Augmenting Cognitive Training In Older Adults
ACT
4 other identifiers
interventional
379
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
August 1, 2016
CompletedStudy Start
First participant enrolled
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedResults Posted
Study results publicly available
July 17, 2023
CompletedApril 17, 2024
June 1, 2023
4.7 years
July 7, 2016
May 1, 2023
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Cognitive Ability.
Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).
Change from baseline to post assessment (3 months).
Secondary Outcomes (1)
Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)
Baseline to post assessment (3 months).
Study Arms (4)
Cognitive Training + Active Stimulation
EXPERIMENTALThis arm receives cognitive training combined with active tDCS.
Cognitive Training + Sham Stimulation
EXPERIMENTALThis arm receives cognitive training combined with sham tDCS.
Educational Training + Active Stimulation
EXPERIMENTALThis arm receives educational training combined with active tDCS.
Educational Training + Sham Stimulation
EXPERIMENTALThis arm receives educational training combined with sham tDCS.
Interventions
Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
Eligibility Criteria
You may qualify if:
- 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.
- Evidence of age-related cognitive decline in the Cognitive Training assessment defined by performance below the 80th percentile.
- Ability to participate in the intervention and attend training sessions; willingness to be randomized to either treatment group.
You may not qualify if:
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- 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).
- Past opportunistic brain infection.
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
- Unstable (e.g., cancer other than basal cell skin) and chronic (e.g. severe diabetes) medical conditions.
- MRI contraindications (e.g., claustrophobia, metal implants).
- Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
- Currently on GABA-ergic or glutamatergic medications, or on sodium channel blockers.
- Left-handedness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- University of Arizonacollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (3)
University of Arizona
Tucson, Arizona, 85721, United States
Village of Gainesville
Gainesville, Florida, 32606, United States
University of Florida McKnight Brain Institute
Gainesville, Florida, 32610, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Woods, Ph.D.
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Woods, Ph.D
University of Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2016
First Posted
August 1, 2016
Study Start
August 8, 2017
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
April 17, 2024
Results First Posted
July 17, 2023
Record last verified: 2023-06