Early Neuroimaging for Stroke Recovery

(MECHANIST Trial)

Recruiting at 2 trial locations

Overseen By Bradley R Holubar, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Premorbid disability, Sensorimotor impairment, others

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

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how stroke affects movement and recovery, with a focus on arm and hand movement issues. Researchers will examine brain images and conduct movement tests over time to identify early signs that predict these movement problems. Individuals who have experienced a stroke affecting specific brain areas and have movement issues, but no major speech or vision problems, might be suitable candidates. The knowledge gained could enhance predictions and treatments for stroke recovery, specifically targeting motor recovery with early imaging.

As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could improve future stroke recovery treatments.

Will I have to stop taking my current medications?

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.

What prior data suggests that this neuroimaging protocol is safe for stroke patients?

Research has shown that early imaging to aid movement recovery after a stroke is generally safe. Most patients improve in the weeks or months following a stroke, though many still face some challenges. Treatments focusing on movement recovery, such as specific motor tests, have been well-received by patients.

Some studies have examined the effects of starting rehabilitation soon after a stroke, but results are mixed. One review found that beginning rehab very early might increase the risk of death or severe stroke while in the hospital. However, it also suggested that early rehab could help reduce long-term disability.

Overall, the treatment in this trial emphasizes imaging and motor testing, which are generally safe. However, any early treatment might carry some risks. Patients should discuss potential benefits and risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Motor Recovery with Early Imaging in Stroke approach because it aims to enhance stroke recovery by using advanced imaging techniques early in the treatment process. Unlike traditional stroke treatments that primarily focus on physical rehabilitation and medication after the fact, this method uses imaging to tailor interventions specific to the patient's brain injury right away. By identifying the precise areas of damage early, doctors can optimize recovery strategies, potentially improving outcomes and speeding up recovery times. This personalized approach could represent a significant shift in how stroke recovery is managed, offering hope for more effective treatments.

What evidence suggests that early neuroimaging is effective for stroke recovery?

Research has shown that early brain scans can predict which stroke patients will regain movement. These scans identify patients likely to recover. Studies have also found that adding motor imagery (thinking about moving) to regular therapy can enhance recovery. Approximately 60% of patients can fully recover hand function within six months if they show early improvement. Starting rehabilitation soon after a stroke is crucial for better results. ^{6 7 8 9 10}

Who Is on the Research Team?

Julius PA Dewald, PT, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Inclusion Criteria

Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission

Isolated motor deficits (hemiparesis) without significant aphasia, visual disturbances, or neglect based on the following scores on the NIH Stroke Scale: 1a (level of consciousness) = 0- Alert; keenly responsive. 1b (LOC questions) = 0- Asked month and age; Answers both correctly. 1c (LOC commands) = 0- Asked to open/close eyes, grasp/release hand; Performs both correctly. 2 (Best Gaze) = 0- Horizontal eye movements; Normal. 5 (Motor Arm) = 1, 2, 3, or 4- Arm placed at 90 (sitting) or 45 (supine), Drift, Some effort, No effort against gravity, or No movement. 7 (Limb Ataxia) = 0- Finger-nose-finger or heel-shin test; Absent. 8 (Sensory) = 0 or 1- Pin prick; Normal or Mild-to-moderate sensory loss. 9 (Best Language) = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia. 11 (Extinction and Inattention) = 0 or 1- No abnormality or Inattention to one modality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Assessment

Neuroimaging and quantitative motor testing conducted within 96 hours post-stroke

1 week

1 visit (in-person)

Early Follow-up

Neuroimaging and quantitative motor testing conducted 2 weeks post-stroke

2 weeks

1 visit (in-person)

Mid-term Follow-up

Neuroimaging and quantitative motor testing conducted 3 months post-stroke

3 months

1 visit (in-person)

Long-term Follow-up

Neuroimaging and quantitative motor testing conducted 6 months post-stroke

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Motor Recovery with Early Imaging in Stroke

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2279137/

Efficacy of motor imagery in post-stroke rehabilitation Current evidence suggests that Motor imagery provides additional benefits to conventional physiotherapy or occupational therapy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213158224000755

Neuroimaging of motor recovery after ischemic stroke Post-stroke motor recovery can be predicted by early neuroimaging measures. Abstract. The long-term motor outcome of acute stroke patients may be correlated to ...

3. emedicine.medscape.com emedicine.medscape.com/article/324386-overview

Motor Recovery In Stroke Full recovery at 6 months was achieved in 60% of patients with some early finger extension. Recovery of function in the LEs. Recovery of LE ...

4. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.113.000968

Rehabilitation is Initiated Early After Stroke, but Most Motor ... The aim of this review was to determine the percentage of motor rehabilitation RCTs initiated within 30 days of stroke, and characterize these studies.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1402729/full

Stroke rehabilitation: from diagnosis to therapy This paper provides a thorough exploration of rehabilitation strategies in stroke management, focusing on diagnostic methods, acute management, and diverse ...

6. trialx.com trialx.com/clinical-trials/listings/231033/motor-recovery-with-early-imaging-in-stroke/

Motor rECovery witH eArly imagiNg In STroke The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3593410/

Imaging motor recovery after stroke - PMC - PubMed Central Most patients show improvement in the weeks or months after a stroke. Recovery is incomplete, however, leaving most with significant impairment and disability.

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043159

Evidence of rTMS for Motor or Cognitive Stroke Recovery This systematic review and meta-analysis of 57 articles involving 2595 subjects show that divergent rTMS techniques are safe and hold potential ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1423517/full

Efficacy and safety of very early rehabilitation for acute ... This meta-analysis proved that VER could elevate the risk of death after stroke and stroke severity during hospitalization. However, it significantly lowered ...

10. neurolrespract.biomedcentral.com neurolrespract.biomedcentral.com/articles/10.1186/s42466-020-00060-6

Recovery from stroke: current concepts and future perspectives This review provides a comprehensive survey of recent developments in the field of stroke recovery using neuroimaging and non-invasive brain stimulation.