White Matter Connections and Memory: the STRATEGIC Study

Stroke Clinical Trial

— STRATEGIC  

Official title:

White Matter Connections and Memory: the STRATEGIC Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982147
• Other study ID #: KCH14-072
• Secondary ID: 13/LO/1745K02211
• Status: Active, not recruiting
• Start date: April 11, 2014
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 193
• Est. completion date: April 30, 2022
• Est. primary completion date: June 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Aged over 50 years

• Recent ischaemic stroke

• English is first language

Exclusion Criteria:

• Previous large artery infarct

• Major neurological or psychiatric condition

• Moderate to severe head injury (Mayo classification)

• Dementia

• Severe cardiac failure

• Active malignancy

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Memory Impairment
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-90 days after stroke
Primary	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	One year after stroke
Primary	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	From 30-90 days after stroke to one year after stroke
Primary	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.	30-90 days after stroke
Primary	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.	One year after stroke
Primary	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.	From 30-90 days after stroke to one year after stroke
Primary	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.	30-90 days after stroke.
Primary	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.	One year after stroke
Primary	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.	From 30-90 days after stroke to one year after stroke
Primary	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.	30-90 days after stroke.
Primary	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.	One year after stroke.
Primary	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.	From 30-90 days after stroke to one year after stroke
Primary	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).	30-90 days after stroke
Primary	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).	One year after stroke
Primary	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).	From 30-90 days after stroke to one year after stroke
Primary	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.	30-90 days after stroke
Primary	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.	One year after stroke
Primary	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.	From 30-90 days after stroke to one year after stroke
Primary	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.	30-90 days after stroke
Primary	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.	One year after stroke
Primary	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.	From 30-90 days after stroke to one year after stroke

External Links

•   Study information page at King's College London