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

This study has been completed.
Sponsor:
Information provided by:
cerbomed GmbH
ClinicalTrials.gov Identifier:
NCT01174498
First received: August 2, 2010
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Pain
Device: Cerbomed t-VNS® transcutaneous stimulation
Device: t-VNS Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by cerbomed GmbH:

Primary Outcome Measures:
  • QST- Quantitative Sensory Testing [ Time Frame: twice a day, two days in total ] [ Designated as safety issue: No ]
    measurement of pain with the qst method before and after the transcutaneous stimulation


Secondary Outcome Measures:
  • Autonomic function measurement [ Time Frame: once a day, two days in total ] [ Designated as safety issue: No ]
    assessed by skin conductance response (SCL), skin conductance reaction (SCR)


Estimated Enrollment: 48
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174498

Locations
Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
cerbomed GmbH
  More Information

No publications provided

Responsible Party: Chief Medical Officer, cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01174498     History of Changes
Other Study ID Numbers: cMPsPAI01
Study First Received: August 2, 2010
Last Updated: March 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by cerbomed GmbH:
discomfort
distress
hurt
sting

ClinicalTrials.gov processed this record on August 28, 2014