Transcranial Direct Current Stimulation and Aphasia Language Therapy
Primary Purpose
Nonfluent Aphasia, Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation - Cathodal stimulation
Transcranial Direct Current Stimulation - Anodal stimulation
Transcranial Direct Current Stimulation - Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Nonfluent Aphasia focused on measuring Cortical stimulation, Ischemic Stroke, Aphasia, Speech and Language Rehabilitation
Eligibility 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
Sites / Locations
- Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Anodal stimulation
Cathodal stimulation
Sham stimulation
Arm Description
Outcomes
Primary Outcome Measures
Aphasia Quotient (AQ) on the Western Aphasia Battery
Secondary Outcome Measures
Functional communication skills
Scores derived from language sample analyses
Participation in everyday activities
Measures on CETI, BOSS, CCRSA
Western Aphasia Battery - Reading and Writing scores
Western Aphasia Battery Aphasia Quotient (Maintenance)
Western Aphasia Battery Reading and Writing Scores (Maintenance)
Functional Communication Skills (Maintenance)
Participation in everyday activities (Maintenance)
Full Information
NCT ID
NCT01486654
First Posted
December 2, 2011
Last Updated
May 12, 2017
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT01486654
Brief Title
Transcranial Direct Current Stimulation and Aphasia Language Therapy
Official Title
Transcranial Direct Current Stimulation and Aphasia Language Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonfluent Aphasia, Stroke
Keywords
Cortical stimulation, Ischemic Stroke, Aphasia, Speech and Language Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anodal stimulation
Arm Type
Active Comparator
Arm Title
Cathodal stimulation
Arm Type
Active Comparator
Arm Title
Sham stimulation
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation - Cathodal stimulation
Other Intervention Name(s)
Cortical stimulation, Transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation - Anodal stimulation
Other Intervention Name(s)
Cortical stimulation, Transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation - Sham stimulation
Other Intervention Name(s)
No stimulation
Intervention Description
Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.
Primary Outcome Measure Information:
Title
Aphasia Quotient (AQ) on the Western Aphasia Battery
Time Frame
Change from Baseline in Western Aphasia Battery at 6 weeks
Secondary Outcome Measure Information:
Title
Functional communication skills
Description
Scores derived from language sample analyses
Time Frame
Change from Baseline in functional communication skills at 6 weeks
Title
Participation in everyday activities
Description
Measures on CETI, BOSS, CCRSA
Time Frame
Change from Baseline in participation in everyday activities at 6 weeks
Title
Western Aphasia Battery - Reading and Writing scores
Time Frame
Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Title
Western Aphasia Battery Aphasia Quotient (Maintenance)
Time Frame
Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Title
Western Aphasia Battery Reading and Writing Scores (Maintenance)
Time Frame
Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Title
Functional Communication Skills (Maintenance)
Time Frame
Communication skills from 6 weeks to 12 weeks
Title
Participation in everyday activities (Maintenance)
Time Frame
Change in participation in everyday activities from 6 weeks to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora R Cherney, PhD
Organizational Affiliation
Rehabilitation Institute of Chicago, Chicago, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
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Transcranial Direct Current Stimulation and Aphasia Language Therapy
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