Clinical trial NCT01709383: Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia
Official title: Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: Aphasia
Stroke
Transcranial Direct Current Stimulation
Neuroplasticity
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
First posted: 2012-10-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Additional Exclusion Criteria for the optional MRI portion of the study:

* Presence of metal in the body (except titanium)
* Claustrophobia

Primary outcomes:
measure: Western Aphasia Battery - Revised: Naming and Word Finding Score
timeFrame: Change from baseline to one day after treatment
Secondary outcomes:
measure: Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient
timeFrame: Change from baseline to 1 day after treatment
measure: Philadelphia Naming Test (PNT)
timeFrame: 1 day after treatment
measure: Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)
timeFrame: 3 weeks post-treatment
measure: Cognitive-Linguistic Quick Test (CLQT)
timeFrame: Change from baseline to 1 day after treatment
measure: Reading Assessments
timeFrame: Change from baseline to 1 day after treatment
measure: Motricity Index
timeFrame: Change from baseline to 1 day after treatment
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University and MedStar National Rehabilitation Hospital
name: Peter Turkeltaub, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.