Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor (LOGIN_NGF)
Primary Purpose
Non-inflammatory Neuropathic Pain, Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NGF injection
Sponsored by
About this trial
This is an interventional basic science trial for Non-inflammatory Neuropathic Pain focused on measuring Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
Eligibility Criteria
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
Sites / Locations
- Central Institute of Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NGF
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02159170
First Posted
June 3, 2014
Last Updated
January 15, 2015
Sponsor
Prof Herta Flor
Collaborators
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT02159170
Brief Title
Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor
Acronym
LOGIN_NGF
Official Title
Cortical Representation of NGF-induced Hyperalgesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Herta Flor
Collaborators
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-inflammatory Neuropathic Pain, Healthy Subjects
Keywords
Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGF
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
NGF injection
Intervention Description
single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm
Primary Outcome Measure Information:
Title
Changes in activation of the pain processing and resting state networks
Description
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).
Time Frame
baseline to one week
Secondary Outcome Measure Information:
Title
Changes in pain intensity, unpleasentness and suffering ratings
Description
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).
Time Frame
baseline to one week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herta Flor, PhD
Organizational Affiliation
Medical Faculty Mannheim, Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
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Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor
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