Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

Aphasia Clinical Trial

Official title:

Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709383
• Other study ID #: DDCF 2012062
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2012
• Last updated: December 3, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 MS, 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 SSRI or SNRI 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia

Intervention

Device:
• Transcranial Direct Current Stimulation
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.
• Sham Stimulation
The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Medstar Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 J — View 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. Review. — View 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: 10.1177/1073 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Aphasia Battery - Revised: Naming and Word Finding score	This is a composite measure of verbal expression skills including tests of naming, verbal fluency, and sentence completion.	Change from baseline to one day after treatment	No
Secondary	Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and overall Aphasia Quotient	The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description; a measure of word and sentence repetition; a composite measure of yes/no questions, auditory word recognition, and following sequential commands; and an overall aphasia severity score.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No
Secondary	Philadelphia Naming Test (PNT)	A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No
Secondary	Subjective assessments including: Communicative Effectiveness Index, Stroke and Aphasia Quality of Life Scale, and Stroke Aphasic Depression Questionnaire	A set of questionnaires to be administered to subjects and immediate family members in order to assess the impact of language impairments on functional communication skills and overall quality of life.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No
Secondary	Cognitive-Linguistic Quick Test (CLQT)	The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of attention, executive function, and visuospatial skills.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No
Secondary	Reading assessments	A set of reading tasks designed to assess oral reading of real words and non-words at the single word level.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No
Secondary	Motricity Index	An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction.	Immediately; 2 weeks post-treatment; 12 weeks post-treatment	No