Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Refractory Trigeminal Neurpathic Pain (TNP) Patients
All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
|
Two 90 minute scans whose maximum radiological dose is 15 mCi [11 C] carfentanil, a selective and specific mu-opioid receptor radioligand.
The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.
|
|
Experimental: Healthy volunteers
All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
|
Two 90 minute scans whose maximum radiological dose is 15 mCi [11 C] carfentanil, a selective and specific mu-opioid receptor radioligand.
The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in MOR BPND levels
Time Frame: place weeks after not more than 6months
|
change from baseline to versus sham or active tDCS
|
place weeks after not more than 6months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandre F DaSilva, DMedSci, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00024607
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