Noninvasive Brain Stimulation to Enhance Cognitive Training in Older Adults

NCT ID: NCT04050046

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-18
• Study Completion Date: 2018-08-01

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.

Detailed Description

Promising evidence suggests that cognitive training regimens may have some beneficial effects on cognition in older adults. However, the improvement from computer-based cognitive training (CBCT) diminish over time which highlights a fundamental challenge for CBCT interventions. Transcranial direct current stimulation (tDCS) can enhance certain cognitive skills, particularly when stimulation is combined with rehearsal of relevant behaviors. Importantly, these benefits have been shown to persist up to 2 months after the intervention.

This study will lay the groundwork for larger scale studies that will combine CBCT with neuromodulation, potentially leading to the development of a persistent, transferrable, multimodal technique to preserve cognition in older adults. In this study, participants will be randomly assigned to receive either real or sham tDCS for 5 consecutive days in conjunction with CBCT. The participant's cognition will be assessed with a neuropsychological assessment at baseline, 1 week, 2 weeks, and 2 months in order to determine any changes.

Additionally, transcranial magnetic stimulation (TMS) will be used to characterize the relationship between baseline differences in brain plasticity and cognitive changes induced by tDCS+CBCT. The effects of TMS on cortical activity have been shown to depend on a variety of neuroplasticity-related mechanisms. In this study, changes in motor physiology (called motor evoked potentials (MEPs)) induced by TMS will be used. Stimulation of the motor cortex with TMS induces robust, transient, and readily quantifiable changes in motor excitability, which are sensitive to changes in the mechanisms of neuroplasticity. Investigators hypothesize that individual variability in brain plasticity, measured by changes in MEP response to TMS, will predict the degree of cognitive benefit afforded by tDCS+CBCT.

Study Visits:

---------------- Visit 1 - Consent and Screening (2 hours) Review enrollment documents and conduct baseline neuropsychological assessment

---------------- Visit 2 - Visit 5 - tDCS + CBCT (30 minutes) Subjects will receive either real or sham stimulation along with cognitive training

--------------- Visit 6 - tDCS + CBCT & Follow-up (3 hours) Subjects will receive either real or sham stimulation along with cognitive training & follow-up neurospychological assessment

--------------- Visit 7 - TMS (3 hours) Subjects will receive TMS in order to induce MEPs

------------ Visit 8 - 2 week follow-up (1 .5 hours) Follow-up neuropsychological assessment

----------- Visit 9 - 2 month follow-up (1.5 hours) Follow-up neuropsycological assessment

Conditions

Normal Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Real tDCS + CBCT

20 minutes of 2.0mA of tDCS for 5 consecutive days

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Computer-based cognitive therapy (CBCT)

Intervention Type: BEHAVIORAL

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

Sham + CBCT

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

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Computer-based cognitive therapy (CBCT)

Intervention Type: BEHAVIORAL

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

Interventions

Transcranial Direct Current Stimulation

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.

Intervention Type: DEVICE

Computer-based cognitive therapy (CBCT)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Normal cognition
• English as their native language

Exclusion Criteria

1. . History of neurological disorders

2. . History of head injury with unconsciousness lasting more than 5 minutes

3. . History of psychiatric disorders

4. . Currently abusing alcohol or drugs (prescription or otherwise)

5. . History of epilepsy or seizures within the past 6 months

6. . Previous brain surgery

7. . Pacemaker

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

822954

Identifier Type: -

Identifier Source: org_study_id