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Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain

NCT03003715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-11-24

No results posted yet for this study

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).

Conditions

  • Trigeminal Neuropathic Pain

Interventions

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.

PROCEDURE

transcranial direct current stimulation (tDCS)

In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.

PROCEDURE

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.

Sponsors & Collaborators

Principal Investigators

  • Alexandre F DaSilva, DMedSci · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003715 on ClinicalTrials.gov