- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04749719
At Home Brain Stimulation Studies of Memory and Memory Awareness (remTDCS)
July 9, 2021 updated by: Elizabeth Chua, Brooklyn College of the City University of New York
The main goal of this research is to determine the role of several brain regions in memory processes and cognitive functions.
Participants will be remotely supervised via video chat while self-administering tDCS, a form of non-invasive brain stimulation.
Before participating in the experiment, participants will be properly trained on use of the remote tDCS device and screened for eligibility.
While using the tDCS device, participants will be engaging in tasks that assess different aspects of memory and executive functioning.
By using remotely supervised tDCS while participants are completing these cognitive tasks, we will be able to make causal claims about the role of the targeted brain regions in different cognitive processes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ELIZABETH CHUA, PHD
- Phone Number: 6032 7189515000
- Email: echua@brooklyn.cuny.edu
Study Contact Backup
- Name: Casey Imperio, MS
- Phone Number: 6098464723
- Email: cimperio@gradcenter.cuny.edu
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11210
- Recruiting
- Brooklyn College
-
Contact:
- Elizabeth Chua, PhD
- Phone Number: 6032 718-951-5000
- Email: echua@brooklyn.cuny.edu
-
Contact:
- Casey Imperio, MS
- Phone Number: (516) 610-0068
- Email: cimperio@gradcenter.cuny.edu
-
Principal Investigator:
- Elizabeth Chua, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between the ages of 18-35
- normal or corrected to normal vision
- fluent in English and speaking English since age 5
- right handed
Exclusion Criteria:
- chronic skin disease or medical skin condition
- unhealed wound or open skin on the scalp, face, neck, or forehead
- metal or electrode implants (e.g., cochlear implants, pacemakers, metal plates, rods, or screws in their head; for complete detail, see the screening form)
- seizures or a family history of seizures, or are taking medications with a lowered seizure threshold
- pregnant or lactating
- any neurologic or psychiatric diseases
- certain hair styles (dreadlocks, cornrows, etc) or hair coverings (e.g., wigs, hajibs, etc that will not be removed; note that a request can be made for an experimenter of a specific gender)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DLPFC stimulation
F3-SO montage or OLE optimized with 2 mA stimulation for up to 30 min during memory and metamemory task.
|
Low levels of electrical current are applied across the scalp to induce small changes in brain activity.
This is done using remote supervision.
|
|
Sham Comparator: Sham tDCS
F3-SO montage or OLE optimized with sham stimulation for up to 30 min during memory and metamemory task.
|
Low levels of electrical current are applied across the scalp to induce small changes in brain activity.
This is done using remote supervision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory performance
Time Frame: through study completion, an average of 4 weeks
|
% Correct on the Memory Task
|
through study completion, an average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory Confidence
Time Frame: through study completion, an average of 4 weeks
|
Average % Confidence on the Memory Task
|
through study completion, an average of 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metamemory Accuracy
Time Frame: through study completion, an average of 4 weeks
|
Calibration and resolution of confidence and accuracy.
|
through study completion, an average of 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
August 21, 2023
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
February 8, 2021
First Posted (Actual)
February 11, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 42037
- SC3GM121192 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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