Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
Status: | Recruiting |
---|---|
Conditions: | Cognitive Studies, Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 60 - 89 |
Updated: | 3/24/2019 |
Start Date: | January 1, 2018 |
End Date: | June 30, 2020 |
Contact: | Aidan J Murphy, B.A. |
Email: | aidanjmurphy@phhp.ufl.edu |
Phone: | 352 548 6000 |
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).
(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).
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.
(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.
Inclusion Criteria:
- Diagnosed with amnestic mild cognitive impairment/mild Alzheimer's disease
- Preservation of independence in functional abilities
- Healthy aged adults without MCI to serve as control group
Exclusion Criteria:
- Other medical or neurological conditions that may be associated with significant
impaired cognition (e..g, moderate to severe traumatic brain injury, epilepsy, etc...)
- Vascular dementia or other non-AD spectrum diagnosed neurodegenerative disorders
- Significant current depression
- Uncorrected vision/hearing loss
- Unable to undergo MRI exam
We found this trial at
2
sites
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: John B Williamson, Ph.D
Phone: 352-548-6000
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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