Augmenting Cognitive Training In Older Adults (ACT)
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ClinicalTrials.gov Identifier: NCT02851511 |
Recruitment Status :
Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : September 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Behavioral: Cognitive Training Device: tDCS (active stimulation) Device: tDCS (sham stimulation) Behavioral: Educational Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 306 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Augmenting Cognitive Training In Older Adults |
Actual Study Start Date : | August 8, 2017 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Cognitive Training + Active Stimulation
This arm receives cognitive training combined with active tDCS.
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Behavioral: Cognitive Training
Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal. Device: tDCS (active stimulation) 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). |
Experimental: Cognitive Training + Sham Stimulation
This arm receives cognitive training combined with sham tDCS.
|
Behavioral: Cognitive Training
Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal. Device: tDCS (sham stimulation) 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. |
Experimental: Educational Training + Active Stimulation
This arm receives educational training combined with active tDCS.
|
Device: tDCS (active stimulation)
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). Behavioral: Educational Training 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. |
Experimental: Educational Training + Sham Stimulation
This arm receives educational training combined with sham tDCS.
|
Device: tDCS (sham stimulation)
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. Behavioral: Educational Training 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. |
- Improvement in cognitive ability. [ Time Frame: Change from baseline to post assessment (3 months). ]Composite measure of cognitive ability as defined by NIH toolbox fluid cognition score.

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Ages Eligible for Study: | 65 Years to 89 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851511
United States, Arizona | |
University of Arizona | |
Tucson, Arizona, United States, 85721 | |
United States, Florida | |
Village of Gainesville | |
Gainesville, Florida, United States, 32606 | |
University of Florida McKnight Brain Institute | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Adam Woods, Ph.D | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT02851511 |
Other Study ID Numbers: |
IRB201600785-N-R R01AG054077 ( U.S. NIH Grant/Contract ) RF1AG071469 ( U.S. NIH Grant/Contract ) AWD00532 ( Other Identifier: UFIRST ) |
First Posted: | August 1, 2016 Key Record Dates |
Last Update Posted: | September 22, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |