Neuromodulation of Cognition in Older Adults

NCT ID: NCT02137122

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-14
• Study Completion Date: 2022-02-08

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.

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.

Group Type: SHAM_COMPARATOR

Sham Stimulation

Intervention Type: DEVICE

Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.

Interventions

Sham Stimulation

Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.

Intervention Type: DEVICE

Transcranial Direct Current Stimulation

Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.

Intervention Type: DEVICE

Other Intervention Names

Soterix 1x1 DC stimulator; Soterix 1x1

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam J Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

McKnight Brain Institute

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31998111 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5KL2TR001429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K01AG050707-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201400328-N

Identifier Type: -

Identifier Source: org_study_id