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Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits (TDCS-PSMWD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034109
Recruitment Status : Terminated (Negative interim analysis.)
First Posted : January 27, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
National Center for Neuromodulation for Rehabilitation
Information provided by (Responsible Party):
Andrew Goldfine, Stony Brook University

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date October 23, 2017
Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Changes in Cognitive Test Battery [ Time Frame: before and after each stimulation within 2 hours. ]
A series of cognitive tests will be conducted before and after each stimulation. The tests will include a n-back test (0,1,2), a delayed recognition task, and a number capacity task.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Changes in Auditory Digit Span Test [ Time Frame: at baseline, once immediately after stimulation, one time in the evening of the session day and then one more time the day after the session ]
An auditory digit span test (forward and backward) will be asked over phone 4 times.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Official Title  ICMJE Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Brief Summary The purpose of this study is to test the effects of tDCS (Transcranial Direct Current Stimulation) on stroke patients with working memory problems.
Detailed Description

After having a stroke, people often have trouble remembering to do something, solving problems, or following conversations. They can also have trouble concentrating, following instructions, and multitasking. These can all due to the stroke affecting a brain function called "working memory". Working memory is defined as the ability to hold a thought in one's mind for a few seconds in order to remember a task or solve a problem. People have difficulty returning to their normal lives because of these working memory problems. Currently, there no proven medical treatments for working memory problems.

Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has been shown in some studies to improve working memory in healthy subjects. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. TDCS is not an FDA-approved treatment for any condition, but previous trials have shown it may benefit movement and language recovery after stroke, as well as improve thinking ability. Studies have shown tDCS to be very safe with no serious adverse events in over 10,000 subjects studied.

This pilot study will involve four visits to Stony Brook University Hospital. The first is a baseline session where subjects perform all outcome measures but no tDCS is performed other than for familiarization. The other three sessions are the stimulation sessions where subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome measures. The effects of tDCS for a single session are expected to only last for few hours. Subjects will be receiving all three different types of stimulation. If this study finds a short term benefit of tDCS for post-stroke working memory deficits, it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Cognitive Deficit
  • Cognitive Impairment
  • Short-Term Memory Impairment
Intervention  ICMJE Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim
Study Arms  ICMJE
  • Experimental: tDCS conventional stimulation

    Transcranial Direct Current Stimulation:

    The anode will be placed over the left dorsal lateral prefrontal cortex (DLPFC) and the cathode will be placed over the right supraorbital cortex. This is the standard 1 anode by 1 cathodal convention. Stimulation will last 20 minutes.

    Intervention: Device: Transcranial Direct Current Stimulation
  • Experimental: High Definition (HD)-tDCS stimulation

    Transcranial Direct Current Stimulation:

    The anode will be placed over the left DLPFC and 4 cathodes will be placed surrounding the anode. This is the 4 cathode by 1 anode HD-tDCS montage for more focal stimulation. Stimulation will last 20 minutes.

    Intervention: Device: Transcranial Direct Current Stimulation
  • Sham Comparator: tDCS sham stimulation

    Transcranial Direct Current Stimulation:

    The anode will be placed over the left DLPFC and the cathode over the right supraorbital cortex. A short stimulation will be given to the subjects that will mimic the sensation of an actual stimulation but will last much shorter. The session will still last 20 minutes in total to blind both subjects and investigators.

    Intervention: Device: Transcranial Direct Current Stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 19, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
12
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke).
  • Subject reports a decline in attention or short-term memory that began at the time of their stroke.
  • Stroke occurred at least one month prior to first stimulation session.
  • Ability to provide informed consent.
  • Speak English (required for performing the cognitive tests)

Exclusion Criteria:

  • Any other brain disease that can affect cognition (e.g., multiple sclerosis, dementia).
  • Active mental illness such as depression or anxiety
  • Large stroke involving cortex under the stimulation site (using subject provided CT or MRI).
  • Currently taking any drugs that are sodium and/or calcium channel blockers not including amlodipine. This includes some seizure medications along with nicardipine, nifedipine, nimodipine, verapamil and diltiazem.
  • Any history of epilepsy.
  • Subject report of recent drug or alcohol abuse - within the past year.
  • Subject report of pregnant or breastfeeding.
  • Moderate to severe aphasia preventing subject from communicating fully.
  • Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034109
Other Study ID Numbers  ICMJE 986244
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew Goldfine, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE National Center for Neuromodulation for Rehabilitation
Investigators  ICMJE
Principal Investigator: Andrew M Goldfine, MD Stony Brook Medicine
PRS Account Stony Brook University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP