Neuromodulation of Cognition in Older Adults

Neuromodulation of Cognition in Older Adults: The Stimulated Brain Study

This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Sham Stimulation; Device: Transcranial Direct Current Stimulation

Detailed Description

The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot 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 enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Gainesville, Florida, United States, 32611
      • McKnight Brain Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women
• Age: 65 to 90 years
• English speaking
• Physically mobile
• working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.

Exclusion Criteria:

• Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
• Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
• 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., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
• Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
• Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
• Hearing or vision deficits that will not allow for standardized cognitive training.
• Left handedness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training + Active tDCS; Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation.	Device: Transcranial Direct Current Stimulation; Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.; Other Names: Soterix 1x1
Sham Comparator: Cognitive Training + Sham tDCS; Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation.	Device: Sham Stimulation; Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.; Other Names: Soterix 1x1 DC stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NIH Toolbox Fluid Cognition Composite Score	The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We used the change from baseline to two week post test in the NIH Toolbox Fluid Cognition Composite Score (FCC) to assess outcome. The uncorrected standard score of the FCC was used. The FCC is derived by averaging the standard scores of the NIH Toolbox Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting, and Pattern Comparison tests and then deriving standard scores based on this new distribution. The uncorrected standard score is on a scale of mean = 100, standard deviation = 15. Higher positive scores mean a greater improvement at the post test. Difference scores ranged from a minimum of -7 to a maximum of 19. FCC scores ranged from a minimum of 73 to a maximum of 112 in this sample. On a population level percentiles are reported from a minimum score of 59 to a maximum of 140, covering 99.3% of the population.	baseline up to two week post test

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Adam J Woods, PhD, University of Florida

Publications and helpful links

General Publications

• Nissim NR, O'Shea A, Indahlastari A, Kraft JN, von Mering O, Aksu S, Porges E, Cohen R, Woods AJ. Effects of Transcranial Direct Current Stimulation Paired With Cognitive Training on Functional Connectivity of the Working Memory Network in Older Adults. Front Aging Neurosci. 2019 Dec 16;11:340. doi: 10.3389/fnagi.2019.00340. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2015
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Volunteers
• Other Study ID Numbers: IRB201400328-N; 5KL2TR001429 (U.S. NIH Grant/Contract); 1K01AG050707-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes