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Nonfluent AphasiaPhase 1NCT01486654

Transcranial Direct Current Stimulation and Aphasia Language Therapy

A Phase 1 study testing Transcranial Direct Current Stimulation - Cathodal stimulation and Transcranial Direct Current Stimulation - Anodal stimulation in people with Nonfluent Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site 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

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Nonfluent Aphasia, Stroke
What is being tested?
Transcranial Direct Current Stimulation - Cathodal stimulation and Transcranial Direct Current Stimulation - Anodal stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
Mar 2010to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

Other trials in United States

About this study

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.

Being tested
Transcranial Direct Current Stimulation - Cathodal stimulation, Transcranial Direct Current Stimulation - Anodal stimulation, Transcranial Direct Current Stimulation - Sham stimulation
Keywords
Cortical stimulation, Ischemic Stroke, Aphasia, Speech and Language Rehabilitation
Medical subject headings
Aphasia, Broca, Stroke, Ischemic Stroke, Aphasia, Speech

What participants receive

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

  • Transcranial Direct Current Stimulation - Cathodal stimulationDevice

    Also called Cortical stimulation, Transcranial direct current 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.

  • Transcranial Direct Current Stimulation - Anodal stimulationDevice

    Also called Cortical stimulation, Transcranial direct current 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.

  • Transcranial Direct Current Stimulation - Sham stimulationDevice

    Also called No stimulation

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

Study groups in NCT01486654
Study groupRoleWhat they receive
Anodal stimulationActive comparatorNot described
Receives: Device: Transcranial Direct Current Stimulation - Anodal stimulation
Cathodal stimulationActive comparatorNot described
Receives: Device: Transcranial Direct Current Stimulation - Cathodal stimulation
Sham stimulationPlacebo comparatorNot described
Receives: Device: Transcranial Direct Current Stimulation - Sham stimulation

What is being measured

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

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

    Measured: Change from Baseline in Western Aphasia Battery at 6 weeks

Secondary outcomes (7)
  1. Functional communication skills

    Scores derived from language sample analyses

    Measured: Change from Baseline in functional communication skills at 6 weeks

  2. Participation in everyday activities

    Measures on CETI, BOSS, CCRSA

    Measured: Change from Baseline in participation in everyday activities at 6 weeks

  3. Western Aphasia Battery - Reading and Writing scores

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

  4. Western Aphasia Battery Aphasia Quotient (Maintenance)

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

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

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

  6. Functional Communication Skills (Maintenance)

    Measured: Communication skills from 6 weeks to 12 weeks

  7. Participation in everyday activities (Maintenance)

    Measured: Change in participation in everyday activities from 6 weeks to 12 weeks

Timeline

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

  1. First posted6 Dec 2011 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486654
Sponsor's protocol ID
1-kaye
Other IDs
1R21DC009876-01A1
Status last verified
May 2017
First submitted
2 Dec 2011
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Transcranial Direct Current Stimulation - Cathodal stimulation and Transcranial Direct Current Stimulation - Anodal stimulation in people with Nonfluent Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site 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 9 inclusion and 6 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Aphasia Quotient (AQ) on the Western Aphasia Battery (time frame: Change from Baseline in Western Aphasia Battery at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 May 2017.

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