Trigeminal Neuropathic PainNCT03003715
Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
A study testing PET Scans, transcranial direct current stimulation (tDCS) and MRI in people with Trigeminal Neuropathic Pain, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuropathic Pain
- What is being tested?
- PET Scans, transcranial direct current stimulation (tDCS) and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Trigeminal Neuropathic Pain
- Being tested
- PET Scans, transcranial direct current stimulation (tDCS), MRI, sham tDCS (prior to real tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScansProcedure or surgery
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)Procedure or surgery
In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
MRIProcedure or surgery
No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
sham tDCS (prior to real tDCS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Refractory Trigeminal Neurpathic Pain (TNP) Patients | Experimental | 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. Receives: Procedure: PET Scans; Procedure: transcranial direct current stimulation (tDCS); Procedure: MRI; Other: sham tDCS (prior to real tDCS) |
| Healthy volunteers | Experimental | 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. Receives: Procedure: PET Scans; Procedure: transcranial direct current stimulation (tDCS); Procedure: MRI; Other: sham tDCS (prior to real tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MOR BPND levels
change from baseline to versus sham or active tDCS
Measured: place weeks after not more than 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, MS, University of Michigan
- Investigators
- Alexandre F DaSilva, DMedSci, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003715
- Sponsor's protocol ID
- HUM00024607
- Status last verified
- Nov 2017
- First submitted
- 22 Dec 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03003715
- Acronym / sponsor ID
- HUM00024607
- Conditions
- Trigeminal Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refractory Trigeminal Neurpathic Pain (TNP) Patients | Experimental | Procedure: PET Scans, Procedure: transcranial direct current stimulation (tDCS), Procedure: MRI, Other: sham tDCS (prior to real tDCS)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. |
| Healthy volunteers | Experimental | Procedure: PET Scans, Procedure: transcranial direct current stimulation (tDCS), Procedure: MRI, Other: sham tDCS (prior to real tDCS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ScansTwo 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. | Procedure or surgery | Healthy volunteers, Refractory Trigeminal Neurpathic Pain (TNP) Patients |
| transcranial direct current stimulation (tDCS)In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes. | Procedure or surgery | Healthy volunteers, Refractory Trigeminal Neurpathic Pain (TNP) Patients |
| MRINo radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans. | Procedure or surgery | Healthy volunteers, Refractory Trigeminal Neurpathic Pain (TNP) Patients |
| 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. | Other | Healthy volunteers, Refractory Trigeminal Neurpathic Pain (TNP) Patients |
Primary outcome
Change in MOR BPND levels
Time frame: place weeks after not more than 6months
change from baseline to versus sham or active tDCS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre F DaSilva, DMedSci principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Scans, transcranial direct current stimulation (tDCS) and MRI in people with Trigeminal Neuropathic Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MOR BPND levels (time frame: place weeks after not more than 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.