NCT04050046

Brief Summary

This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. The investigators aim to enhance participants ability to perform tasks of memory, attention, processing speed and other areas of cognition. Additionally, researchers are interested in the ability of the brain to adapt to change-neuroplasticity. Neuroplasticity is thought to impact how individuals respond to cognitive training and tDCS. In order to look at individual differences in neuroplasticity transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, will be used. Individual responses to TMS can be used as a marker of neuroplastic changes in brain function, in order to reveal the relationship between brain plasticity and tDCS-induced changes in cognitive ability.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

July 30, 2019

Last Update Submit

February 8, 2021

Conditions

Normal Aging

Keywords

non-invasive brain stimulationcognitiontranscranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

  • Executive Function

    Change in tDCS induced executive function as measured by the Delis-Kaplan Executive Function Systems (DKEFS) test. DKEFS utilizes a scaled score which ranges from 1-20 with scores between 8-12 considered average.

    baseline, day 5, 2 week, 2 months

Secondary Outcomes (1)

  • TMS brain activation

    2 week

Study Arms (2)

Real tDCS + CBCT

ACTIVE COMPARATOR

20 minutes of 2.0mA of tDCS for 5 consecutive days

Device: Transcranial Direct Current StimulationBehavioral: Computer-based cognitive therapy (CBCT)

Sham + CBCT

SHAM COMPARATOR

Sham stimulation closely imitates reals tDCS 30 second ramp-up / ramp-down

Device: Transcranial Direct Current StimulationBehavioral: Computer-based cognitive therapy (CBCT)

Interventions

Transcranial Direct Current StimulationDEVICE

tDCS is a neuromodulatory technique that delivers a small electric current (about the equivalent of a 9V battery) to the head. A fixed current between 1 and 2 mA is typically applied. tDCS works by applying a positive (anodal) or negative (cathodal) current via electrodes to an area, facilitating the depolarization or hyperpolarization of neurons, respectively.

Real tDCS + CBCTSham + CBCT
Computer-based cognitive therapy (CBCT)BEHAVIORAL

Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct.

Real tDCS + CBCTSham + CBCT

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Normal cognition
  • English as their native language

You may not qualify if:

  • History of neurological disorders
  • History of head injury with unconsciousness lasting more than 5 minutes
  • History of psychiatric disorders
  • Currently abusing alcohol or drugs (prescription or otherwise)
  • History of epilepsy or seizures within the past 6 months
  • Previous brain surgery
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to either receive real or sham tDCS without the option of crossover.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 8, 2019

Study Start

August 18, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 11, 2021

Record last verified: 2021-02