Clinical trial NCT02851511: Augmenting Cognitive Training In Older Adults
Official title: Augmenting Cognitive Training In Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: National Institute on Aging (NIA)
First posted: 2016-08-01
Enrollment: 379
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A two-phase adaptive randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance neurocognitive function, brain function, and functional outcomes from CT, with combined CT and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12 months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs. active cognitive tasks will predict individual response to tDCS.


Eligibility criteria: Inclusion criteria:

1. Age 65 to 89 years; this age group was selected because it is at high risk of age-related cognitive decline and have a sufficiently long life expectancy to participate in the study.
2. Evidence of age-related cognitive decline in the Cognitive Training assessment defined by performance below the 80th percentile.
3. Ability to participate in the intervention and attend training sessions; willingness to be randomized to either treatment group.

Exclusion criteria:

1. Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
2. Evidence of cognitive impairment (as defined by NACC UDS performance below 1.5 standard deviations on age/sex/education normative data in at least one cognitive domain).
3. Past opportunistic brain infection.
4. Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
5. Unstable (e.g., cancer other than basal cell skin) and chronic (e.g. severe diabetes) medical conditions.
6. MRI contraindications (e.g., claustrophobia, metal implants).
7. Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
8. Currently on GABA-ergic or glutamatergic medications, or on sodium channel blockers.
9. Left-handedness.

Primary outcomes:
measure: Improvement in Cognitive Ability.
timeFrame: Change from baseline to post assessment (3 months).
Secondary outcomes:
measure: Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)
timeFrame: Baseline to post assessment (3 months).
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Gainesville
country: United States
facility: Village of Gainesville
state: Florida
city: Gainesville
country: United States
facility: University of Florida McKnight Brain Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Adam Woods, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: