transcutaneous vagal nerve stimulation
DeviceNon-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
NCT Number: NCT03359902
Patients with amnestic mild cognitive impairment (MCI) often have compromised quality of life (QOL). Cognitive impairment is a major contributor to decrements in QOL and progression of MCI often leads to loss of independence and withdrawal from social participation. MCI, in many patients, is an early expression of neurodegenerative disease. Patients with MCI frequently convert to Alzheimer's disease (AD) (12-16 percent by some estimates per year). Treatments for MCI are of limited scope and availability and of limited effectiveness. Thus, there is great need for treatments that can improve cognition and extend QOL in patients with MCI. The investigators propose to investigate the effect of a non-invasive and safe intervention that should have direct influence on brain systems underlying AD, transcutaneous vagal nerve stimulation (tVNS).
Looking for future studies?
Notify Me60 year–89 year
All sexes
Interventional
Not applicable
Malcom Randall VA Medical Center, Gainesville, Florida, United States
Patients with amnestic mild cognitive impairment (MCI) often have compromised quality of life (QOL). Cognitive impairment is a major contributor to decrements in QOL and progression of MCI often leads to loss of independence and withdrawal from social participation. MCI, in many patients, is an early expression of neurodegenerative disease. Patients with MCI frequently convert to Alzheimer's disease (AD) (12-16 percent by some estimates per year). Treatments for MCI are of limited scope and availability and of limited effectiveness. Thus, there is great need for treatments that can improve cognition and extend QOL in patients with MCI. The investigators propose to investigate the effect of a non-invasive and safe intervention that should have direct influence on brain systems underlying AD, transcutaneous vagal nerve stimulation (tVNS). Transcutaneous vagal nerve stimulation (tVNS) may ameliorate symptoms of MCI. The investigators have demonstrated, in patients with epilepsy, that VNS improves memory; however, tVNS has not been used to treat patients with MCI. tVNS can now be performed without surgery by transcutaneous stimulation of the auricular branch with electrodes on the external ear. tVNS has the potential to improve cognition and may even alter the course of decline in patients with MCI. The investigators will employ a multimodal MRI-based neuroimaging approach combined with comprehensive and targeted cognitive testing to assess changes with tVNS in cognition in patients with MCI.
The investigators will evaluate the effects of tVNS on patients who have been diagnosed with MCI as well as healthy older controls. Very little in the way of mechanistic data or understanding of individual differences in response to tVNS in MCI/AD has been published. Thus, this is a necessary study to evaluate the potential utility of tVNS to enhance cognitive performance in patients with MCI. These data may serve as a platform for supporting the development of a clinical treatment trial with this technology.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
Sham stimulation will be performed using electrodes placed on earlobe
Time frame: 30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list
The Rey Auditory Verbal Learning Test (RAVLT) is a verbal learning and memory task with a 15-item word list learned over 5 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 15) after a 30 minute delay.
University of Florida
Other
Acronym: TVNS MCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06347172
Alzheimer Disease, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT05574400
Alzheimer Disease, Brain Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT03933696
Alzheimer Disease, Brain Diseases
New Brunswick, New Jersey, United States
View Trial DetailsNCT05584241
Alzheimer Disease, Amnestic Mild Cognitive Disorder
Ann Arbor, Michigan, United States
View Trial Details