Transcranial Direct Current Stimulation and Aphasia Language Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01486654
First received: December 2, 2011
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Nonfluent Aphasia
Stroke
Device: Transcranial Direct Current Stimulation - Cathodal stimulation
Device: Transcranial Direct Current Stimulation - Anodal stimulation
Device: Transcranial Direct Current Stimulation - Sham stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation and Aphasia Language Therapy

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Aphasia Quotient (AQ) on the Western Aphasia Battery [ Time Frame: Change from Baseline in Western Aphasia Battery at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional communication skills [ Time Frame: Change from Baseline in functional communication skills at 6 weeks ] [ Designated as safety issue: No ]
    Scores derived from language sample analyses

  • Participation in everyday activities [ Time Frame: Change from Baseline in participation in everyday activities at 6 weeks ] [ Designated as safety issue: No ]
    Measures on CETI, BOSS, CCRSA

  • Western Aphasia Battery - Reading and Writing scores [ Time Frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks ] [ Designated as safety issue: No ]
  • Western Aphasia Battery Aphasia Quotient (Maintenance) [ Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Western Aphasia Battery Reading and Writing Scores (Maintenance) [ Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Functional Communication Skills (Maintenance) [ Time Frame: Communication skills from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Participation in everyday activities (Maintenance) [ Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Cortical stimulation
  • Transcranial direct current 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:
  • Cortical stimulation
  • Transcranial direct current 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 Name: No stimulation

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486654

Locations
United States, Illinois
Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Leora R Cherney, PhD Rehabilitation Institute of Chicago, Chicago, IL
  More Information

No publications provided

Responsible Party: Leora Cherney, Principal Investigator, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01486654     History of Changes
Other Study ID Numbers: 1-kaye, 1R21DC009876-01A1
Study First Received: December 2, 2011
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Cortical stimulation
Ischemic Stroke
Aphasia
Speech and Language Rehabilitation

Additional relevant MeSH terms:
Aphasia
Aphasia, Broca
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014