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Lateralization of the analgesic effect of the transcutaneous vagus nerve stimulation (t-VNS®) in human

Organizational Data

DRKS-ID:
DRKS00003383
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2011-12-20
Last update in DRKS:
2014-02-27
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Invasive vagus nerve stimulation (VNS) is an approved therapy in the treatment of drug-resistant epilepsy. The development of a medical device to apply transcutaneous vagus nerve stimulation (t-VNS) responds to the demand for a non-invasive therapy with low side-effects. During t-VNS electrical pulses are delivered via electrodes which are placed on the skin of the outer ear. In patients suffering from migraine a reduction in headaches could be observed during treatment with invasive VNS. Furthermore, an inhibitory effect of t-VNS on pain was proved in a recent study in healthy volunteers. This analgesic effect was more pronounced for the same side of the body that was treated with t-VNS. Based on this results the pain perception in healthy volunteers during left- and right-sided t-VNS and therefore the lateralization (Latin latus = side) of t-VNS should be investigated in this research project. So called psychophysical measurements, the self-assessment of stimulus intensities by the volunteers, will be applied to determine changes in pain processing during right- and left-sided t-VNS.

Brief summary in scientific language

Invasive vagus nerve stimulation (VNS) is an approved therapy in the treatment of drug-resistant epilepsy. Transcutaneous vagus nerve stimulation (t-VNS), a non-invasive intervention, utilizes the fact that the auricular branch of the vagus nerve supplies the cymba conchae of the human ear exclusively. A special ear electrode guarantees that electrical impulses from the pulse generator, which is connected by cable, can be accurately delivered transcutaneously. Modulation of nociception and pain processing during stimulation of vagal afferents has been documented both in animal and human studies. Patients with epilepsy, who were treated with invasive VNS, showed a significant increase in pressure pain thresholds and a reduction in wind-up compared to a control group. Furthermore, a recent study in healthy volunteers proved t-VNS to have an influence on pain perception as well. Thus, a standardized protocol was used to apply psychophysical measurements on both hands. The results indicated a pronounced ipsilateral increase in pressure pain threshold and a more potent ipsilateral decrease in mechanical pain sensitivity during left-sided t-VNS. In this study, the lateralization of the analgesic effect of left- and right-sided t-VNS should be investigated. It is hypothesized that left-sided as well as right-sided t-VNS show an antinociceptive pattern which is more pronounced ipsilaterally.

Health condition or problem studied

Free text:
Healthy volunteers
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
verum left - adjustment of the ear electrodes at both sides, left-sided transcutaneous vagus nerve stimulation (t-VNS): frequency 25 Hz, adjust stimulation intensity above perception threshold and below pain threshold
Arm 2:
verum right - adjustment of the ear electrodes at both sides, right-sided t-VNS: frequency 25 Hz, adjust stimulation intensity above perception threshold and below pain threshold
Arm 3:
sham - adjustment of the ear electrodes at both sides, no t-VNS

Endpoints

Primary outcome:
psychophysical measurement of the pressure pain threshold (PPT) at the left and right hand ipsilateral and contralateral to t-VNS time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST)
Secondary outcome:
psychophysical measurement of the mechanical pain threshold (MPT) and the mechanical pain sensitivity (MPS) at the left and right hand ipsilateral and contralateral to t-VNS measurement of blood pressure and pulse time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST) sensitive sensations (self-evaluation by the volunteer) questionnaire for vegetative symptoms (self-evaluation by the volunteer): assessment of any vegetative changes during measurements (increase/decrease e.g. salivation, lacrimation etc.). number of adverse events / incidents

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
No Entry

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2011-11-07
Planned study completion date:
No Entry
Actual Study Completion Date:
2012-03-28
Target Sample Size:
50
Final Sample Size:
50

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
55 Years
Additional Inclusion Criteria:
healthy volunteers healthy in terms of medical history written informed consent form after volunteer information

Exclusion Criteria

participation in a clinical trial within the last 4 weeks prior inclusion pregnant or breastfeeding women any medication (except contraceptives) anatomical and pathological abnormalities of the ears indications that the participant is expected not to comply with the clinical investigation plan (e.g. lacking willingness to cooperate)

Addresses

Primary Sponsor

cerbomed GmbH
Dr. Andreas Hartlep
Henkestr. 91
91052 Erlangen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

cerbomed GmbH
Dr. Andreas Hartlep
Henkestr. 91
91052 Erlangen
Germany
Telephone:
+49 9131 9202 76 0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

cerbomed GmbH
Dr. Andreas Hartlep
Henkestr. 91
91052 Erlangen
Germany
Telephone:
+49 9131 9202 76 0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

cerbomed GmbH
Dr. Andreas Hartlep
Henkestr. 91
91052 Erlangen
Germany
Telephone:
+49 9131 9202 76 0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

cerbomed GmbH
Henkestr. 91
91052 Erlangen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Bayerischen Landesärztekammer
Mühlbaurstr. 16
81677 München
Germany
Telephone:
+49-89-4147165
Fax:
+49-89-4147334
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2011-09-05
Ethics committee number:
11103
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-10-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry