Noninvasive Vagus Nerve Stimulation (VNS) for Neuromotor Adaptations

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Young Adults

In brief

The study will examine how electrical stimulation of vagus nerve (i.e. nerve around the outer ear) from the skin surface during motor training influences a brain hormone (called norepinephrine), brain activity, and motor performance.

Key facts

Study ID

NCT03628976

Run by

Georgia Institute of Technology

People needed

24

Starts

2019-05-20

Expected to finish

2021-06-28

Last updated by the study team

2022-09-29

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women in the age range of 18-39 years will be recruited. All subjects will be healthy and right-handed. Subjects will match the ethnic distribution in the local community.

You may not qualify if…

• To ensure the safety associated with TMS and transcutaneous afferent vagus nerve stimulation, following adults will be excluded as in our previous studies (Buharin et al. 2013, 2014) and following the standard recommendations (Keel et al. 2001):
• Younger than 18 years old or older than 39 years old
• Left-handed
• Skilled use of hands (e.g. professional musician)
• High blood pressure (>140/90 mmHg)
• Had cardiovascular problems
• Obese (Body Mass Index: > 30 kg/m2)
• Had sensory deficits in your limb
• Had alcoholism
• Had psychiatric disorders
• Had an adverse reaction to TMS (a technique for non-invasive neural stimulation from the brain)
• Had a seizure (an abnormal phenomenon of the brain marked by temporary abnormal neuronal activity. Symptoms include involuntary changes in body movement or function, sensation, awareness, or behavior.)
• Someone in your family has epilepsy (recurrent seizures marking excessive synchronous neuronal activity in the brain)
• Had an EEG (measurement of the electrical activity of the brain through the use of surface electrodes placed on the scalp) for clinical diagnosis
• Had a stroke (the loss of brain function due to an interruption in the blood supply to the brain)
• Had a head injury (include neurosurgery) that required a visit to a hospital
• Suffer from frequent or severe headaches (e.g., migraine headaches within the last six months)
• Have any metal permanently in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding or metal work. Piercings and other metals on your head are OK if they will be removed before the study.
• Have any implanted devices such as cardiac pacemakers (a medical device that uses electrical signals to regulate heart beat), medical pumps, or intra-cardiac lines
• Had any other brain-related condition
• Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
• Had severe disease such as cardiologic, pulmonary, renal, endocrinal (hyperthyroidism or hypothyroidism), gastrointestinal or others.
• Taking any medications other than over-the-counter medicine
• Suspect you might be pregnant (if woman)
• Have hearing problems, such as impaired hearing, tinnitus, etc.

Where it is running

• Human Neuromuscular Physiology Lab — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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