AgingACTNCT02851511
Augmenting Cognitive Training In Older Adults
A study testing Cognitive Training, tDCS (active stimulation) and Educational Training in people with Aging, run by University of Florida at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cognitive Training, tDCS (active stimulation) and Educational Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Aug 2017to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Village of Gainesville
Gainesville, Florida, 32606
University of Florida McKnight Brain Institute
Gainesville, Florida, 32610
University of Arizona
Tucson, Arizona, 85721
About this study
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.
- Conditions
- Aging
- Being tested
- Cognitive Training, tDCS (active stimulation), tDCS (sham stimulation), Educational Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation)Device
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).
tDCS (sham stimulation)Device
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training + Active Stimulation | Experimental | This arm receives cognitive training combined with active tDCS. Receives: Behavioral: Cognitive Training; Device: tDCS (active stimulation) |
| Cognitive Training + Sham Stimulation | Experimental | This arm receives cognitive training combined with sham tDCS. Receives: Behavioral: Cognitive Training; Device: tDCS (sham stimulation) |
| Educational Training + Active Stimulation | Experimental | This arm receives educational training combined with active tDCS. Receives: Device: tDCS (active stimulation); Behavioral: Educational Training |
| Educational Training + Sham Stimulation | Experimental | This arm receives educational training combined with sham tDCS. Receives: Device: tDCS (sham stimulation); Behavioral: Educational Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
POSIT BrainHQ Cognitive Training Composite Performance measure involves performance on the 8 selected cognitive training tasks set to the medium difficulty level and provides a measure of proximal performance on cognitive training tasks central to the cognitive training condition. The higher score indicates better performance. The range of POSIT Z-Score at 3-month is -1.04 to 1.75. the minimum and maximum for Cognitive training group and Education training group are (-0.24, 1.75) and (-1.04, 1.39), respectively.
Measured: Baseline to post assessment (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start8 Aug 2017
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Adam Woods, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851511
- Sponsor's protocol ID
- IRB201600785-N-R
- Other IDs
- R01AG054077, RF1AG071469, AWD00532
- Acronym
- ACT
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2016
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Cognitive Training In Older Adults
- ClinicalTrials.gov ID
- NCT02851511
- Acronym / sponsor ID
- ACT / IRB201600785-N-R
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Arizona, National Institute on Aging (NIA)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training + Active Stimulation | Experimental | Behavioral: Cognitive Training, Device: tDCS (active stimulation)This arm receives cognitive training combined with active tDCS. |
| Cognitive Training + Sham Stimulation | Experimental | Behavioral: Cognitive Training, Device: tDCS (sham stimulation)This arm receives cognitive training combined with sham tDCS. |
| Educational Training + Active Stimulation | Experimental | Device: tDCS (active stimulation), Behavioral: Educational TrainingThis arm receives educational training combined with active tDCS. |
| Educational Training + Sham Stimulation | Experimental | Device: tDCS (sham stimulation), Behavioral: Educational TrainingThis arm receives educational training combined with sham tDCS. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingCognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal. | Behavioural | Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation |
| 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). | Device | Cognitive Training + Active Stimulation, Educational Training + Active Stimulation |
| 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. | Device | Cognitive Training + Sham Stimulation, Educational Training + Sham Stimulation |
| Educational TrainingEducational 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. | Behavioural | Educational Training + Active Stimulation, Educational Training + Sham Stimulation |
Primary outcome
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 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).
1 secondary outcome
Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)
Time frame: Baseline to post assessment (3 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Woods, Ph.D principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training, tDCS (active stimulation) and Educational Training in people with Aging, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cognitive Ability. (time frame: Change from baseline to post assessment (3 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.