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

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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

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.

Condition or disease Intervention/treatment Phase
Stroke Cognitive Deficit Cognitive Impairment Short-Term Memory Impairment Device: Transcranial Direct Current Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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.

Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim

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.

Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim

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.

Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03034109


Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
National Center for Neuromodulation for Rehabilitation
Investigators
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Principal Investigator: Andrew M Goldfine, MD Stony Brook Medicine

Publications:
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Responsible Party: Andrew Goldfine, Principal Investigator, Stony Brook University
ClinicalTrials.gov Identifier: NCT03034109     History of Changes
Other Study ID Numbers: 986244
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrew Goldfine, Stony Brook University:
Transcranial Direct Current Stimulation
Stroke
Electric Stimulation Therapy
Prefrontal Cortex
Electroencephalography
Cognition
Neurological Rehabilitation
Memory
Working Memory
Attention
Concentration
Short-Term Memory
Planning
Executive Function
Cerebrovascular disease

Additional relevant MeSH terms:
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Stroke
Cognitive Dysfunction
Cognition Disorders
Memory Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms