Nonfluent AphasiaPhase 2/3NCT01429077
Augmenting Language Therapy for Aphasia: Levodopa
A Phase 2/3 study testing levodopa/carbidopa 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 the medication levodopa, 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 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?
- levodopa/carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 stroke
- Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient between 20 and 75 on the Western Aphasia Battery
- Age 21 or older.
- At least 6 months post-stroke
- Able to comply with the study protocol
- Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
- Fluent in English premorbidly
- Completed at least 8th grade education
Who cannot join
- More than one stroke
- Any other neurological condition that could potentially affect cognition or speech.
- Global aphasia or inability to participate in routine speech therapy.
- Major active psychiatric illness that may interfere with required study procedures.
- Untreated or inadequately treated depression.
- Has started taking a potentially confounding central nervous system (CNS) drug within the previous 2 months.
Show all 13Show fewer
- Current abuse of alcohol or drugs
- Nursing a child or pregnant
- Participation in another drug, device or biologics trial within the preceding 90 days
- Unable to understand, cooperate or comply with study procedures
- Significant visual or auditory impairment
- History of sensitivity to ergot derivatives.
- Active medical illness or current medication that precludes safe participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Aphasia Research & Treatment
Chicago, Illinois, 60611
About this study
Official title: Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy
The purpose of this study is to evaluate the effectiveness of the medication levodopa, 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.
To enhance motor and language recovery in patients with neurological impairments, interest in the use of novel biological therapies, including pharmacological agents, has recently emerged. There is preliminary evidence that increased levels of dopamine, in combination with language treatment, may improve the deficits of aphasia following stroke. Most studies have investigated the adjunctive effects of the dopamine agonist bromocriptine, with mixed results. However, new evidence is suggesting that levodopa, a precursor to dopamine, may be more effective in promoting language learning.
This study proposes to evaluate the effectiveness of levodopa in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
The language changes in subjects who receive speech and language therapy combined with levodopa will be compared to that of subjects who receive the same speech-language rehabilitation but with a placebo (i.e. a pill that does not contain the study drug, levodopa). The two study groups will be compared to determine the degree to which improvements in language performance occur and the degree to which they are maintained over time.
The protocol is double-blind: neither subjects nor researchers will know whether a subject took levodopa or placebo until the study's conclusion.
- Conditions
- Nonfluent Aphasia, Stroke
- Being tested
- levodopa/carbidopa, Placebo comparator
- Keywords
- Levodopa, Ischemic Stroke, Aphasia, Speech Rehabilitation
- Medical subject headings
- Aphasia, Broca, Stroke, Ischemic Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa/carbidopaDrug
Also called Sinemet
The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
Placebo comparatorDrug
The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Levodopa/carbidopa | Active comparator | The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. Receives: Drug: levodopa/carbidopa |
| Inactive pill | Placebo comparator | The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language Quotient (LQ) on the Western Aphasia Battery
Includes a measure of auditory comprehension, oral expression, reading and written expression skills.
The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement.
Measured: Change from Baseline in Western Aphasia Battery LQ 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, QCL,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: Change in functional 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 posted5 Sep 2011 (estimated)
- Study startOct 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429077
- Sponsor's protocol ID
- H133G070074
- Status last verified
- Nov 2013
- First submitted
- 2 Aug 2011
- Last updated
- 25 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy
- ClinicalTrials.gov ID
- NCT01429077
- Acronym / sponsor ID
- H133G070074
- Conditions
- Nonfluent Aphasia, Stroke
- Keywords
- Levodopa, Ischemic Stroke, Aphasia, Speech Rehabilitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Posted 28 Nov 2013
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 the medication levodopa, 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.
To enhance motor and language recovery in patients with neurological impairments, interest in the use of novel biological therapies, including pharmacological agents, has recently emerged. There is preliminary evidence that increased levels of dopamine, in combination with language treatment, may improve the deficits of aphasia following stroke. Most studies have investigated the adjunctive effects of the dopamine agonist bromocriptine, with mixed results. However, new evidence is suggesting that levodopa, a precursor to dopamine, may be more effective in promoting language learning.
This study proposes to evaluate the effectiveness of levodopa in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
The language changes in subjects who receive speech and language therapy combined with levodopa will be compared to that of subjects who receive the same speech-language rehabilitation but with a placebo (i.e. a pill that does not contain the study drug, levodopa). The two study groups will be compared to determine the degree to which improvements in language performance occur and the degree to which they are maintained over time.
The protocol is double-blind: neither subjects nor researchers will know whether a subject took levodopa or placebo until the study's conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levodopa/carbidopa | Active comparator | Drug: levodopa/carbidopaThe study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. |
| Inactive pill | Placebo comparator | Drug: Placebo comparatorThe placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A single unilateral left-hemisphere stroke
- Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient between 20 and 75 on the Western Aphasia Battery
- Age 21 or older.
- At least 6 months post-stroke
- Able to comply with the study protocol
Key exclusion criteria (13 listed)
- More than one stroke
- Any other neurological condition that could potentially affect cognition or speech.
- Global aphasia or inability to participate in routine speech therapy.
- Major active psychiatric illness that may interfere with required study procedures.
- Untreated or inadequately treated depression.
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 |
|---|---|---|
| levodopa/carbidopaAlso: SinemetThe study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. | Drug | Levodopa/carbidopa |
| Placebo comparatorThe placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. | Drug | Inactive pill |
Primary outcome
Language Quotient (LQ) on the Western Aphasia Battery
Time frame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks
Includes a measure of auditory comprehension, oral expression, reading and written expression skills. The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement.
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: Change in functional 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nonfluent Aphasia
Not yet recruiting
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)
Frontotemporal Lobar Degeneration (FTLD), Progressive Supranuclear Palsy (PSP)
Recruiting
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing levodopa/carbidopa 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 8 inclusion and 13 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 25 Dec 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Language Quotient (LQ) on the Western Aphasia Battery (time frame: Change from Baseline in Western Aphasia Battery LQ 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 25 Dec 2013.