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.
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
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.
- Conditions
- Nonfluent Aphasia, Stroke
- 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 group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Active comparator | Not described Receives: Device: Transcranial Direct Current Stimulation - Anodal stimulation |
| Cathodal stimulation | Active comparator | Not described Receives: Device: Transcranial Direct Current Stimulation - Cathodal stimulation |
| Sham stimulation | Placebo comparator | Not 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.
Aphasia Quotient (AQ) on the Western Aphasia Battery
Measured: Change from Baseline in Western Aphasia Battery at 6 weeks
Secondary outcomes (7)
Functional communication skills
Scores derived from language sample analyses
Measured: Change from Baseline in functional communication skills at 6 weeks
Participation in everyday activities
Measures on CETI, BOSS, CCRSA
Measured: Change from Baseline in participation in everyday activities at 6 weeks
Western Aphasia Battery - Reading and Writing scores
Measured: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Western Aphasia Battery Aphasia Quotient (Maintenance)
Measured: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Western Aphasia Battery Reading and Writing Scores (Maintenance)
Measured: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Functional Communication Skills (Maintenance)
Measured: Communication skills from 6 weeks to 12 weeks
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.
- First posted6 Dec 2011 (estimated)
- Study startMar 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonfluent AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora R Cherney, PhD, Principal investigator, Rehabilitation Institute of Chicago, Chicago, IL
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Aphasia Language Therapy
- ClinicalTrials.gov ID
- NCT01486654
- Acronym / sponsor ID
- 1-kaye
- Conditions
- Nonfluent Aphasia, Stroke
- Keywords
- Cortical stimulation, Ischemic Stroke, Aphasia, Speech and Language Rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal stimulation | Active comparator | Device: Transcranial Direct Current Stimulation - Anodal stimulation |
| Cathodal stimulation | Active comparator | Device: Transcranial Direct Current Stimulation - Cathodal stimulation |
| Sham stimulation | Placebo comparator | Device: Transcranial Direct Current Stimulation - Sham stimulation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation - Cathodal stimulationAlso: Cortical stimulation, Transcranial direct current stimulationCathodal 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. | Device | Cathodal stimulation |
| Transcranial Direct Current Stimulation - Anodal stimulationAlso: Cortical stimulation, Transcranial direct current stimulationAnodal 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. | Device | Anodal stimulation |
| Transcranial Direct Current Stimulation - Sham stimulationAlso: No stimulationSham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks. | Device | Sham stimulation |
Primary outcome
Aphasia Quotient (AQ) on the Western Aphasia Battery
Time frame: Change from Baseline in Western Aphasia Battery at 6 weeks
7 secondary outcomes
Functional communication skills
Time frame: 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
Western Aphasia Battery - Reading and Writing scores
Time frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Western Aphasia Battery Aphasia Quotient (Maintenance)
Time frame: 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
Functional Communication Skills (Maintenance)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Related trials for Nonfluent Aphasia
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
RecruitingObservational study
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
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Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Active, not recruiting
Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia
Aphasia Non Fluent, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leora R Cherney, PhD principal investigator
Rehabilitation Institute of Chicago, Chicago, IL
1 site in 1 country: see every site and its status.
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.