Augmenting Cognitive Training In Older Adults

Not Applicable

Completed

• Conditions: Aging
• Interventions: Behavioral: Cognitive Training; Device: tDCS (active stimulation); Behavioral: Educational Training; Device: tDCS (sham stimulation)

• Registration Number: NCT02851511
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-08-01
• Study Start: 2017-08-08
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Results First Submitted: 2023-05-01
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-15
• Results First Posted: 2023-07-17
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Training + Active Stimulation	Cognitive Training	This arm receives cognitive training combined with active tDCS.
Cognitive Training + Sham Stimulation	Cognitive Training	This arm receives cognitive training combined with sham tDCS.
Cognitive Training + Active Stimulation	tDCS (active stimulation)	This arm receives cognitive training combined with active tDCS.
Educational Training + Active Stimulation	Educational Training	This arm receives educational training combined with active tDCS.
Cognitive Training + Sham Stimulation	tDCS (sham stimulation)	This arm receives cognitive training combined with sham tDCS.
Educational Training + Active Stimulation	tDCS (active stimulation)	This arm receives educational training combined with active tDCS.
Educational Training + Sham Stimulation	Educational Training	This arm receives educational training combined with sham tDCS.
Educational Training + Sham Stimulation	tDCS (sham stimulation)	This arm receives educational training combined with sham tDCS.

Primary Outcome Measures

Name	Time	Method
Improvement in Cognitive Ability.	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).

Secondary Outcome Measures

Name	Time	Method
Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)	Baseline to post assessment (3 months).	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.

Trial Locations

Locations (3)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Village of Gainesville; 🇺🇸 Gainesville, Florida, United States

University of Florida McKnight Brain Institute; 🇺🇸 Gainesville, Florida, United States