Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
NCT ID: NCT03003715
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2011-09-30
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
PET Scans
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.
transcranial direct current stimulation (tDCS)
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
MRI
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
sham tDCS (prior to real tDCS)
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.
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.
PET Scans
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.
transcranial direct current stimulation (tDCS)
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
MRI
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
sham tDCS (prior to real tDCS)
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.
Interventions
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PET Scans
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.
transcranial direct current stimulation (tDCS)
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
MRI
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
sham tDCS (prior to real tDCS)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Alexandre DaSilva, DDS, MS
DDS, D.Med.Sc.
Principal Investigators
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Alexandre F DaSilva, DMedSci
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00024607
Identifier Type: -
Identifier Source: org_study_id