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AphasiaNCT01709383

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

A study testing Transcranial Direct Current Stimulation in people with Aphasia, run by Georgetown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aphasia
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
2 sitesUnited States
Study dates
Dec 2012to Sep 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 11Show fewer
  • Pregnancy
  • Severe comprehension deficits
  • Additional Exclusion Criteria for the optional MRI portion of the study:
  • Presence of metal in the body (except titanium)
  • Claustrophobia

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • MedStar National Rehabilitation Hospital

    Washington D.C., District of Columbia, 20010

  • Georgetown University

    Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Aphasia
Being tested
Transcranial Direct Current Stimulation, Sham Stimulation
Keywords
Aphasia, Stroke, Transcranial Direct Current Stimulation, Neuroplasticity
Medical subject headings
Aphasia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT01709383
Study groupRoleWhat they receive
Transcranial Direct Current StimulationActive comparatorTDCS 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
Receives: Device: Transcranial Direct Current Stimulation
Sham StimulationSham comparatorSham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
Receives: Device: Sham Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline to one day after treatment

Secondary outcomes (6)
  1. 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 (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).

    Measured: Change from baseline to 1 day after treatment

  2. 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. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.

    Measured: 1 day after treatment

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

    Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with "as able as before the stroke" written on the right side of the line and "not at all as able" on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates "as able as before the stroke" and 0 indicates "not at all as able".

    Measured: 3 weeks post-treatment

  4. Cognitive-Linguistic Quick Test (CLQT)

    The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, 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 (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0

    Measured: Change from baseline to 1 day after treatment

  5. Reading Assessments

    A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.

    Measured: Change from baseline to 1 day after treatment

  6. Motricity Index

    An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.

    Measured: Change from baseline to 1 day after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01709383
Sponsor's protocol ID
DDCF 2012062
Status last verified
Oct 2016
First submitted
28 Aug 2012
Last updated
6 Jul 2017
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20040569
  • 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.

    PubMed 21842404
  • 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.

    PubMed 21233468

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Aphasia, run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Aphasia Battery - Revised: Naming and Word Finding Score (time frame: Change from baseline to one day after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01709383, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.

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