Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System

Controlled, Randomized Study of Pain Perception and Psychophysiological Reactions of the Autonomic Nervous System Under Transcutaneous, Electrical Stimulation of the Vagus Nerve in Healthy Volunteers

The increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies. In the recent years neurostimulating techniques have been a promising approach regarding their analgesic effect. Combined with therapeutic standard procedures they can increase these effects and can have a positive impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient analgesic method in animal experiments and open clinical pilot studies amongst humans. Despite the lack of controlled approaches applying the method against defined pain syndromes, the stimulation of the vagus nerve has shown up as an effective method treating other psychiatric diseases like depression. The processing of stress, which is involved directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation. Compared with invasive methods the transcutaneous stimulation offers obvious advantages concerning appliance and occurrence of side effects. There are no studies so far dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of defined (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change of experiencing pain when applying the t-VNS in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Cerbomed t-VNS® transcutaneous stimulation; Device: t-VNS Sham stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Regensburg, Bavaria, Germany, 93053
      • Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: Minimum: 18 years Maximum: no limit
• Both Gender
• Normal psychiatric medical history
• Normal neurological report

Exclusion Criteria:

• Psychiatric disease incl. pain-related diseases
• Subject is on medication
• Abuse of drugs or alcohol until 12 weeks before enrollment in the study
• Actual wearing conditions
• Pronounced lack of sleep within the last 2 days of enrollment
• Excessive consumption of alcohol in the last 2 days
• Peripheral neuropathy
• Severe neurological diseases (cerebrovascular diseases, traumatic brain injury, epilepsy, Morbus Parkinson, dementia, systemic neurologic diseases etc.)
• migraine
• carpal tunnel syndrome or other entrapment syndromes
• missing Informed Consent
• Pregnancy
• active implant (like cochlea implant, VNS, pacemaker)
• severe internistic diseases (e.g. arterial hypertension, respiratory failure)
• malignant diseases within the last five years
• severe acute infections (e.g. HIV, hepatitis)
• diseases of the ENT bodysystem: Hearing loss of the left ear which is treated with an hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal
• Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: t-VNS sytem Vagus stimulation; Subjects experience a transcutaneous vagal stimulation by the t-VNS device	Device: Cerbomed t-VNS® transcutaneous stimulation; Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.; Other Names: Cerbomed t-VNS®
Sham Comparator: Sham transcutaneous stimulation; Sham stimulation with an attached t-VNS device	Device: t-VNS Sham stimulation; t-VNS Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QST- Quantitative Sensory Testing	measurement of pain with the qst method before and after the transcutaneous stimulation	twice a day, two days in total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic function measurement	assessed by skin conductance response (SCL), skin conductance reaction (SCR)	once a day, two days in total

Collaborators and Investigators

• Sponsor: cerbomed GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2011
• Last Update Submitted That Met QC Criteria: March 7, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: distress; discomfort; hurt; sting
• Other Study ID Numbers: cMPsPAI01