Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor

Not Applicable

Completed

• Conditions: Non-inflammatory Neuropathic Pain; Healthy Subjects
• Interventions: Biological: NGF injection

• Registration Number: NCT02159170
• Lead Sponsor: Prof Herta Flor

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NGF	NGF injection	injection of 50 µl NGF, once into the left volar forearm and injection of 50 µl NaCl (sodium chloride) once into the right volar forearm

Primary Outcome Measures

Name	Time	Method
Changes in activation of the pain processing and resting state networks	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 Outcome Measures

Name	Time	Method
Changes in pain intensity, unpleasentness and suffering ratings	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).

Trial Locations

Locations (1)

Central Institute of Mental Health; 🇩🇪 Mannheim, Germany