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Completed

NCT Number: NCT02159170

Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor

Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. The investigators plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.

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Key information

Conditions

Non-inflammatory Neuropathic Pain Healthy Subjects

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Mental Health

Mannheim, 68159, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no acute or chronic disease
  • no acute or chronic pain
  • age: 18-60 years
  • male
  • no medication use

Exclusion criteria

  • metallic parts in the body
  • claustrophobia
  • drug or substance abuse

Treatment and study plan

NGF injection

Biological

single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm

Primary outcomes

  1. Changes in activation of the pain processing and resting state networks

    Time frame: baseline to one week

    Activation of the resting state network (using functional magnetic resonance imaging (fMRI) and a standard echo planar imaging (EPI) sequence) as well as acitvation of the pain processing network (using fMRI and a standard EPI sequence) in response to painful stimulation, will be measured before and after injection of NGF into the volar forearm of the participant.

    Particants are measured 0-4 days before injection (baseline) and then again 4-7 days after injection (to measure changes due to NGF injection).

Secondary outcomes

  1. Changes in pain intensity, unpleasentness and suffering ratings

    Time frame: baseline to one week

    Pain will be applied by using impact stimulation to the side where NGF was injected as well as a control side. Pain and tolerance thresholds as well as 3 ratings of intensity/unpleasantness and suffering will be obtained immediately after stimulation.

    This will take place before NGF injection (baseline, 0-4 days) and after NGF injection (4-7 days).

    Ratings will be conducted on visual analog scale from 0 (no pain/unpleasantess/suffering) to 100 (worst pain/unpleasantness/suffering imaginable).

Sponsors and collaborators

Lead sponsor

Prof Herta Flor

Other

Collaborators

  • Heidelberg University

Registry information

Official study title

Cortical Representation of NGF-induced Hyperalgesia

Acronym: LOGIN_NGF

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2014
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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