Brain Activation During Thermal Stimulation in Neuropathic Pain

September 3, 2007 updated by: National Taiwan University Hospital
Patients with peripheral neuropathy frequently exhibit treatment-refractory neuropathic pain. Although both peripheral and central determinants are recognized for the pathophysiological basis of neuropathic pain following peripheral injury, the modulating effect on pain processing in brain by peripheral mechanisms remains elusive. Here, we will systematically compare the sensory symptoms and brain activation to painful heat stimulation applied to the foot dorsum between patients with peripheral neuropathy and healthy controls. Functional magnetic resonance imaging will be used to define brain activation to thermal stimulation with noxious heat and innocuous warm thermal stimuli applied by contact heat stimulator. Brain activation during thermal stimulation in patients with neuropathic pain will be clarified, and we will also analyze the potential relationships between the topography, quality and intensity of the different painful symptoms and the magnitude and pattern of brain activation during thermal stimulation. This will add in our understanding in the pathophysiology of brain modulation in pain and provide clinically useful message toward the potential therapeutics in the management of neuropathic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

Patients with peripheral neuropathy and healthy volunteers will be recruited in this study. Peripheral neuropathy is defined according to the neuropathic symptoms and signs. Informed consent will be approved by the Ethical Committee of the National Taiwan University Hospital and obtained from each subject.

To assess the severity of different neuropathic symptoms, such as spontaneous ongoing and paroxysmal pain, evoked pain, paraesthesia, and dysaesthesia, patients with neuropathic pain will fill out the Neuropathic Pain Symptom Inventory. Each subject will receive detailed sensory examination to evaluate the integrity of sensory fibers. To measure thresholds of thermal and vibratory sensations, we will perform quantitative sensory testing by the method of level using a Thermal Sensory Analyser and Vibratory Sensory Analyser (Medoc Advanced Medical System, Minneapolis, MN, USA) following an established protocol. We will use a contact heat stimulator to deliver thermal stimulation. Noxious and innocuous heat temperatures will be applied within the right foot dorsum. Several pretests will be applied before CHEP recording to eliminate expectation effects. To avoid sensitization and desensitization, low intensity stimuli will precede high intensity stimuli at each block.

Functional magnetic resonance imaging (fMRI) will be performed on a 3-T MR machine (Sonata; Siemens, Erlangen, Germany). A high resolution T1 weighted scan of the entire brain in trans-axial orientation will be obtained to provide anatomical information for the superimposed functional activation maps. Echo Planar Imaging will be used for the acquisition of the functional data. Each imaging session will be consisted of one high-resolution anatomical scan and three functional scanning runs, with 5-min intersession interval. During the scanning, several thermal stimuli will be applied by CHEP stimulator to the right dorsal foot. To avoid sensitization, the stimulation site will be changed slightly after each stimulus. After 12-s stimulation, the temperature will be cooling, with a subsequent 36-s interstimulus interval. After each fMRI session, subjects will be asked to rate the intensity and unpleasantness of received pain stimulus. The average rating values will be indicated after the scan on a computer driven visual analogue scale ranging from 0 to 10 (0, no pain; 1, slight intense; 2, mild intense; 3, moderate intense; 4, slight pain; 5, mild pain; 6, moderate pain; 7, moderate-strong pain; 8, strong pain; 9, severe pain; 10, unbearable pain), and the intensity and unpleasantness of received pain will be assessed using the Short-Form McGill Pain Questionnaire.

All data will be processed using the Statistical Parametric Mapping software (SPM2). fMRI data series will be realigned and resliced with sinc interpolation to correct for motion artifacts. Scans with sudden head movements of more than 2 mm will be omitted. To enable intersubject analysis, the functional data will be coregistered to the anatomical scan and transformed into a reference space according to the MNI template of SPM2 by normalization using sinc interpolation. The resampled voxel volume of the normalized images is 2 x 2 x 2 mm. Subsequently, data will be smoothed with an isotropic Gaussian kernel of 8 mm full-width at half maximum to reduce high frequency noise and to account for anatomical variances. Condition-specific effects will be estimated with the general linear model using a boxcar approach convolved with the hemodynamic response function. High pass filtering will remove low frequency noise and low pass filtering will account for serial autocorrelations of the data.

We will analyze the data on an individual (subject per subject) basis and across subjects (group analysis) using a cross-subjects variance (random effect analysis). Data from each stimulation will be pooled for group statistical comparisons. A single design matrix, including 3 sessions of all subjects, will be generated due to the limited number of experiments representing a fixed-effects model analysis. Statistical parametric maps will be generated as t-contrasts and corrected for multiple comparisons according to the random field theory with P < 0.05. The threshold for the Z maps is 3.09 (P < 0.001) for individual subject analysis. Significant clusters have to show a minimum extension volume of 10 voxels.

Study Type

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

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80

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with peripheral neuropathy (defined according to the neuropathic symptoms and signs) and healthy volunteers will be recruited in this study

Exclusion Criteria:

  • subjects with structural brain lesions, pacemaker implantation, agoraphobia, and neurotic disorders.

Study Plan

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How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sung-Tsang Hsieh, MD, PhD, Departments of Neurology,National Taiwan University Hospital

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2007

More Information

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9561701022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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