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Wearable Sensor Monitoring for Cervical Spine Fusion Recovery

N/A
Waitlist Available
Led By Alpesh A Patel, BSE, MD, MBA
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged between 18 to 88 years at time of surgery
Patients who have undergone anterior cervical discectomy and fusion (ACDF) for one or more levels for a diagnosis of cervical radiculopathy or myelopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 24 hours post operative
Awards & highlights

Study Summary

This trialwill test a noninvasive, skin-like electronic sensor to monitor recovery of patients who've had ACDF surgery. Physiological signals like heart rate, respiratory rate, and more will be measured.

Who is the study for?
This trial is for individuals aged 18 to 88 who have had ACDF surgery for cervical radiculopathy or myelopathy and are scheduled for a post-op clinic visit. It excludes those with revised ACDF, surgeries due to trauma or cancer, and vulnerable groups like prisoners or pregnant women.Check my eligibility
What is being tested?
The study tests a new wearable skin sensor called ADAM mechanoacoustic sensor on patients after ACDF surgery. It aims to wirelessly monitor recovery by measuring heart rate, breathing rate, swallowing frequency, talking time, energy use, neck motion, and body position.See study design
What are the potential side effects?
Since the intervention involves wearing a noninvasive sensor rather than medication or invasive procedures, significant side effects are not anticipated in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 88 years old.
Select...
I had surgery to remove a disc in my neck due to nerve or spinal cord issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 24 hours post operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 hours post operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscular Force Generated During Range of Motion Exercises
Skin Temperature of the Surgical Site
Vibrational Frequency of Vocalization Following Surgery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Wearable Sensor AppliedExperimental Treatment2 Interventions
For these participants, the wearable ADAM sensor will be placed in the sternal notch to record anatomical data during the post-surgical period for up to 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anterior Cervical Discectomy & Fusion
2015
N/A
~150

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,576 Previous Clinical Trials
911,911 Total Patients Enrolled
Alpesh A Patel, BSE, MD, MBAPrincipal InvestigatorNorthwestern University

Media Library

Anterior Cervical Discectomy & Fusion Clinical Trial Eligibility Overview. Trial Name: NCT04921800 — N/A
Cervical Spine Fusion Research Study Groups: Wearable Sensor Applied
Cervical Spine Fusion Clinical Trial 2023: Anterior Cervical Discectomy & Fusion Highlights & Side Effects. Trial Name: NCT04921800 — N/A
Anterior Cervical Discectomy & Fusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921800 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can persons younger than 65 years old partake in this clinical trial?

"Eligibility for this trial is limited to patients aged 18-88. Specialized studies exist for younger than 18, and those exceeding 65 years of age with two separate trials available in each category."

Answered by AI

Are there any spaces available for enrolment in this research study?

"As per the information on clinicaltrials.gov, this trial is no longer accepting candidates for participation. It was initially posted on March 15th 2021 but has since been updated to reflect its lack of active recruitment status as of November 10th 2022. Fortunately, there are two other trials that individuals can join in their stead."

Answered by AI

Could I potentially be included in this scientific research?

"This research requires 11 individuals who have undergone cervical spine fusion to join. The age range is wide, consisting of those aged 18-88 years old at the time of surgery and with a follow up appointment scheduled for the MSK orthopaedic clinic."

Answered by AI
~3 spots leftby Mar 2025