Transcranial Direct Current Stimulation and Aphasia Language Therapy

May 12, 2017 updated by: Leora Cherney, Shirley Ryan AbilityLab
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Anodal stimulation
Device: Transcranial 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.
Other Names:
  • Transcranial direct current stimulation
  • Cortical stimulation
ACTIVE_COMPARATOR: Cathodal stimulation
Device: Transcranial 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.
Other Names:
  • Transcranial direct current stimulation
  • Cortical stimulation
PLACEBO_COMPARATOR: Sham stimulation
Device: Transcranial Direct Current Stimulation - Sham stimulation
Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.
Other Names:
  • No stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aphasia Quotient (AQ) on the Western Aphasia Battery
Time Frame: Change from Baseline in Western Aphasia Battery at 6 weeks
Change from Baseline in Western Aphasia Battery at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Aphasia Battery Aphasia Quotient (Maintenance)
Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Western Aphasia Battery Reading and Writing Scores (Maintenance)
Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Functional communication skills
Time Frame: Change from Baseline in functional communication skills at 6 weeks
Scores derived from language sample analyses
Change from Baseline in functional communication skills at 6 weeks
Participation in everyday activities
Time Frame: Change from Baseline in participation in everyday activities at 6 weeks
Measures on CETI, BOSS, CCRSA
Change from Baseline in participation in everyday activities at 6 weeks
Western Aphasia Battery - Reading and Writing scores
Time Frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Functional Communication Skills (Maintenance)
Time Frame: Communication skills from 6 weeks to 12 weeks
Communication skills from 6 weeks to 12 weeks
Participation in everyday activities (Maintenance)
Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks
Change in participation in everyday activities from 6 weeks to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Leora R Cherney, PhD, Rehabilitation Institute of Chicago, Chicago, IL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (ESTIMATE)

December 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-kaye
  • 1R21DC009876-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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