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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:
ClinicalTrials.gov Identifier:
NCT01174498
First Posted: August 3, 2010
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
cerbomed GmbH
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01174498


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

Responsible Party: Chief Medical Officer, cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01174498     History of Changes
Other Study ID Numbers: cMPsPAI01
First Submitted: August 2, 2010
First Posted: August 3, 2010
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by cerbomed GmbH:
discomfort
distress
hurt
sting