NCT03034109

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

January 24, 2017

Last Update Submit

October 19, 2017

Conditions

StrokeCognitive DeficitCognitive ImpairmentShort-Term Memory Impairment

Keywords

Transcranial Direct Current StimulationStrokeElectric Stimulation TherapyPrefrontal CortexElectroencephalographyCognitionNeurological RehabilitationMemoryWorking MemoryAttentionConcentrationShort-Term MemoryPlanningExecutive FunctionCerebrovascular disease

Outcome Measures

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.

    before and after each stimulation within 2 hours.

Secondary Outcomes (1)

  • Changes in Auditory Digit Span Test

    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

Study Arms (3)

tDCS conventional stimulation

EXPERIMENTAL

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

High Definition (HD)-tDCS stimulation

EXPERIMENTAL

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 sham stimulation

SHAM COMPARATOR

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

Transcranial Direct Current StimulationDEVICE

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

Also known as: Neuroelectrics Starstim
High Definition (HD)-tDCS stimulationtDCS conventional stimulationtDCS sham stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (3)

  • 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.

    PMID: 17452283BACKGROUND

  • 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.

    PMID: 22037126BACKGROUND

  • 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.

    PMID: 27372845BACKGROUND

MeSH Terms

Conditions

StrokeCognition DisordersCognitive DysfunctionCerebrovascular Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Andrew M Goldfine, MD

    Stony Brook Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 27, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 23, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)