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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1
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg
Regensburg, Bavaria, Germany, 93053