Stroke-induced AphasiaNCT02012374
Overcoming Learned Non-Use in Chronic Aphasia
A study testing Intensive Language Action Therapy in people with Stroke-induced Aphasia, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
In this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke-induced Aphasia
- What is being tested?
- Intensive Language Action Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2012to 9 Jul 2015
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral left hemisphere stroke at least 6 months earlier
- aphasia with moderate-to-severe word retrieval impairments
- at least 21 years of age
- premorbidly right handed
- native speaker of English
Who cannot join
- history of developmental learning difficulties
- history of prior neurological illnesses
- chronic medical illnesses that restrict participation in intensive therapy
- recent alcohol or drug dependence
- severe uncorrected impairments of vision or hearing
- any contraindication to a 3T MRI procedure (e.g., claustrophobia, metal implants or fragments in body, pregnancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
Official title: Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes
In this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. Both treatments involve massed practice communicating, using intensive language action therapy 3 hours/day, 5 days/week for two weeks, followed by six months of a home practice program. One treatment stresses spoken responses as the preferred expressive modality during intensive therapy. Before and after treatment, and following the home practice program and a period of no practice, the investigators will administer several tests and discourse samples to examine changes associated with the treatments. Participants will also undergo structural and functional MRI testing at these time points. The investigators will also attempt to quantify the degree to which improvements following intensive language therapy and home practice correlate with changes in Quality of Life measures as perceived by both participants with aphasia and their significant others. It is hypothesized that, whereas both treatments will lead to improvements in naming practiced words and communicating, outcomes will be enhanced for the group randomly assigned to the "constraint" condition. Moreover, performance will be enhanced on words practiced during the home practice program, including those that were not practiced during intensive therapy. Improved naming will correlate with modulation of 'signature' language and attentional networks, whose variability will depend on remaining viable brain structures. Initial severity and site/extent of lesion should predict patients' ability to transfer gains in naming to improvements in discourse.
- Conditions
- Stroke-induced Aphasia
- Being tested
- Intensive Language Action Therapy
- Keywords
- aphasia, anomia, speech therapy, rehabilitation, neuroplasticity, fMRI, quality of life
- Medical subject headings
- Aphasia, Anomia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Language Action TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intensive Language Action Therapy ("constrained") | Experimental | Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. Spoken responses are explicitly modeled and encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment. Receives: Behavioral: Intensive Language Action Therapy |
| Unconstrained Intensive Language Action Therapy | Experimental | Following a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. All communicative responses are encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment. Receives: Behavioral: Intensive Language Action Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change from baseline on Confrontation Naming Task
Measured: Change will be assessed immediately post-treatment (2 weeks)
Secondary outcomes (1)
Change from baseline Boston Diagnostic Aphasia Examination
Measured: Change will be assessed immediately post-treatment (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study start26 Feb 2012
- Primary completion17 Mar 2015
- Study completion9 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke-induced 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Jacquie Kurland, Ph.D., Principal investigator, UMass Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012374
- Sponsor's protocol ID
- 2011-1065
- Status last verified
- Dec 2022
- First submitted
- 12 Feb 2013
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes
- ClinicalTrials.gov ID
- NCT02012374
- Acronym / sponsor ID
- 2011-1065
- Conditions
- Stroke-induced Aphasia
- Keywords
- aphasia, anomia, speech therapy, rehabilitation, neuroplasticity, fMRI, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 26 Feb 2012 (actual)
- Primary completion
- 17 Mar 2015 (actual)
- Study completion
- 9 Jul 2015 (actual)
- First posted
- 16 Dec 2013 (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.
In this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. Both treatments involve massed practice communicating, using intensive language action therapy 3 hours/day, 5 days/week for two weeks, followed by six months of a home practice program. One treatment stresses spoken responses as the preferred expressive modality during intensive therapy. Before and after treatment, and following the home practice program and a period of no practice, the investigators will administer several tests and discourse samples to examine changes associated with the treatments. Participants will also undergo structural and functional MRI testing at these time points. The investigators will also attempt to quantify the degree to which improvements following intensive language therapy and home practice correlate with changes in Quality of Life measures as perceived by both participants with aphasia and their significant others. It is hypothesized that, whereas both treatments will lead to improvements in naming practiced words and communicating, outcomes will be enhanced for the group randomly assigned to the "constraint" condition. Moreover, performance will be enhanced on words practiced during the home practice program, including those that were not practiced during intensive therapy. Improved naming will correlate with modulation of 'signature' language and attentional networks, whose variability will depend on remaining viable brain structures. Initial severity and site/extent of lesion should predict patients' ability to transfer gains in naming to improvements in discourse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Language Action Therapy ("constrained") | Experimental | Behavioral: Intensive Language Action TherapyFollowing a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. Spoken responses are explicitly modeled and encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment. |
| Unconstrained Intensive Language Action Therapy | Experimental | Behavioral: Intensive Language Action TherapyFollowing a phase of baseline pre-treatment testing, speech therapy sessions take place 5 days/week for 3 hours per session during two consecutive weeks. All communicative responses are encouraged during therapy. Following the intensive 2-week treatment, participants are trained in using individualized home practice programs on iPads. They practice approximately daily for six months, checking in weekly with an SLP via videoconferencing software and return for probes monthly. Six months post-treatment testing will take place following completion of the home practice phase and again at 12 months post-treatment. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral left hemisphere stroke at least 6 months earlier
- aphasia with moderate-to-severe word retrieval impairments
- at least 21 years of age
- premorbidly right handed
- native speaker of English
Key exclusion criteria (6 listed)
- history of developmental learning difficulties
- history of prior neurological illnesses
- chronic medical illnesses that restrict participation in intensive therapy
- recent alcohol or drug dependence
- severe uncorrected impairments of vision or hearing
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 |
|---|---|---|
| Intensive Language Action Therapy | Behavioural | Intensive Language Action Therapy ("constrained"), Unconstrained Intensive Language Action Therapy |
Primary outcome
• Change from baseline on Confrontation Naming Task
Time frame: Change will be assessed immediately post-treatment (2 weeks)
1 secondary outcome
Change from baseline Boston Diagnostic Aphasia Examination
Time frame: Change will be assessed immediately post-treatment (2 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 20 Dec 2022.
Related trials for Stroke-induced Aphasia
Not yet recruiting
Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
Non-fluent Aphasia
RecruitingPhase 2
Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia
Aphasia, 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.
Jacquie Kurland, Ph.D. principal investigator
UMass Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Language Action Therapy in people with Stroke-induced Aphasia, run by University of Massachusetts, Amherst 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 5 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 20 Dec 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
• Change from baseline on Confrontation Naming Task (time frame: Change will be assessed immediately post-treatment (2 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 20 Dec 2022.