Clinical trial NCT03003715: Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
Official title: Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuropathic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Patient 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);

Patient 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)

Primary outcomes:
measure: Change in MOR BPND levels
timeFrame: place weeks after not more than 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alexandre F DaSilva, DMedSci
role: PRINCIPAL_INVESTIGATOR
References: