Cognitive Outcomes for Stroke

(DISCOVERY Trial)

Recruiting at 31 trial locations

Overseen By James Meschia, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Pre-stroke dementia, Pregnancy, Genetic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

8000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine what affects thinking and memory after a stroke. Researchers seek to identify factors, such as stroke type and existing brain health, that might lead to dementia (serious memory and thinking problems) following a stroke. Participants will contribute by providing blood samples, undergoing brain scans, and completing memory tests. The trial is suitable for individuals who have recently experienced a stroke, such as a blood clot or bleeding in the brain, and can attend an initial visit within six weeks of their stroke. As an unphased study, this trial offers participants the opportunity to contribute to groundbreaking research that could enhance future stroke care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated that collecting blood samples is very safe when done correctly. This involves using the right tools, such as gloves, alcohol wipes, and needles with safety features. Common issues, like bruising or swelling at the draw site, can occur but are usually minor.

Research has shown that brain imaging, such as a brain CT scan, is also safe. It uses a small amount of radiation, which is carefully controlled to minimize risks.

Cognitive assessments, which test memory and thinking, are safe and involve no physical risks. They simply require answering questions or completing tasks on paper or a computer.

Overall, all methods used in this study have been well-tolerated with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could reveal how stroke affects cognition and recovery through various innovative methods. Unlike standard stroke treatments that focus on immediate physical interventions, this trial uses blood sample collection, brain imaging, and cognitive assessments to explore the long-term impacts on brain function. By identifying specific vascular and cognitive outcomes, it could lead to new strategies for improving recovery and quality of life in stroke patients.

What evidence suggests that this trial's treatments could be effective for cognitive outcomes after stroke?

Research shows that the size, type, and location of a stroke greatly affect recovery of thinking and memory skills. Individuals with certain genetic or biological risk factors might experience further declines in brain health after a stroke, impacting cognitive abilities. Brain scans and cognitive tests enable doctors to detect early signs of brain health decline. This detection aids in creating personalized treatment plans to enhance recovery for stroke patients. Although this study does not test a specific treatment, these methods help researchers understand and potentially improve cognitive recovery after a stroke. ^{6 7 8 9 10}

Who Is on the Research Team?

Natalia Rost, MD, MPH

Principal Investigator

Massachusetts General Hospital

Steven Greenberg, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Admitted to the hospital with a diagnosis of acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), or aneurysmal subarachnoid hemorrhage (aSAH)

Radiographic confirmatory evidence of: (1) AIS (based on a focal area of restricted diffusion on MRI), (2) non-traumatic ICH (based on evidence of acute parenchymal hemorrhage CT or brain MRI) or (3) non-traumatic acute aSAH (based on evidence of subarachnoid hemorrhage on CT or MRI and evidence of aneurysm on CT angiography, MR angiography, or conventional catheter-based angiography)

Able to complete baseline visit in person or by phone within 6 weeks of stroke onset

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

1 visit (in-person)

Baseline Assessment

Participants complete a blood draw and a series of cognitive and functional assessments

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for longitudinal cognitive and functional outcomes with in-person and telephone follow-up visits

3-6 months, 18 months, and annual

In-person visits at 3-6 months and 18 months, annual telephone visits

Advanced Imaging and Assessment

Tier 2 participants undergo brain MRI scanning and comprehensive cognitive assessments; Tier 3 participants complete specialized brain imaging (amyloid- and tau-PET/CT scans)

During follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Blood Sample Collection
• Brain Imaging
• Cognitive Assessment

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6200877/

Cognitive effects of stereotactic radiosurgery in adult patients ... Stereotactic radiation surgery (SRS) is increasingly applied in patients with brain metastases (BM) and is expected to have fewer adverse effects on cognitive ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2536637

Effect of Radiosurgery Alone vs Radiosurgery With Whole ... Among patients with 1 to 3 brain metastases, the use of SRS alone, compared with SRS combined with WBRT, resulted in less cognitive deterioration at 3 months.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542166/

Stereotactic Radiosurgery (SRS) and Stereotactic Body ... - NCBI Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06466720

Measuring and Mapping Cognitive Decline After Brain ... In prospective randomised controlled trials, it was shown that Stereotactic Radiosurgery is as effective as whole brain radiotherapy, in terms of local tumour ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405630821000999

Whole Brain Irradiation or Stereotactic RadioSurgery for ... To evaluate neurocognitive performance, daily activity and quality of life (QoL), other than usual oncologic outcomes, among patients with brain metastasis ≥5 ...

6. who.int who.int/publications/i/item/9789241599221

WHO guidelines on drawing blood: best practices in ... The new WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK574569/

Phlebotomy - StatPearls - NCBI Bookshelf The basic tools required for a successful and safe blood draw include a tourniquet, an appropriate needle, gloves, alcohol wipes, and the ...

8. cdc.gov cdc.gov/dpdx/diagnosticprocedures/blood/safety.html

DPDx - Diagnostic Procedures - Blood Specimens Blood Specimens – Safety · Wear personal protective equipment such as safety glasses, gloves, laboratory coats. · If you have cuts or abrasions on the skin of ...

9. elsevier.health elsevier.health/en-US/preview/blood-speciment-venipuncture-syringe

Blood Specimen Collection: Venipuncture Syringe Method ... The use of safer needleless devices, such as those with a reliable integrated safety feature, is recommended. The patient's veins used for venipuncture requires ...

10. ascls.org ascls.org/wp-content/uploads/2012/11/Brochure_Venipuncture_2017.pdf

Blood Specimen Collection (Venipuncture) Previous problems associated with a blood specimen collection (fainting, pain lasting several days, bruising or swelling at the site).