Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

— AuriMod  

Official title:

Personalized Auricular Vagus Nerve Stimulation in Patients With Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753528
• Other study ID #: AT-MF-000000433-CIV-001
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: October 25, 2022

Study information

• Verified date: January 2023
• Source: Aurimod GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One in five people in the general adult population suffer from chronic pain, a figure that is higher than heart disease, cancer, and diabetes combined. A majority of these patients is suffering from chronic back pain. Conventional treatment options offer only a partial response, with many people continuing to suffer severe chronic pain, despite receiving several treatments.

Non-pharmacological treatments by neuromodulation represent a promising treatment modality for these patients. For instance, spinal cord stimulation blocks pain signals travelling to the brain, but requires implantation near the spine with significant clinical risks. Vagus nerve stimulation (VNS) is another neuromodulation modality proposed to alleviate chronic pain. Conventional VNS devices are implanted under the skin on the chest and the electrodes are wired to the left vagus nerve in the neck. However, aside from implantation risks, VNS is often associated with side effects such as swallowing difficulties, due to unwanted stimulation of motoric vagus nerve branches in the neck.

Percutaneous auricular VNS (pVNS) is an emerging technology for stimulation of the auricular branch of the vagus nerve in the pinna of the ear. Specific electrical impulses are applied via three miniature needle electrodes located in the auricle near sensory vagus nerve fibers. Scientific data show that pVNS modulates brain circuits involved in autonomic control and pain processing. pVNS has shown positive effects in chronic low-back pain patients, in a sustainable way with a low side-effect profile. However, the optimal settings of stimulation with regards to personalization remain to be elucidated.

The present prospective, open, randomized, controlled pilot study aims at evaluating the performance of pVNS treatment, using a small wearable stimulation device (AuriMod CT01), comparing personalized and non-personalized stimulation paradigms in patients with chronic low-back pain. Patients will be randomized in one of the following treatment groups (1) Group A: Stimulation with personalized stimulation parameters and amplitude, (2) Group B: Stimulation with personalized stimulation amplitude, (3) Group C: Stimulation without personalization (comparator group).

Patients will be treated for 8 weeks. Patients will receive standardized pain medication including rescue medication in parallel. An additional follow-up period of 12 weeks allows to evaluate sustainable and late-time effects of treatment. Patients will use a therapy management system to monitor outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18 to 65 years at screening

• Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures

• Chronic back pain with or without leg pain (CBLP) persisting for at least 3 months

• A minimum of 70 (out of 180) points on the Computer User Self-Efficacy Scale at the screening visit

• Patient is constant with respect to pain treatment during the screening phase

• A daily average VAS >= 4 on at least half of the days in the screening phase

• Compliance with the daily status reporting requirements as demonstrated by having valid required data entries for all days. It is acceptable if data of one day is missing in the screening phase

Exclusion Criteria:

• Patients with age under 18

• Hemophilia

• Infection, eczema, or psoriasis at application site

• Numbed and desensitized skin at the application site

• Florid malignant diseases

• Mental and physical impairments that represent a source of risk for handling the device

• The presence of a cardiac pacemaker, defibrillator, cochlear implant, or other active implantable device

• Vagal hypersensitivity

• Indication for back surgery

• High-grade spinal stenosis

• Patients with other active implants

• Patients with autonomic disorders

• Patients with diabetes type I or II

• Patients taking Beta-Blockers

• Patients taking drugs carrying the potential risk of arrhythmia (tricyclic medications, Alzheimer drugs, etc.)

• Clinically significant hip or knee arthritis

• Allergy against rescue medication used during the study

• History of Vagus Nerve Stimulation

• Pregnant or nursing female patients

• Patients with arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies detected during ECG at screening

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Device:
• AuriMod CT01_A
AuriMod CT01 is a wearable medical device for personalised pain treatment through auricular vagus nerve stimulation. AuriMod CT01 is a battery-operated electrical stimulation device, to be placed behind the ear on the neck. AuriMod CT01 connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a personalized set of stimulation parameters and adjustable amplitude.
• AuriMod CT01_B
AuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude.
• AuriMod CT01_C
AuriMod CT01 with a fixed set of stimulation parameters and amplitude.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Carinthia
Switzerland	Hopital de La Tour	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Aurimod GmbH	Klinikum Klagenfurt am Wörthersee, La Tour Hospital

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome 1	Incidence of Adverse Events (AEs) and Device Deficiencies (DDs) observed until EoT	8 weeks
Other	Safety Outcome 2	Incidence of Serious Adverse Events (SAEs) and related AEs observed until end of follow-up	20 weeks
Primary	Average VAS	Change from baseline to End of Treatment (EoT) in average Visual Analogue Scale (VAS; scale 0-10, steps 0.1, 0...no pain, 10...worst pain) during the last 24 hours before the visit	8 weeks
Secondary	Max/Min VAS	Change from baseline to EoT in max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)	8 weeks
Secondary	Average/Max/Min VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)	Change from baseline to End of Follow-Up in average/max/min VAS	20 weeks
Secondary	Normalized average/max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)	Baseline-adjusted area under the max/min/average VAS from baseline to EoT	8 weeks
Secondary	VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)	VAS during follow-up	12 weeks
Secondary	Medication use	Pain and rescue medication consumption during treatment and follow-up phase	20 weeks
Secondary	Heart Rate	Change in heart rate over therapy and follow-up	20 weeks
Secondary	Heart Rate Variability	Change in heart rate variability over therapy and follow-up	20 weeks
Secondary	Blood Pressure	Change in blood pressure over therapy and follow-up	20 weeks
Secondary	Patient motility	Change in daily step count over therapy and follow-up	20 weeks
Secondary	painDETECT	painDETECT questionnaire over treatment and follow-up	20 weeks
Secondary	EQ-5D-5L	EQ-5D-5L questionnaire over treatment and follow-up	20 weeks
Secondary	HADS	Hospital Anxiety and Depression Score (HADS) over treatment and follow-up	20 weeks
Secondary	Sleep quality	Sleep quality (5-item questionnaire) over treatment and follow-up	20 weeks
Secondary	Wellbeing	Subjective wellbeing (on a 3-point ordinal scale: good, medium, bad)	20 weeks
Secondary	Perception Scale	AuriMod CT01 Perception Scale evaluating the quality of stimulation perception in a 10-item questionnaire at EoT	8 weeks
Secondary	Usability Scale	AuriMod CT01 Usability scoring using the System Usability Scale (10-item scale from 10-50, 10...worst usability, 50...best usability) at EoT	8 weeks
Secondary	Socioeconomic data	Socioeconomic data change over treatment and follow-up	20 weeks