Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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ClinicalTrials.gov Identifier: NCT03772717 |
Recruitment Status :
Recruiting
First Posted : December 11, 2018
Last Update Posted : September 6, 2022
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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 VitalStim 400, which has been used in multiple previous clinical studies for modulation of pain and has received FDA approval. A total of 15 pediatric chronic inflammatory demyelinating polyneuropathy (CIDP) patients will be included in the study. Study participants will have baseline EKG. The electrodes for the device will be placed on the subjects left cervical (neck) region. The stimulators are battery-powered and allow configuration of the stimulation parameters to the comfort of the patient.
Participants will be requested to deliver stimulations two times per day for two years. Study outcomes would include quantification of the functional changes in motor nerve conduction studies, hand held grip strength, Rash-built Overall Disability Scale (R-ODS) and changes in serum cytokine profiles at baseline and on regular follow-up visits.
Condition or disease | Intervention/treatment | Phase |
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Chronic Inflammatory Demyelinating Polyneuropathy | Device: VitalStim 400 Device: VitalStim400 | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Participants will receive a device that delivers electrical neuromuscular stimulation. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
Actual Study Start Date : | February 22, 2022 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
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Experimental: VitalStim400
The stimulation devices used in this study are VitalStim 400, electrical neuromuscular stimulators, which have been used in multiple previous clinical studies for modulation of pain and have received FDA approval. The (2) electrodes for the device will be placed on the subjects left cervical (neck) region. 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. 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. |
Device: VitalStim 400
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 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. Device: VitalStim400 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).
Other Names:
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- Change in nerve conduction study distal latency [ Time Frame: Baseline, Month 12, Month 24 ]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 will stimulate 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.
- Change in nerve conduction study F wave latency [ Time Frame: Baseline, Month 12, Month 24 ]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 will stimulate 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.
- Change in nerve conduction study conduction velocity [ Time Frame: Baseline, Month 12, Month 24 ]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 will stimulate 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 (distance/time) and is often decreased in patients with CIDP as myelination is affected.
- Change in nerve conduction study conduction amplitude [ Time Frame: Baseline, Month 12, Month 24 ]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 will stimulate 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.
- Change in hand grip strength [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]Hand grip strength will be assessed with a Jamar Handheld Dynamometer with reference range (in kilograms and pounds) for children ages 5-18 years. Both right and left hand grip strength will be measured and the best of three attempts will be used for each hand. Increased hand strength is an indicator of effective treatment.
- Change in Rasch-built Overall Disability Scale (R-ODS) for CIDP [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]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 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.
- Change in tumor necrosis factor (TNF)-α [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]The impact of treatment on serum cytokine profiles will be assessed by measuring TNF-α. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. TNF-α is elevated in CIDP patients and a decrease in serum TNF-α is an indication of effective treatment.
- Change in hepatocyte growth factor (HGF) [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]The impact of treatment on serum cytokine profiles will be assessed by measuring HGF. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. HGF is elevated in CIDP patients and a decrease in HGF values is an indication of effective treatment.
- Change in macrophage inflammatory protein (MIP)-1β [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]The impact of treatment on serum cytokine profiles will be assessed by measuring MIP-1β. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. MIP-1β is elevated in CIDP patients and a decrease in MIP-1β values is an indication of effective treatment.
- Change in interleukin (IL)-1β [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24 ]The impact of treatment on serum cytokine profiles will be assessed by measuring IL-1β. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. IL-1β is elevated in CIDP patients and a decrease in IL-1β values is an indication of effective treatment.

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Ages Eligible for Study: | 5 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Diagnosis of CIDP based upon clinical/electrophysiological criteria
- Patient should be on treatment for CIDP including IVIG and/ or steroids/ plasma exchange
- 5-21 years of age
Exclusion criteria
- Patients will be excluded from the study if they have inherited polyneuropathy, such as Charcot Tooth Marie disease.
- Abnormal baseline EKG, heart disease, epilepsy, pregnancy, multiple sclerosis and diabetes mellitus.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772717
Contact: Sumit Verma, MD | 404-785-9893 | sumit.verma@emory.edu |
United States, Georgia | |
Center for Advanced Pediatrics, Children's Healthcare of Atlanta, 1400 Tullie Road, | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Sumit Verma, MD 404-785-9893 sumit.verma@emory.edu |
Principal Investigator: | Sumit Verma, MD | Emory University | |
Principal Investigator: | Robert Butera, PhD | Georgia Institute of Technology |
Responsible Party: | Sumit Verma, Associate Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT03772717 |
Other Study ID Numbers: |
IRB00098592 |
First Posted: | December 11, 2018 Key Record Dates |
Last Update Posted: | September 6, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Pediatrics Vagus nerve stimulation |
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Immunoglobulins Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |