Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Sponsors

Lead Sponsor: Emory University

Collaborator: Georgia Institute of Technology

Source Emory University
Brief Summary

This study will be conducted at Children's Healthcare of Atlanta, in Atlanta, Georgia for a total duration of 24 months. The electrical neuromuscular stimulation device used in this study is the Vital EMS+, which has been used in multiple previous clinical studies for modulation of pain and has received FDA approval. A total of 10 study participants will be randomly assigned to one of two groups in the study: 5 will receive the standard of care treatment plus electrical neuromuscular stimulation and 5 will receive standard of care and devices that do not deliver electrical stimulation (sham device). Participants will be requested to deliver nVNS two times per day, at least five days per week in their home, for two years.

Detailed Description

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic immune-mediated disease of the peripheral sensory motor nerves characterized by motor weakness, sensory loss, muscle wasting and loss of motor ability. Treatment of CIDP involves chronic use of steroids, intravenous immunoglobulin (IVIG) and rarely plasma exchange (PLEX). Outcome measures such as patient reported motor disability scores, electrophysiology parameters, functional motor strength testing are available to look for interval change. Despite above mentioned treatments, the majority of patients have tremendous disease burden. There is a need for alternative/adjunctive therapies that can decrease chronic inflammation effectively and safely in pediatric CIDP patients. Vagus nerve stimulation (VNS) has received significant scientific and clinical attention and has been shown to effectively reduce systemic inflammation. Results from early clinical trials for treatment of Rheumatoid Arthritis have demonstrated significant lifestyle benefits and reduced symptoms in these patients. Similar benefits of VNS have been observed in Crohn's patients. In these studies, patients are surgically implanted with a stimulator with electrodes directly on the nerve. Preliminary results have demonstrated safety and efficacy in patients that previously were unresponsive to traditional pharmacological therapies. Unfortunately, surgical implantation of a device is difficult and costly. Recent investigations have significantly increased our understanding of non-invasive vagus nerve stimulation (nVNS). Compared to traditional implanted vagus nerve stimulation devices, nVNS uses electrodes placed on the skin surface to stimulate the vagus nerve and has shown promise in animal and human models to reduce chronic inflammation in multiple disease states. By delivering electrical pulses at the skin surface above the vagus nerve, neural pathways involved in regulating systemic inflammation are activated. Using a handheld device, patients apply a brief duration of stimulation multiple times per day to achieve therapeutic benefit. nVNS is currently FDA approved for clinical use in the treatment of migraines and cluster headaches, with on-going clinical studies on epilepsy and systemic inflammation. Preliminary published results have demonstrated significant therapeutic benefit to the patients with minimal side-effects. Ten study participants will be randomly assigned to one of two groups in the study: those receiving the standard of care treatment plus electrical neuromuscular stimulation and those receiving the standard of care treatment and devices that do not deliver electrical stimulation (sham device). Participants will be requested to deliver nVNS two times per day, at least five days per week in their home, for two years.

Overall Status Not yet recruiting
Start Date January 1, 2021
Completion Date December 2022
Primary Completion Date December 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in nerve conduction study distal latency Baseline, Month 12, Month 24
Change in nerve conduction study F wave latency Baseline, Month 12, Month 24
Change in nerve conduction study conduction velocity Baseline, Month 12, Month 24
Change in nerve conduction study conduction amplitude Baseline, Month 12, Month 24
Change in hand grip strength Baseline, Month 6, Month 12, Month 18, Month 24
Change in Rasch-built Overall Disability Scale (R-ODS) for CIDP Baseline, Month 6, Month 12, Month 18, Month 24
Secondary Outcome
Measure Time Frame
Change in tumor necrosis factor (TNF)-α Baseline, Month 6, Month 12, Month 18, Month 24
Change in hepatocyte growth factor (HGF) Baseline, Month 6, Month 12, Month 18, Month 24
Change in macrophage inflammatory protein (MIP)-1β Baseline, Month 6, Month 12, Month 18, Month 24
Change in interleukin (IL)-1β Baseline, Month 6, Month 12, Month 18, Month 24
Enrollment 10
Condition
Intervention

Intervention Type: Device

Intervention Name: Vital EMS+

Description: The nVNS study intervention will be delivered using a handheld electrical neuromuscular stimulator device (Vital EMS+). Participants will deliver nVNS twice per day for 60 minutes each time at least 5 days per week, for 2 years. The two electrodes for the device are placed on the left cervical (neck) region or on the left ear. Parents will be trained on where to place electrodes, how to ensure that the electrodes make a good contact with the skin, and how to set the stimulation parameters. The stimulation frequency (number of pulses) and amplitude (amount of current) will be set during the initial baseline session in the clinic at a level that prevents discomfort and does not impact cardiorespiratory parameters.

Arm Group Label: Vital EMS+

Intervention Type: Drug

Intervention Name: Standard of Care

Description: Patients will be asked to continue their standard medication regimens which include in most cases will involve 3 weekly infusions of intravenous immunoglobulin (IVIG) (1 gm/kg) and rarely plasma exchange (PLEX).

Eligibility

Criteria:

Inclusion Criteria: - Diagnosis of CIDP based upon clinical/electrophysiological criteria - Patient should be on treatment for CIDP including IVIG and Steroids Exclusion Criteria: - Patients will be excluded from the study if they have inherited polyneuropathy, such as Charcot Tooth Marie disease.

Gender: All

Minimum Age: 5 Years

Maximum Age: 21 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Sumit Verma, MD

Phone: 404-785-9893

Email: [email protected]

Location
Facility: Contact: Childrens Healthcare of Atlanta Sumit Verma, MD 404-785-9893 [email protected]
Location Countries

United States

Verification Date

December 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Emory University

Investigator Full Name: Sumit Verma

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Vital EMS+

Type: Experimental

Description: Participants will receive electrical neuromuscular stimulation via a Vital EMS+ device, along with the standard of care treatment.

Label: Sham device

Type: Sham Comparator

Description: Participants will receive a sham device that does not deliver electrical neuromuscular stimulation, along with the standard of care treatment.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Participants will be randomized to receive a device that delivers electrical neuromuscular stimulation or a sham device.

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov