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Clinical Trials/NCT03003715
NCT03003715
Completed
Not Applicable

Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain

University of Michigan1 site in 1 country13 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trigeminal Neuropathic Pain
Sponsor
University of Michigan
Enrollment
13
Locations
1
Primary Endpoint
Change in MOR BPND levels
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The main goal of this study to integrate techniques producing images of the brain (also called neuroimaging techniques) with non-invasive brain stimulation to investigate factors that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).

Detailed Description

Trigeminal neuropathic pain (TNP) disorders, such as classical trigeminal and post-surgical neuralgia, are debilitating chronic conditions with pain that is either spontaneous or that can be intensely evoked by light touch to the facial skin. Although neuroimaging techniques have provided insights into some brain mechanisms of experimental trigeminal pain in humans (DaSilva et al., 2002; Borsook et al., 2003), it is not well understood how structural and molecular mechanisms are affected during the course of TNP, and how they can be safely modulated for therapeutic and research purposes. Understanding these processes is crucial to determine the structures engaged in the development and persistence of TNP. We will test the hypothesis that chronicity of TNP is sustained by changes at cellular and molecular levels in neural circuits associated with pain perception and modulation, rather than by the initial peripheral etiology, and that this dysfunction can be safely targeted and modulated as a therapeutic approach by transcranial direct current stimulation (tDCS). To achieve this goal we will use a neuroimaging technique, PET, employing a mathematical model that permits the quantification of opioid receptor availability in vivo.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
December 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandre DaSilva, DDS, MS

DDS, D.Med.Sc.

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Daily chronic TNP for at least 6 months not adequately controlled by pervious medicine therapies;
  • minimal average baseline pain score of 4 (moderate to severe) in the visual analogue scale (VAS);
  • unilateral pain
  • orofacial allodynic region to mechanical (light touch or palpation) or thermal stimulation (head or cold);

Exclusion Criteria

  • pregnancy or planning to become pregnant
  • local pathology (e.g. orofacial lesion)
  • history of systemic disorders (e.g. MS)
  • history of other chronic pain disorder (e.g. back pain)
  • recent orofacial surgery or trauma (\< 6 months)
  • history of central origin disorders (e.g. stroke)

Outcomes

Primary Outcomes

Change in MOR BPND levels

Time Frame: place weeks after not more than 6months

change from baseline to versus sham or active tDCS

Study Sites (1)

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