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Behavioural Intervention

Non-invasive vagus nerve stimulation (nVNS) for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

N/A
Waitlist Available
Led By Sumit Verma, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12, month 18, month 24
Awards & highlights

Study Summary

This trial will test the feasibility and safety of electrical stimulation as a new potential treatment for pediatric CIDP patients.

Eligible Conditions
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12, month 18, month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12, month 18, month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hand Grip Strength
Nerve Conduction Study - Conduction Amplitude
Nerve Conduction Study - Conduction Velocity
+3 more
Secondary outcome measures
Interleukin (IL)-1β
Tumor Necrosis Factor (TNF)-α

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-invasive vagus nerve stimulation (nVNS)Experimental Treatment2 Interventions
Participants will use the electrical neuromuscular stimulator device, VitalStim 400, which has been used in previous clinical studies for modulation of pain and has received FDA approval. Participants will also continue to take their standard of care medication.

Find a Location

Who is running the clinical trial?

Georgia Institute of TechnologyOTHER
48 Previous Clinical Trials
5,532 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,571 Total Patients Enrolled
Sumit Verma, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

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

Is the demographic for this investigation restricted to those over 35 years of age?

"The medical research team are looking for participants aged between 5 and 21 years old."

Answered by AI

Are any new participants being accepted into this study?

"Affirmative. According to the details provided by clinicaltrials.gov, this study is currently in search of participants. The original post was put up on February 22nd 2022 and updated most recently on September 2nd 2022; 15 individuals are required from two medical sites for enrolment."

Answered by AI

What aims are researchers hoping to accomplish with this clinical trial?

"This experiment is set to observe Change in nerve conduction study F wave latency over a Baseline, Month 12, and Month 24 time frame - its primary outcome. As secondary outcomes will be evaluated the influence of treatment on serum cytokine profiles via measuring TNF-α (Tumor Necrosis Factor Alpha), IL-1β (Interleukin 1 Beta) and HGF (Hepatocyte Growth Factor). Higher levels of these markers are usually associated with CIDP patients; any decrease could indicate that the medication has been effective."

Answered by AI

Would I be eligible to participate in this clinical experiment?

"This clinical trial is seeking 15 children and young adults aged 5-21 suffering from polyradiculoneuropathy, chronic inflammatory demyelinating. To qualify for participation, patients must have a formal diagnosis of CIDP with evidence in their medical record; they are also expected to be receiving treatment using intravenous immunoglobulin (IVIG), steroids or plasma exchange at the time of enrollment."

Answered by AI

How many participants are being included in this clinical trial?

"Affirmative. The clinical trial's page on clinicialtrials.gov confirms that this medical study, initially listed on February 22nd 2022, is actively enrolling patients. A total of 15 individuals are needed to be recruited from 2 sites."

Answered by AI
~1 spots leftby Apr 2025