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

NCT03772717 | Terminated Results FDA Device

• 1 other identifier: IRB00098592
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will be requested to deliver non-invasive vagus nerve stimulation (nVNS) two times per day, at least five days per week. Participants will be followed for two years with nVNS as an adjunctive therapy to the standard of care therapy for chronic inflammatory demyelinating polyneuropathy (CIDP).

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Pediatrics; Vagus nerve stimulation

Outcome Measures

Primary Outcomes (6)

• Nerve Conduction Study - Distal Latency

  Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Latency is the time it takes in milliseconds (ms) for the electrical impulse to travel to the site receiving the stimulation.

  Baseline, Month 12, Month 24

• Nerve Conduction Study - F Wave Latency

  Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. F wave latency is the time it takes in milliseconds (ms) for an electrical signal to travel from the stimulating electrode to the distal muscle and back to the stimulating site. F waves are used to assess polyneuropathy and F wave latency can be extended or even absent in persons with CIDP.

  Baseline, Month 12, Month 24

• Nerve Conduction Study - Conduction Velocity

  Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Conduction velocity measures the rate of impulse conduction in meters per second (m/s) and is often decreased in patients with CIDP as myelination is affected.

  Baseline, Month 12, Month 24

• Nerve Conduction Study - Conduction Amplitude

  Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Conduction amplitude is the size of the response to electrical stimulation, measured in millivolts (mV). Reduced amplitude indicates axon loss.

  Baseline, Month 12, Month 24

• Hand Grip Strength

  Hand grip strength is assessed with a Jamar Handheld Dynamometer for children ages 5-18 years and measures strength in kilograms (kg). Both right and left hand grip strength were measured and the best of three attempts were used for each hand. Increased hand strength is an indicator of effective treatment.

  Baseline, Month 6, Month 12, Month 18, Month 24

• Rasch-built Overall Disability Scale (R-ODS) for CIDP Score

  The Rasch-built Overall Disability Scale (R-ODS) used for those with Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), and gammopathy-related polyneuropathy (MGUSP) is a 24-item scale asking respondents to rate how greatly polyneuropathy impacts activities. Responses are given on a scale of 0 to 2 where 0 indicates it is not possible for the respondent to perform the task and 2 means that the task can be performed without difficulty. Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks.

  Baseline, Month 6, Month 12, Month 18, Month 24

Secondary Outcomes (2)

• Tumor Necrosis Factor (TNF)-α

  Baseline, Month 6, Month 12, Month 18, Month 24

• Interleukin (IL)-1β

  Baseline, Month 6, Month 12, Month 18, Month 24

Study Arms (1)

Non-invasive vagus nerve stimulation (nVNS)

EXPERIMENTAL

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.

Device: Non-invasive vagus nerve stimulation (nVNS); Other: Standard of care treatment

Interventions

Non-invasive vagus nerve stimulation (nVNS) DEVICE

The nVNS study intervention will be delivered using a handheld electrical neuromuscular stimulator device (VitalStim 400). Participants will deliver nVNS twice per day for 60 minutes each time at least 5 days per week. The two electrodes for the device will be placed on the subjects left cervical (neck) region. 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. The stimulator will be placed in a comfortable position, such as next to the pillow. The stimulators are battery-powered and allow configuration of the stimulation parameters to the comfort of the patient.

Also known as: VitalStim 400

Non-invasive vagus nerve stimulation (nVNS)

Standard of care treatment OTHER

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).

Also known as: intravenous immunoglobulin (IVIG), plasma exchange (PLEX)

Non-invasive vagus nerve stimulation (nVNS)

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of CIDP based upon clinical/electrophysiological criteria
• On treatment for CIDP including IVIG and/ or steroids/plasma exchange

You may not qualify if:

• Inherited polyneuropathy, such as Charcot Tooth Marie disease
• Abnormal baseline EKG, heart disease, epilepsy, pregnancy, multiple sclerosis and diabetes mellitus

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator

Study Sites (1)

Children's Healthcare of Atlanta, Center for Advanced Pediatrics

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous; Plasma Exchange

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Sumit Verma, MD
• Organization: Emory University

sumit.verma@emory.edu

404-785-9893

Study Officials

• Sumit Verma, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Robert Butera, PhD

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: February 22, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 14, 2023
• Results First Posted: July 14, 2023

Record last verified: 2023-06

Locations

US (1)