'm getting the 'real' treatment?
No, you won't know if you're receiving the standard or the very low stimulation. This helps ensure the study results are as clear as possible.
How long will I have to use the device?
You'll use the device at home for two separate periods of 14 days each, with a 7-day break in between.
What kind of tests will I have?
You'll have blood tests, body measurements, answer questions about your mood, and undergo special brain scans (MRIs).
What happens if I change my mind?
You can decide to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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