Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Transcutaneous vagal nerve stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will be assigned to either transcutaneous vagal nerve stimulation or sham for the first session, then switch to the other condition for their second session after a 1 week washout period.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Mild Cognitive Impairment; Vagal Nerve Stimulation; tVNS; Alzheimer's disease