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Augmenting Cognitive Training In Older Adults (ACT)

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ClinicalTrials.gov Identifier: NCT02851511
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : February 24, 2020
Sponsor:
Collaborators:
University of Arizona
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Cognitive Training Device: tDCS (active stimulation) Device: tDCS (sham stimulation) Behavioral: Educational Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1116 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 : August 2022
Estimated Study Completion Date : August 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Training + Active Stimulation
This arm receives cognitive training combined with active tDCS.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Adam Woods, Ph.D. 352-294-5842 ajwoods@ufl.edu

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
United States, Florida
Village of Gainesville Recruiting
Gainesville, Florida, United States, 32606
University of Florida McKnight Brain Institute Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Adam J. Woods, PhD         
Sponsors and Collaborators
University of Florida
University of Arizona
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Adam Woods, Ph.D University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02851511    
Other Study ID Numbers: IRB201600785-N
R01AG054077 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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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