Cervical Radiculopathy Imaging Using MRN With Electrodiagnostic Correlation

NCT06971575 | Recruiting

• 1 other identifier: 2023-1447
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This project will study patients with cervical radiculopathy. We will evaluate the combined diagnostic and prognostic value of magnetic resonance neurography (MRN), electrodiagnostic (EDX) studies, and historical and physical clinical elements. Specifically, this project will explore whether these data individually or in combination correlate with response to procedural and non-procedural treatment.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (2)

• Presence of abnormalities on nerve (MRN) imaging

  Presence of abnormalities on cervical MRN imaging that correspond to clinical findings of cervical radiculopathy. This includes abnormalities in extraforaminal cervical nerve root intraneural T2 signal and DTI values.

  Baseline

• Relationship between abnormalities on imaging and electrodiagnostic assessment

  The relationship between any abnormalities identified on nerve imaging (cervical MRN) and electrodiagnostic findings will be assessed.

  Baseline

Secondary Outcomes (2)

• Numeric rating scale (NRS) pain

  Baseline, 3 months, 6 months, 12 months

• Neck Disability Index (NDI)

  Baseline, 3 months, 6 months, 12 months

Study Arms (1)

Cervical Radiculopathy Patients

Patients diagnosed with unilateral cervical radiculopathy and signs of clinical weakness.

Diagnostic Test: Magnetic resonance neurography

Interventions

Magnetic resonance neurography DIAGNOSTIC_TEST

Patients will undergo a cervical MRI with specialized magnetic resonance neurography sequences to evaluate the extraforaminal cervical nerve roots.

Cervical Radiculopathy Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or subacute unilateral cervical radiculopathy and signs of clinical weakness

You may qualify if:

• Patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness
• years old at the time of evaluation
• Symptom onset of 2 to 12 weeks leading up to baseline visit
• Diagnosis of unilateral cervical radiculopathy, with or without spinal cord compression, based on signs and symptoms, physical exam and supported by MRI findings of radiculopathy (as evidenced by foraminal stenosis/narrowing) based on standard-of-care cervical spine MRI
• Patients who have undergone or have planned electrodiagnostic testing at HSS prior to surgery

You may not qualify if:

• Prior cervical surgery or instrumentation
• Those who have had a prior episode of cervical radiculopathy
• History of peripheral neuropathy or another acute or chronic neurodegenerative condition
• History of stroke, cerebellar disease, or central nervous system disease
• Contraindications to undergoing a standard MRI examination (e.g., pregnancy)
• Patients presenting with bilateral cervical radiculopathy

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

J. Levi Chazen, MD

CONTACT

212-774-7149; chazenjl@hss.edu

Carlo Milani, MD

CONTACT

milanic@hss.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 14, 2025
• Study Start: October 24, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)