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CompletedNCT01486654Updated May 15, 2017

Transcranial Direct Current Stimulation and Aphasia Language Therapy

A Phase 1 interventional study of Transcranial Direct Current Stimulation - Cathodal stimulation and Transcranial Direct Current Stimulation - Anodal stimulation in Nonfluent Aphasia and Stroke, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-05-15.

Sponsored by Shirley Ryan AbilityLab · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness of small amounts of electrical current, applied without surgery to the brain, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.

Read the detailed description

Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.

A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating and has enormous social and economic impact on quality of life. Presently, the only treatment available for persons with aphasia is speech-language rehabilitation.

With rehabilitation only, however, many patients achieve a less than satisfactory improvement in speech-language function, and thus are left with significant disability.

Enhancing stroke recovery by facilitating brain plasticity with the direct application of stimulation to the cerebral cortex is a new area of investigation and shows promise for improving language recovery in stroke-induced aphasia, most probably when it is combined with intense learning. There are several methods of delivering cortical brain stimulation to modulate cortical excitability, each of which have been studied in animal models with promising results, and subsequently applied to the rehabilitation of motor deficits after stroke. Applications to language problems after stroke are only emerging. Nevertheless, results suggest a potential role for cortical stimulation as an adjuvant strategy in aphasia rehabilitation.

Of the cortical stimulation methods available, transcranial direct current stimulation (tDCS) has the greatest potential for clinical use in view of its non-invasive application, ease of administration and relatively low cost. tDCS is a method of delivering weak polarizing electrical currents to the cortex via two electrodes placed on the scalp. The nature of the effect depends on the polarity of the current. Anodal tDCS has an excitatory effect; cathodal tDCS induces inhibition.

This study proposes to evaluate the safety, feasibility, and effectiveness of anodal and cathodal tDCS in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.

Subjects will receive speech and language therapy combined with either anodal, cathodal, or sham stimulation applied to the lesioned left hemisphere. The polarity conditions will be compared with each other and with sham stimulation, to determine safety, the degree to which improvements in language performance occur, and the degree to which they are maintained over time.

The protocol is single-blind. Neither the subjects nor the outcomes assessor will know what stimulation the subject received until the study's conclusion; the investigator applying the stimulation will know.

02

Conditions studied

  • Nonfluent Aphasia
  • Stroke

Keywords

  • Cortical stimulation
  • Ischemic Stroke
  • Aphasia
  • Speech and Language Rehabilitation
03

In context

Aphasia, Broca

43 studies on the registry are indexed under Aphasia, Broca; 13 are open to participants now.

This study's planned enrollment of 12 is below the median of 30 across 39 interventional studies indexed under Aphasia, Broca.

Browse Aphasia, Broca studies →

Lead sponsor

Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A single unilateral left-hemisphere infarct that is confirmed by CT scan or MRI
  • Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient score on the Western Aphasia Battery of 25-70
  • Age 21 or older
  • At least 6 months post-stroke
  • Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
  • Premorbidly literate in English
  • Completed at least an eighth grade education
  • Visual acuity no worse than 20/100 corrected in the better eye
  • Auditory acuity, aided in the better ear, no worse than 30 dB HL on a pure tone hearing screening (conducted at 500, 1000, 2000, and 4000 Hz.)

Exclusion criteria

Exclusion Criteria:

  • Any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury
  • Any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered
  • Active substance abuse
  • Seizure disorder that precludes safe participation in this trial
  • Absence of left hemisphere activation during two of the three fMRI tasks
  • Presence of lesions that encompass premotor cortex from the Sylvian fissure to a point high on the convexity
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    Anodal stimulation

    Device: Transcranial Direct Current Stimulation - Anodal stimulation

  • Active comparator
    Cathodal stimulation

    Device: Transcranial Direct Current Stimulation - Cathodal stimulation

  • Placebo comparator
    Sham stimulation

    Device: Transcranial Direct Current Stimulation - Sham stimulation

Interventions

  • DeviceTranscranial Direct Current Stimulation - Cathodal stimulation

    Cathodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.

    Also known as: Cortical stimulation, Transcranial direct current stimulation

  • DeviceTranscranial Direct Current Stimulation - Anodal stimulation

    Anodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.

    Also known as: Cortical stimulation, Transcranial direct current stimulation

  • DeviceTranscranial Direct Current Stimulation - Sham stimulation

    Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.

    Also known as: No stimulation

06

What researchers measure

Primary outcomes

  1. Aphasia Quotient (AQ) on the Western Aphasia Battery

    Time frame: Change from Baseline in Western Aphasia Battery at 6 weeks

Secondary outcomes

  1. Functional communication skills

    Scores derived from language sample analyses

    Time frame: Change from Baseline in functional communication skills at 6 weeks

  2. Participation in everyday activities

    Measures on CETI, BOSS, CCRSA

    Time frame: Change from Baseline in participation in everyday activities at 6 weeks

  3. Western Aphasia Battery - Reading and Writing scores

    Time frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks

  4. Western Aphasia Battery Aphasia Quotient (Maintenance)

    Time frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks

  5. Western Aphasia Battery Reading and Writing Scores (Maintenance)

    Time frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks

  6. Functional Communication Skills (Maintenance)

    Time frame: Communication skills from 6 weeks to 12 weeks

  7. Participation in everyday activities (Maintenance)

    Time frame: Change in participation in everyday activities from 6 weeks to 12 weeks

07

Study locations

1 site
  • Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
    Chicago, Illinois 60611, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2010, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2011
First posted
Dec 6, 2011
Start
Mar 2010
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
May 15, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01486654
Responsible party
Leora Cherney (Principal Investigator, Shirley Ryan AbilityLab) — Principal investigator
First posted
Dec 6, 2011
Start date
Mar 2010
Primary completion
Dec 2016
Completion
Dec 2016
Last update
May 15, 2017

Study contacts

Leora R Cherney, PhD
principal investigator · Rehabilitation Institute of Chicago, Chicago, IL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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