StrokeSTRATEGICNCT03982147
White Matter Connections and Memory: the STRATEGIC Study
An observational study of Stroke and Cognitive Impairment, run by King's College London.
Trial summary
In patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Cognitive Impairment, Memory Impairment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2014to 30 Apr 2022
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recent ischaemic stroke.
Who may be able to join
- Aged over 50 years
- Recent ischaemic stroke
- English is first language
Who cannot join
- Previous large artery infarct
- Major neurological or psychiatric condition
- Moderate to severe head injury (Mayo classification)
- Dementia
- Severe cardiac failure
- Active malignancy
About this study
In patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.
Read the detailed description
Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.
Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.
The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.
- Conditions
- Stroke, Cognitive Impairment, Memory Impairment
- Keywords
- Diffusion tensor imaging
- Medical subject headings
- Stroke, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Patients with recent ischaemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) score at 30-90 days
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.
https://www.mocatest.org
Measured: 30-90 days after stroke
Montreal Cognitive Assessment (MoCA) score at one year
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.
https://www.mocatest.org
Measured: One year after stroke
Montreal Cognitive Assessment (MoCA), change in score over one year
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.
https://www.mocatest.org
Measured: From 30-90 days after stroke to one year after stroke
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Measured: 30-90 days after stroke
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Measured: One year after stroke
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Measured: From 30-90 days after stroke to one year after stroke
Backward digit span score at 30-90 days
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Measured: 30-90 days after stroke.
Backward digit span score at one year
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Measured: One year after stroke
Backward digit span score, change in score over one year
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Measured: From 30-90 days after stroke to one year after stroke
Paired Associate Learning (PAL) recognition score at 30-90 days
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Measured: 30-90 days after stroke.
Paired Associate Learning (PAL) recognition score at one year
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Measured: One year after stroke.
Paired Associate Learning (PAL) recognition score, change in score over one year
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Measured: From 30-90 days after stroke to one year after stroke
Paired Associate Learning (PAL) recall score at 30-90 days
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Measured: 30-90 days after stroke
Paired Associate Learning (PAL) recall score at one year
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Measured: One year after stroke
Paired Associate Learning (PAL) recall score, change in score over one year
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Measured: From 30-90 days after stroke to one year after stroke
Process Dissociation Procedure (PDP) familiarity score at 30-90 days
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: 30-90 days after stroke
Process Dissociation Procedure (PDP) familiarity score at one year
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: One year after stroke
Process Dissociation Procedure (PDP) familiarity score, change in score over one year
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: From 30-90 days after stroke to one year after stroke
Process Dissociation Procedure (PDP) recollection score at 30-90 days
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: 30-90 days after stroke
Process Dissociation Procedure (PDP) recollection score at one year
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: One year after stroke
Process Dissociation Procedure (PDP) recollection score, change in score over one year
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Measured: From 30-90 days after stroke to one year after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start11 Apr 2014
- Primary completion7 Jun 2017
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mike O'Sullivan, King's College London
- Investigators
- Michael J O'Sullivan, MBBS,PhD, Principal investigator, King's College London and University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982147
- Sponsor's protocol ID
- KCH14-072
- Other IDs
- 13/LO/1745, K022113
- Acronym
- STRATEGIC
- Status last verified
- Jun 2019
- First submitted
- 23 Nov 2018
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If possible, we hope to share anonymised test scores and derived MRI measures, along with demographic and other background data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Connections and Memory: the STRATEGIC Study
- ClinicalTrials.gov ID
- NCT03982147
- Acronym / sponsor ID
- STRATEGIC / KCH14-072
- Conditions
- Stroke, Cognitive Impairment, Memory Impairment
- Keywords
- Diffusion tensor imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 11 Apr 2014 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 11 Jun 2019 (actual)
- 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 patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.
Detailed description
Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.
Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.
The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | –Patients with recent ischaemic stroke |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recent ischaemic stroke.
Key inclusion criteria (3 listed)
- Aged over 50 years
- Recent ischaemic stroke
- English is first language
Key exclusion criteria (6 listed)
- Previous large artery infarct
- Major neurological or psychiatric condition
- Moderate to severe head injury (Mayo classification)
- Dementia
- Severe cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Cognitive Assessment (MoCA) score at 30-90 days
Time frame: 30-90 days after stroke
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
Montreal Cognitive Assessment (MoCA) score at one year
Time frame: One year after stroke
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
Montreal Cognitive Assessment (MoCA), change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days
Time frame: 30-90 days after stroke
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year
Time frame: One year after stroke
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., \& Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
Backward digit span score at 30-90 days
Time frame: 30-90 days after stroke.
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Backward digit span score at one year
Time frame: One year after stroke
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Backward digit span score, change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
Paired Associate Learning (PAL) recognition score at 30-90 days
Time frame: 30-90 days after stroke.
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Paired Associate Learning (PAL) recognition score at one year
Time frame: One year after stroke.
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Paired Associate Learning (PAL) recognition score, change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
Paired Associate Learning (PAL) recall score at 30-90 days
Time frame: 30-90 days after stroke
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Paired Associate Learning (PAL) recall score at one year
Time frame: One year after stroke
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Paired Associate Learning (PAL) recall score, change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
Process Dissociation Procedure (PDP) familiarity score at 30-90 days
Time frame: 30-90 days after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Process Dissociation Procedure (PDP) familiarity score at one year
Time frame: One year after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Process Dissociation Procedure (PDP) familiarity score, change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Process Dissociation Procedure (PDP) recollection score at 30-90 days
Time frame: 30-90 days after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Process Dissociation Procedure (PDP) recollection score at one year
Time frame: One year after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Process Dissociation Procedure (PDP) recollection score, change in score over one year
Time frame: From 30-90 days after stroke to one year after stroke
The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: Undecided. If possible, we hope to share anonymised test scores and derived MRI measures, along with demographic and other background data.
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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.
Michael J O'Sullivan, MBBS,PhD principal investigator
King's College London and University of Queensland
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cognitive Impairment, run by King's College London.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Montreal Cognitive Assessment (MoCA) score at 30-90 days (time frame: 30-90 days after stroke). The study lists 21 primary outcomes in all. 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 11 Jun 2019.