- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050046
Noninvasive Brain Stimulation to Enhance Cognitive Training in Older Adults (MINDS)
Noninvasive Brain Stimulation to Enhance Cognitive Training and Assess Neuroplasticity in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Normal cognition
- English as their native language
Exclusion Criteria:
- . 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Real tDCS + CBCT
20 minutes of 2.0mA of tDCS for 5 consecutive days
|
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.
Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct.
|
Sham Comparator: Sham + CBCT
Sham stimulation closely imitates reals tDCS 30 second ramp-up / ramp-down
|
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.
Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive Function
Time Frame: baseline, day 5, 2 week, 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TMS brain activation
Time Frame: 2 week
|
Change in average amplitude of MEPs as a response to TMS.
We expect to see an initial reduction (or inhibition) in average amplitude of the MEP response to TMS, followed by a return to baseline amplitude.
|
2 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 822954
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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