NCT01709383

Brief Summary

This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 6, 2017

Completed
Last Updated

July 6, 2017

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

August 28, 2012

Results QC Date

October 27, 2016

Last Update Submit

June 6, 2017

Conditions

Aphasia

Keywords

AphasiaStrokeTranscranial Direct Current StimulationNeuroplasticity

Outcome Measures

Primary Outcomes (1)

  • Western Aphasia Battery - Revised: Naming and Word Finding Score

    This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.

    Change from baseline to one day after treatment

Secondary Outcomes (6)

  • Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient

    Change from baseline to 1 day after treatment

  • Philadelphia Naming Test (PNT)

    1 day after treatment

  • Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)

    3 weeks post-treatment

  • Cognitive-Linguistic Quick Test (CLQT)

    Change from baseline to 1 day after treatment

  • Reading Assessments

    Change from baseline to 1 day after treatment

  • +1 more secondary outcomes

Study Arms (2)

Transcranial Direct Current Stimulation

ACTIVE COMPARATOR

TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period

Device: Transcranial Direct Current Stimulation

Sham Stimulation

SHAM COMPARATOR

Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Device: Sham Stimulation

Interventions

Transcranial Direct Current StimulationDEVICE

The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Transcranial Direct Current Stimulation
Sham StimulationDEVICE

The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Sham Stimulation

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist

You may not qualify if:

  • Skull defect at or near the site of tDCS delivery
  • History of a significant stroke or traumatic brain injury other than the event that caused the aphasia
  • History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia)
  • Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators)
  • Presence of ferrous metal in the head (e.g. shrapnel)
  • History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants)
  • Pregnancy
  • Severe comprehension deficits
  • Presence of metal in the body (except titanium)
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Related Publications (3)

  • Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29.

    PMID: 20040569RESULT

  • Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.

    PMID: 21842404RESULT

  • Fridriksson J, Richardson JD, Baker JM, Rorden C. Transcranial direct current stimulation improves naming reaction time in fluent aphasia: a double-blind, sham-controlled study. Stroke. 2011 Mar;42(3):819-21. doi: 10.1161/STROKEAHA.110.600288. Epub 2011 Jan 13.

    PMID: 21233468RESULT

MeSH Terms

Conditions

AphasiaStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Elizabeth H. Lacey, PhD, Study Coordinator
Organization
Georgetown University
ehl4@georgetown.edu
202-877-1124

Study Officials

  • Peter Turkeltaub, M.D., Ph.D.

    Georgetown University and MedStar National Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

October 18, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

July 6, 2017

Results First Posted

July 6, 2017

Record last verified: 2016-10

Locations

US(2)