NCT00713024

Brief Summary

Patients with neuropathic pain exhibit hyperalgesia and allodynia. 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 innocuous and noxious thermal stimulation applied to the distal leg, foot dorsum or forearm between patients with peripheral neuropathy and healthy controls. Functional magnetic resonance imaging will be used to define brain activation to somatic stimulation with noxious and innocuous stimuli. The blood-oxygenation-level-dependent signals will be correlated with visual analogue scale scores and sensory and affective components obtained from the Short-Form McGill Pain Questionnaire. 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 (i.e. spontaneous ongoing pain, paroxysmal pain, allodynia, hyperalgesia) 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

2.9 years

First QC Date

July 9, 2008

Last Update Submit

June 28, 2010

Conditions

Keywords

Pain; Functional neuroimaging; Neuropathy; Thermal sensation

Study Arms (2)

1

Healthy control subjects

2

Patients having neuropathic pain

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit healthy control subjects and patients having neuropathic pain in the current study.

You may qualify if:

  • patients having neuropathic pain
  • healthy control subjects

You may not qualify if:

  • subjects with pacemaker implantation
  • patients with neuropsychiatric disorder except neuropathic pain
  • subjects with agoraphobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

NeuralgiaPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sung-Tsang Hsieh, MD, PhD

    Department of Neurology, National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Sung-Tsang Hsieh, M.D., PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations