Quality Improvement and Practice Based Research in Neurology Using the EMR

NCT02670161 | Enrolling By Invitation Phase 4

• 2 other identifiers: EH14-3551R01HS024057-01
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct at NorthShore University HealthSystem pragmatic trials using the EMR for 10 common neurological disorders. They will demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data capture at the point of care using the EMR. They will identify the most effective treatments for common neurological disorders and seek replication by the NPBRN.

Conditions

Brain Tumors; Epilepsy; Migraine; Mild Cognitive Impairment; Concussion; Multiple Sclerosis; Neuropathy; Parkinson's; Restless Legs Syndrome; Stroke

Outcome Measures

Primary Outcomes (3)

• survival free of discontinuation or alternative prevention drug (migraine trial)

  six months

• survival free of disability measured by FAQ score 9+ (memory trial)

  one year

• survival free of discontinuation or alternative anti epileptic drug (epilepsy trial)

  one year

Study Arms (3)

Treatment A (see interventions description)

ACTIVE COMPARATOR

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.

Drug: Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)

Treatment B (see interventions description)

ACTIVE COMPARATOR

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.

Drug: Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)

Treatment C (see interventions description)

ACTIVE COMPARATOR

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.

Drug: Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)

Interventions

Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description) DRUG

brain tumors (lamotrigine, levetiracetam, valproic acid), epilepsy (lamotrigine, levetiracetam, valproic acid), mild cognitive impairment (donepezil, rivastigmine, memantine), migraine (amitriptyline, propranolol, topiramate), migraine (sumatriptan, rizatriptan, zolmitriptan), mild traumatic brain injury (omega-3 fatty acids, education only), multiple sclerosis (ACTH, methylprednisolone), neuropathy (duloxetine, pregabalin, amitryptiline), Parkinson's disease (pramipexole, ropinerole, rotigotine), restless legs syndrome (pramipexole, ropinerole, rotigotine), stroke (aspirin, clopidogrel).

Also known as: (too many characters to list in this field; see Intervention Description)

Treatment A (see interventions description); Treatment B (see interventions description); Treatment C (see interventions description)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of brain tumors, epilepsy, migraine, mild cognitive impairment (concussion), mild traumatic brain injury, multiple sclerosis, neuropathy, Parkinson's disease, restless legs syndrome, and stroke.
• Eligible to receive any of the three compared treatments according to FDA approval for the indication or off label use according to standard of care.

You may not qualify if:

• \-- None

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (2)

• Maraganore DM, Frigerio R, Kazmi N, Meyers SL, Sefa M, Walters SA, Silverstein JC. Quality improvement and practice-based research in neurology using the electronic medical record. Neurol Clin Pract. 2015 Oct;5(5):419-429. doi: 10.1212/CPJ.0000000000000176.

  PMID: 26576324 BACKGROUND

• Narayanan J, Dobrin S, Choi J, Rubin S, Pham A, Patel V, Frigerio R, Maurer D, Gupta P, Link L, Walters S, Wang C, Ji Y, Maraganore DM. Structured clinical documentation in the electronic medical record to improve quality and to support practice-based research in epilepsy. Epilepsia. 2017 Jan;58(1):68-76. doi: 10.1111/epi.13607. Epub 2016 Nov 19.

  PMID: 27864833 BACKGROUND

Related Links

• Publication
• Project Summary (AHRQ)

MeSH Terms

Conditions

Brain Neoplasms; Epilepsy; Migraine Disorders; Cognitive Dysfunction; Brain Concussion; Multiple Sclerosis; Parkinson Disease; Restless Legs Syndrome; Stroke

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Educator, Department of Neurology

Study Record Dates

• First Submitted: January 23, 2016
• First Posted: February 1, 2016
• Study Start: May 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)