Status:

COMPLETED

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

Lead Sponsor:

cerbomed GmbH

Conditions:

Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2010

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT01174498

Start Date

November 1 2009

End Date

September 1 2010

Last Update

March 8 2011

Active Locations (1)

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Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg

Regensburg, Bavaria, Germany, 93053