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

NCT01174498 | Completed

• 1 other identifier: cMPsPAI01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain

Keywords

discomfort; distress; hurt; sting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Autonomic function measurement

  once a day, two days in total

Study Arms (2)

t-VNS sytem Vagus stimulation

ACTIVE COMPARATOR

Subjects experience a transcutaneous vagal stimulation by the t-VNS device

Device: Cerbomed t-VNS® transcutaneous stimulation

Sham transcutaneous stimulation

SHAM COMPARATOR

Sham stimulation with an attached t-VNS device

Device: t-VNS Sham stimulation

Interventions

Cerbomed t-VNS® transcutaneous stimulation DEVICE

Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.

Also known as: Cerbomed t-VNS®

t-VNS sytem Vagus stimulation

t-VNS Sham stimulation DEVICE

t-VNS Sham stimulation

Sham transcutaneous stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• cerbomed GmbH: lead

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Pain; Bites and Stings

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 3, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

DE (1)