CClinicalTrials.gg
TerminatedNCT03034109TDCS-PSMWDUpdated Oct 23, 2017

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

An interventional study of Transcranial Direct Current Stimulation in Stroke, Cognitive Deficit and Cognitive Impairment, sponsored by Stony Brook University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-23.

Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment

Why this study was terminated
Negative interim analysis.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the effects of tDCS (Transcranial Direct Current Stimulation) on stroke patients with working memory problems.

Read the 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.

02

Conditions studied

  • 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
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 5 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceTranscranial Direct Current Stimulation

    TDCS involves sending a weak electrical current to the brain to modulate brain functions.

    Also known as: Neuroelectrics Starstim

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before and after each stimulation within 2 hours.

Secondary outcomes

  1. Changes in Auditory Digit Span Test

    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

07

Study locations

1 site
  • Stony Brook University
    Stony Brook, New York 11794, United States
08

References and documents

Publications

  • 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. PubMed 17452283 ↗
  • 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. PubMed 22037126 ↗
  • 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. PubMed 27372845 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03034109
Lead sponsor
Stony Brook University
Collaborators
National Center of Neuromodulation for Rehabilitation
Responsible party
Andrew Goldfine (Principal Investigator, Stony Brook University) — Principal investigator
First posted
Jan 27, 2017
Start date
Jan 2017
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Oct 23, 2017

Study contacts

Andrew M Goldfine, MD
principal investigator · Stony Brook Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion