Primary Progressive AphasiaNCT00957710
Language Treatment for Progressive Aphasia
A study testing Errorless learning in people with Primary Progressive Aphasia and Nonfluent Progressive Aphasia, run by Baycrest at 1 site in Canada.
Trial summary
Progressive aphasia is characterized by a steady and progressive loss of language skills in the presence of relatively preserved memory, attention, and thinking. The aim of this study is to slow the progression of language decline in progressive aphasia via language therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia, Nonfluent Progressive Aphasia, Semantic Dementia
- What is being tested?
- Errorless learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Dec 2010
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of progressive aphasia
- Native English speaker or fluent in English
- Adequate hearing and vision (not requiring more than +6 diopter correction)
- Willing and able to participate in each phase of the study (including two fMRI sessions)
Who cannot join
- Contraindications to fMRI (e.g., claustrophobia, pacemaker, ferromagnetic implant)
- Current medical or psychiatric condition affecting cognition (other than progressive aphasia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Slowing Language Decline in Progressive Aphasia Through Language Rehabilitation: Treatment and Neuroimaging Study
Progressive aphasia is characterized by a steady and progressive loss of language skills in the presence of relatively preserved memory, attention, and thinking. The aim of this study is to slow the progression of language decline in progressive aphasia via language therapy. The first goal of this study is to improve naming abilities of individuals with progressive aphasia. This will be accomplished by carrying out an intensive treatment program for anomia. The second goal is to evaluate whether this intense language treatment re-activates affected areas and/or connections within the language network, using functional Magnetic Resonance Imaging (to measure neural activity in specific brain regions) and Diffusion Tensor Imaging tractography (to measure the connectivity between specific brain regions). This is the first study on progressive aphasia addressing both treatment and imaging in the same patients.
- Being tested
- Errorless learning
- Keywords
- progressive aphasia, semantic dementia, neuroimaging, treatment, errorless learning
- Medical subject headings
- Aphasia, Primary Progressive, Primary Progressive Nonfluent Aphasia, Frontotemporal Dementia, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Errorless learningBehavioural
Also called treatment for anomia
Language testing,20 sessions of language therapy, and 2 neuroimaging sessions for participants with progressive aphasia Language testing and 1 imaging session for healthy controls
| Study group | Role | What they receive |
|---|---|---|
| langauge therapy | Other | Naming therapy Receives: Behavioral: Errorless learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of picture naming
Measured: 3 months
Secondary outcomes (1)
Changes on neuroimaging
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Regina Jokel, Baycrest
- Investigators
- Regina Jokel, PhD, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957710
- Sponsor's protocol ID
- REB 09-24
- Status last verified
- Jan 2015
- First submitted
- 11 Aug 2009
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jokel R, Rochon E, Anderson ND. Errorless learning of computer-generated words in a patient with semantic dementia. Neuropsychol Rehabil. 2010 Jan;20(1):16-41. doi: 10.1080/09602010902879859.
PubMed 19504403Jokel R, Rochon E, Leonard C. Treating anomia in semantic dementia: improvement, maintenance, or both? Neuropsychol Rehabil. 2006 Jun;16(3):241-56. doi: 10.1080/09602010500176757.
PubMed 16835150Jokel R, Rochon E, Leonard C. Therapy for anomia in semantic dementia. Brain Cogn. 2002 Jul;49(2):241-4.
PubMed 15259401Jokel R, Cupit J, Rochon E, Leonard C. Relearning lost vocabulary in nonfluent progressive aphasia with Mosstalk Words. Aphasiology 23(2): 175-191, 2009
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slowing Language Decline in Progressive Aphasia Through Language Rehabilitation: Treatment and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT00957710
- Acronym / sponsor ID
- REB 09-24
- Keywords
- progressive aphasia, semantic dementia, neuroimaging, treatment, errorless learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Aug 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.
Progressive aphasia is characterized by a steady and progressive loss of language skills in the presence of relatively preserved memory, attention, and thinking. The aim of this study is to slow the progression of language decline in progressive aphasia via language therapy. The first goal of this study is to improve naming abilities of individuals with progressive aphasia. This will be accomplished by carrying out an intensive treatment program for anomia. The second goal is to evaluate whether this intense language treatment re-activates affected areas and/or connections within the language network, using functional Magnetic Resonance Imaging (to measure neural activity in specific brain regions) and Diffusion Tensor Imaging tractography (to measure the connectivity between specific brain regions). This is the first study on progressive aphasia addressing both treatment and imaging in the same patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| langauge therapy | Other | Behavioral: Errorless learningNaming therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of progressive aphasia
- Native English speaker or fluent in English
- Adequate hearing and vision (not requiring more than +6 diopter correction)
- Willing and able to participate in each phase of the study (including two fMRI sessions)
Key exclusion criteria (2 listed)
- Contraindications to fMRI (e.g., claustrophobia, pacemaker, ferromagnetic implant)
- Current medical or psychiatric condition affecting cognition (other than progressive aphasia)
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 |
|---|---|---|
| Errorless learningAlso: treatment for anomiaLanguage testing,20 sessions of language therapy, and 2 neuroimaging sessions for participants with progressive aphasia Language testing and 1 imaging session for healthy controls | Behavioural | langauge therapy |
Primary outcome
Accuracy of picture naming
Time frame: 3 months
1 secondary outcome
Changes on neuroimaging
Time frame: 3 months
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 27 Jan 2015.
- Background: PubMed 19504403Jokel R, Rochon E, Anderson ND. Errorless learning of computer-generated words in a patient with semantic dementia. Neuropsychol Rehabil. 2010 Jan;20(1):16-41. doi: 10.1080/09602010902879859.
- Background: PubMed 16835150Jokel R, Rochon E, Leonard C. Treating anomia in semantic dementia: improvement, maintenance, or both? Neuropsychol Rehabil. 2006 Jun;16(3):241-56. doi: 10.1080/09602010500176757.
- Background: PubMed 15259401Jokel R, Rochon E, Leonard C. Therapy for anomia in semantic dementia. Brain Cogn. 2002 Jul;49(2):241-4.
- BackgroundJokel R, Cupit J, Rochon E, Leonard C. Relearning lost vocabulary in nonfluent progressive aphasia with Mosstalk Words. Aphasiology 23(2): 175-191, 2009
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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.
Regina Jokel, PhD principal investigator
Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Errorless learning in people with Primary Progressive Aphasia and Nonfluent Progressive Aphasia, run by Baycrest at 1 site in Canada.
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 4 inclusion and 2 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 27 Jan 2015. 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 Canada. 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?
Accuracy of picture naming (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957710, which also lists 4 linked publications.
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 27 Jan 2015.