- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611103
Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults
August 31, 2015 updated by: Barry Gordon, M.D., Ph.D., Johns Hopkins University
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities.
In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks.
Our aim is to find out whether tDCS will improve task performance in adults over the age of 55.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants enrolled into this study may be asked to do the following:
- Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable).
- Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
- Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
- Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.
- Participate in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
- The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
Study Type
Interventional
Enrollment (Actual)
43
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 Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Department of Neurology
-
-
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
55 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over the age of 55
- Right Handed
- Native English speaker
Exclusion Criteria:
- History of Seizures
- Any implanted metal device or pacemaker
- Appreciable deficits in hearing or vision
- Greater than 1.5 standard deviations below demographically adjusted means on cognitive screen
- Dementia or Mini Mental Exam below 24
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham Stimulation
transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS
|
delivery of transcranial direct current stimulation or sham stimulation for 20 to 60 minutes
|
|
Experimental: Anodal Stimulation
transcranial direct current stimulation using Anodal stimulation over the area of interest
|
delivery of transcranial direct current stimulation or sham stimulation for 20 to 60 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Test Performance
Time Frame: The average time frame is 2 hours
|
Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests
|
The average time frame is 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barry Gordon, Johns Hopkins University
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
June 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 31, 2012
First Submitted That Met QC Criteria
May 31, 2012
First Posted (Estimate)
June 4, 2012
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 31, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 15657-O
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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