NCT03237650

Brief Summary

Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 30, 2017

Last Update Submit

July 30, 2017

Conditions

Habituation

Keywords

Painful cutaneous electrical stimulationConditioned Pain Modulation

Outcome Measures

Primary Outcomes (2)

  • pain relief

    pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)

    during the measurement

  • N1P1-amplitude

    Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV

    during the measurement

Secondary Outcomes (2)

  • N1-latency

    during the measurement

  • P0N1-amplitude

    during the measurement

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy subjects

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • any kind of disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Christoph Maier, Prof Dr med

    University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 2, 2017

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 2, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share