AphasiaNCT00827268
Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
A study testing One-on-one treatment of reading difficulties in people with Aphasia and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Stroke, Dyslexia, Acquired
- What is being tested?
- One-on-one treatment of reading difficulties
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with post-stroke reading difficulties (phonological alexia)
- >3 months post-stroke
- native English speaker
- can go in MRI scanner (3 to 6 scans),
- participate in 90 to 120 free treatment sessions
- return for 3-month post-treatment follow-up assessment \& MRI.
Who cannot join
- mental illness
- degenerative disease, visual or auditory acuity impairment
- drug abuse
- English is not first language
- claustrophobia
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.
Read the detailed description
The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.
- Conditions
- Aphasia, Stroke, Dyslexia, Acquired
- Being tested
- One-on-one treatment of reading difficulties
- Keywords
- Dyslexia, Reading, Aphasia, Stroke
- Medical subject headings
- Aphasia, Stroke, Dyslexia, Acquired, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-on-one treatment of reading difficultiesBehavioural
Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Repeated probes every 8 hours of treatment (1/week) Receives: Behavioral: One-on-one treatment of reading difficulties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Real World Reading Skills
Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised
Measured: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a repeated probe design study.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy W. Conway, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827268
- Sponsor's protocol ID
- B6699-W
- Status last verified
- Nov 2017
- First submitted
- 20 Jan 2009
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
- ClinicalTrials.gov ID
- NCT00827268
- Acronym / sponsor ID
- B6699-W
- Conditions
- Aphasia, Stroke, Dyslexia, Acquired
- Keywords
- Dyslexia, Reading, Aphasia, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Jan 2009 (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.
This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.
Detailed description
The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a repeated probe design study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: One-on-one treatment of reading difficultiesRepeated probes every 8 hours of treatment (1/week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with post-stroke reading difficulties (phonological alexia)
- >3 months post-stroke
- native English speaker
- can go in MRI scanner (3 to 6 scans),
- participate in 90 to 120 free treatment sessions
Key exclusion criteria (6 listed)
- mental illness
- degenerative disease, visual or auditory acuity impairment
- drug abuse
- English is not first language
- claustrophobia
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 |
|---|---|---|
| One-on-one treatment of reading difficultiesMultimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998. | Behavioural | Arm 1 |
Primary outcome
Change in Real World Reading Skills
Time frame: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.
Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised
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 30 Nov 2017.
- Dr. Conway's homepageLink provided by the sponsor.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic 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.
Timothy W. Conway, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-on-one treatment of reading difficulties in people with Aphasia and Stroke, run by VA Office of Research and Development 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 6 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 30 Nov 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. 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 in Real World Reading Skills (time frame: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.). 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 30 Nov 2017.