Clinical trial NCT03982147: White Matter Connections and Memory: the STRATEGIC Study
Official title: White Matter Connections and Memory: the STRATEGIC Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Cognitive Impairment
Memory Impairment
Keywords: Diffusion tensor imaging
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 193
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recent ischaemic stroke.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA) score at 30-90 days
timeFrame: 30-90 days after stroke
measure: Montreal Cognitive Assessment (MoCA) score at one year
timeFrame: One year after stroke
measure: Montreal Cognitive Assessment (MoCA), change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days
timeFrame: 30-90 days after stroke
measure: Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year
timeFrame: One year after stroke
measure: Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Backward digit span score at 30-90 days
timeFrame: 30-90 days after stroke.
measure: Backward digit span score at one year
timeFrame: One year after stroke
measure: Backward digit span score, change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Paired Associate Learning (PAL) recognition score at 30-90 days
timeFrame: 30-90 days after stroke.
measure: Paired Associate Learning (PAL) recognition score at one year
timeFrame: One year after stroke.
measure: Paired Associate Learning (PAL) recognition score, change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Paired Associate Learning (PAL) recall score at 30-90 days
timeFrame: 30-90 days after stroke
measure: Paired Associate Learning (PAL) recall score at one year
timeFrame: One year after stroke
measure: Paired Associate Learning (PAL) recall score, change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Process Dissociation Procedure (PDP) familiarity score at 30-90 days
timeFrame: 30-90 days after stroke
measure: Process Dissociation Procedure (PDP) familiarity score at one year
timeFrame: One year after stroke
measure: Process Dissociation Procedure (PDP) familiarity score, change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
measure: Process Dissociation Procedure (PDP) recollection score at 30-90 days
timeFrame: 30-90 days after stroke
measure: Process Dissociation Procedure (PDP) recollection score at one year
timeFrame: One year after stroke
measure: Process Dissociation Procedure (PDP) recollection score, change in score over one year
timeFrame: From 30-90 days after stroke to one year after stroke
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King's College London and University of Queensland
name: Michael J O'Sullivan, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References: