Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor

Healthy Subjects Clinical Trial

— LOGIN_NGF  

Official title:

Cortical Representation of NGF-induced Hyperalgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159170
• Other study ID #: LOGIN_NGF
• Secondary ID: 01ED1010D
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: January 15, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission (Medical Faculty Mannheim, Heidelberg University)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects
• Hyperalgesia
• Neuralgia
• Non-inflammatory Neuropathic Pain

Intervention

Biological:
• NGF injection
single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Prof Herta Flor	Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in activation of the pain processing and resting state networks	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).	baseline to one week	No
Secondary	Changes in pain intensity, unpleasentness and suffering ratings	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).	baseline to one week	No