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

Primary Purpose

Stroke, Cognitive Deficit, Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stony Brook University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tDCS conventional stimulation

High Definition (HD)-tDCS stimulation

tDCS sham stimulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in Cognitive Test Battery
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

Changes in Auditory Digit Span Test
An auditory digit span test (forward and backward) will be asked over phone 4 times.

Full Information

First Posted
January 24, 2017
Last Updated
October 19, 2017
Sponsor
Stony Brook University
Collaborators
National Center of Neuromodulation for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT03034109
Brief Title
Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Acronym
TDCS-PSMWD
Official Title
Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Negative interim analysis.
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
National Center of Neuromodulation for Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Deficit, Cognitive Impairment, Short-Term Memory Impairment
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS conventional stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
High Definition (HD)-tDCS stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS sham stimulation
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Neuroelectrics Starstim
Intervention Description
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Primary Outcome Measure Information:
Title
Changes in Cognitive Test Battery
Description
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.
Time Frame
before and after each stimulation within 2 hours.
Secondary Outcome Measure Information:
Title
Changes in Auditory Digit Span Test
Description
An auditory digit span test (forward and backward) will be asked over phone 4 times.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Goldfine, MD
Organizational Affiliation
Stony Brook Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17452283
Citation
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Results Reference
background
PubMed Identifier
22037126
Citation
Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
Results Reference
background
PubMed Identifier
27372845
Citation
Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
Results Reference
background

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

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