EMR-Based Treatment for Neurological Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NorthShore University HealthSystem

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by disorder

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to treat common neurological disorders such as epilepsy, migraines, and Parkinson's. Researchers test different treatments to determine which work best for specific conditions, utilizing electronic health records. The focus lies on improving the assignment and tracking of treatments, rather than the treatments themselves. Individuals with conditions like brain tumors, mild cognitive impairment, or multiple sclerosis, who qualify for approved treatments, might be suitable for this study. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiding researchers in understanding its benefits for more patients.

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 is the safety track record for these treatments?

Research shows that the treatments tested for neurological disorders in this trial are generally well-tolerated. These treatments help manage conditions like epilepsy and migraines. Many are already FDA-approved or commonly used for these conditions, indicating prior testing and safety for humans.

While some side effects can occur, studies have shown they are usually mild. For example, migraine medications might cause dizziness or tiredness, but serious issues are rare.

Since these treatments are often used in practice, they are considered safe for most people. Participants in the trial can feel confident about the treatment's safety due to this background. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to manage neurological disorders using electronic medical records (EMR). Unlike standard treatments that focus solely on medication, this approach integrates technology to tailor treatments more precisely to patient needs. This trial aims to demonstrate the feasibility of using EMR for subgroup-based adaptive treatment assignments, electronic consenting, and real-time data capture at the point of care. These advancements could revolutionize how treatments are personalized and managed, potentially improving outcomes across a variety of neurological conditions.

What evidence suggests that this trial's treatments could be effective for neurological disorders?

Research has shown that improving healthcare practices in neurology can enhance patient outcomes and reduce costs. This trial explores the use of electronic medical records (EMR) to customize treatments for conditions such as epilepsy, migraines, and Parkinson’s disease. Participants will be assigned to different treatment arms, each focusing on specific neurological conditions. EMRs provide real-time information and tools to support decision-making. For example, in epilepsy, EMR tools have effectively prevented various types of seizures. In the case of migraines, EMR-based methods have been associated with fewer migraine days and less severe attacks. Overall, this approach aims to use existing approved treatments more effectively by tailoring them to each patient's needs. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with neurological conditions like brain tumors, epilepsy, migraine, cognitive impairments due to mild injury or concussion, multiple sclerosis (MS), neuropathy, Parkinson's disease, restless legs syndrome and stroke. Participants must be eligible for the treatments being tested as per FDA approval or standard off-label use.

Inclusion Criteria

I have been diagnosed with a neurological condition such as MS, Parkinson's, epilepsy, or had a stroke.

I am eligible for treatments approved or used off-label by the FDA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subgroup based adaptive assignment of treatments for neurological disorders using the EMR

Varies by disorder

Follow-up

Participants are monitored for safety and effectiveness after treatment using outcomes data capture at the point of care

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quality Improvement and Practice Based Research

Trial Overview

The study at NorthShore University HealthSystem is testing up to three drugs for each of ten common neurological disorders using electronic medical records (EMR). It aims to find the most effective treatments through adaptive assignment and capture outcomes data directly during patient care.

How Is the Trial Designed?

Group I: Treatment B (see interventions description) Active Control 1 Intervention

The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.

Group II: Treatment A (see interventions description) Active Control 1 Intervention

The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.

Group III: Treatment C (see interventions description) Active Control 1 Intervention

The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.

Who Is Running the Clinical Trial?

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Published Research Related to This Trial

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02670161

Quality Improvement and Practice Based Research in ...

The NorthShore site will share SCDS and CDS tools for 10 common neurological disorders (brain tumors, epilepsy, migraine, mild cognitive impairment, mild ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26576324/

Quality improvement and practice-based research in ...

We describe quality improvement and practice-based research using the electronic medical record (EMR) in a community health system-based department of ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT02670161/quality-improvement-and-practice-based-research-in-neurology-using-the-emr?activelyRecruiting=false&page=460&id=312&slug=dementia

Quality Improvement and Practice Based Research in ...

The NorthShore site will share SCDS and CDS tools for 10 common neurological disorders (brain tumors, epilepsy, migraine, mild cognitive ...

4.

neurology.org

neurology.org/doi/10.1212/WNL.90.15_supplement.S50.001

A Neurology Practice Based Research Network for Quality ...

Quality initiatives improve outcomes and reduce costs. Quality measures have not been systematically incorporated into neurology clinical care.

5.

reporter.nih.gov

reporter.nih.gov/project-details/8938766

Project Details

We will create a national network for quality improvement and practice based patient-centered outcomes research in Neurology using the electronic medical record ...

6.

neurology.org

neurology.org/doi/10.1212/CPJ.0000000000000176

Quality improvement and practice-based research in ...

We present a step-by-step description of our quality journey for 10 neurologic disorders (brain tumors, epilepsy, migraine, memory disorders, ...

7.

researchgate.net

researchgate.net/publication/283277382_Quality_improvement_and_practice-based_research_in_neurology_using_the_electronic_medical_record

(PDF) Quality improvement and practice-based research in ...

We describe quality improvement and practice-based research using the electronic medical record (EMR) in a community health system-based ...