Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003715
Other study ID # HUM00024607
Secondary ID
Status Completed
Phase N/A
First received December 22, 2016
Last updated November 21, 2017
Start date September 2011
Est. completion date December 2012

Study information

Verified date November 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Other:
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in MOR BPND levels change from baseline to versus sham or active tDCS place weeks after not more than 6months
See also
  Status Clinical Trial Phase
Terminated NCT02321566 - Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain. Phase 1
Active, not recruiting NCT03309813 - Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain N/A