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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01611103
Other study ID # 15657-O
Secondary ID
Status Completed
Phase N/A
First received May 31, 2012
Last updated August 31, 2015
Start date June 2012
Est. completion date December 2013

Study information

Verified date August 2015
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 79 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
transcranial direct current stimulation
delivery of transcranial direct current stimulation or sham stimulation for 20 to 60 minutes

Locations

Country Name City State
United States Department of Neurology Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive Test Performance 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 No
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