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Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults

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ClinicalTrials.gov Identifier: NCT01611103
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Aging Procedure: transcranial direct current stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611103


Locations
United States, Maryland
Department of Neurology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barry Gordon Johns Hopkins University

Responsible Party: Barry Gordon, M.D., Ph.D., Editor-in-Chief, Cognitive and Behavioral Neurology/Therapeutic Cognitive Neuroscience Professor/Professor of Neurology and Cognitive Science, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01611103     History of Changes
Other Study ID Numbers: 15657-O
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Barry Gordon, M.D., Ph.D., Johns Hopkins University:
Cognitive Enhancement
tDCS
stimulation
elderly
older adults