Cervical RadiculopathyNCT06971575
Cervical Radiculopathy Imaging Using MRN With Electrodiagnostic Correlation
An observational study of Cervical Radiculopathy, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Magnetic resonance neurography
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with acute or subacute unilateral cervical radiculopathy and signs of clinical weakness
Who may be able to join
- Patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness
- 18-60 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlo Milani, MD contact
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
J. Levi Chazen, 212-774-7149, chazenjl@hss.edu
J. Levi Chazen, MD
About this study
Official title: Cervical Radiculopathy Imaging Using MR Neurography With Electrodiagnostic Correlation
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
- Being tested
- Magnetic resonance neurography
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance neurographyDiagnostic test
Patients will undergo a cervical MRI with specialized magnetic resonance neurography sequences to evaluate the extraforaminal cervical nerve roots.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Radiculopathy Patients | Patients diagnosed with unilateral cervical radiculopathy and signs of clinical weakness. Receives: Diagnostic Test: Magnetic resonance neurography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
Numeric rating scale (NRS) pain
Current NRS pain will be assessed on 0-10 scales (10=worst pain).
Measured: Baseline, 3 months, 6 months, 12 months
Neck Disability Index (NDI)
NDI is scored on a 0-100% scale, with 100% representing complete disability.
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start24 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971575
- Sponsor's protocol ID
- 2023-1447
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Radiculopathy Imaging Using MR Neurography With Electrodiagnostic Correlation
- ClinicalTrials.gov ID
- NCT06971575
- Acronym / sponsor ID
- 2023-1447
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Radiculopathy Patients | – | Diagnostic Test: Magnetic resonance neurographyPatients diagnosed with unilateral cervical radiculopathy and signs of clinical weakness. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with acute or subacute unilateral cervical radiculopathy and signs of clinical weakness
Key inclusion criteria (5 listed)
- Patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness
- 18-60 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance neurographyPatients will undergo a cervical MRI with specialized magnetic resonance neurography sequences to evaluate the extraforaminal cervical nerve roots. | Diagnostic test | Cervical Radiculopathy Patients |
Primary outcome
Presence of abnormalities on nerve (MRN) imaging
Time frame: Baseline
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.
Relationship between abnormalities on imaging and electrodiagnostic assessment
Time frame: Baseline
The relationship between any abnormalities identified on nerve imaging (cervical MRN) and electrodiagnostic findings will be assessed.
2 secondary outcomes
Numeric rating scale (NRS) pain
Time frame: Baseline, 3 months, 6 months, 12 months
Neck Disability Index (NDI)
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Milani, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Levi Chazen, MD (212-774-7149, chazenjl@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of abnormalities on nerve (MRN) imaging (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.