Neuromodulation of Cognition in Older Adults

NCT02137122 | Completed Results FDA Device

• 3 other identifiers: IRB201400328-N5KL2TR0014291K01AG050707-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cognitive Training + Active tDCS

EXPERIMENTAL

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

Cognitive Training + Sham tDCS

SHAM COMPARATOR

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

Interventions

Sham Stimulation DEVICE

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

Also known as: Soterix 1x1 DC stimulator

Cognitive Training + Sham tDCS

Transcranial Direct Current Stimulation DEVICE

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

Also known as: Soterix 1x1

Cognitive Training + Active tDCS

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

McKnight Brain Institute

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• 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.

  PMID: 31998111 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Adam Woods
• Organization: University of Florida

ajwoods@phhp.ufl.edu

352-294-5842

Study Officials

• Adam J Woods, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: January 14, 2015
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2023-05

Locations

US (2)