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Neurophysiologic Signatures of Trigeminal Neuralgia Pain

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ClinicalTrials.gov Identifier: NCT03778177
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Facial Pain Research Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Trigeminal neuralgia (TN) is an idiopathic pain disorder that is characterized by episodic attacks of intense facial pain, described as paroxysms of stabbing, electric, or explosive pain, and lasting for a few seconds or longer, often producing a tic-like facial movement, and can occur up to hundreds of times per day. This pain is known to be one of the worst pain conditions that a patient can suffer and has been called the "suicide disease". Given the severity of this disorder, determining the cause becomes essential for finding a cure. This project will study the cause of TN using a translational approach, which means the research project will be completed in both humans and animals. The investigators hypothesize that there are specific areas of the brain and spinal cord that will provide a "signature" center of activity. The study team will use state of the art magnetic resonance imaging (MRI) machines and other non-invasive brain activity measurements, including electroencephalography (EEG) to locate these centers in people with TN before and after their pain has started. Recent studies have investigated the effects of transcranial electrical stimulation (tES) for pain control. Transcranial electrical stimulation (tES) includes transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS). This approach is important because identifying similar regions neural activity will allow for us to study novel therapies in search of the cure for TN and this study has thus both basic and clinical neuroscience significance.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia (TN) Procedure: transcranial electrical brain stimulation Not Applicable

Detailed Description:

Trigeminal neuralgia (TN) is an extremely painful and highly disabling orofacial pain disorder, often referred to as the "suicide disease," for which presently available therapies are largely ineffective or inadequate. Both the unpredictable response to treatment and variability in long-term clinical outcomes in TN strongly suggest that a range of peripheral and central mechanisms remain to be understood. The long-term goal is to identify the mechanisms involved in the initiation and progression of TN, and uncover rational targets for the safe and effective treatment of TN. The objective of this application is to explore the use of multimodal neuroimaging and neurophysiologic techniques in defining neural signatures of the disease. Additionally, the study team wants to evaluate the efficacy of transcranial electrical stimulation on relieving pain. The rationale for the proposed research is that identification of signature peripheral and central activation sites will allow for individualized treatment strategies for TN patients.

To modulate brain activities the investigators will use transcranial electrical stimulation (tES). tES is an emerging neuromodulation technique that can be noninvasively and safely applied in humans. tES can help better understand the causal roles of brain networks and brain activities and has shown efficacy in improving pain. tES has two main variations: transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS). The former applies a weak direct current to the scalp whereas the latter applies a weak sinusoidal current to the scalp. tDCS can modulate the excitability of tissues under the stimulating electrodes. tACS is particularly suited for interacting with various oscillatory activities in the brain. tES has been used to study normal brain function and treat neurological and pain disorders as well. There is demonstrated efficacy in improvement of pain in subjects suffering from fibromyalgia and neuropathic pain. The study team will use different tDCS/tACS montages targeting different brain regions and observe behavior and neuronal activities. The current strength will be within 1mA or 2mA which has been shown to be safe and effective.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The investigators will use of transcranial electrical stimulation (tES) to evaluate pain in patients with Trigeminal Neuralgia (TN).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mapping Towards a Cure - Identification of Neurophysiologic Signatures of Trigeminal Neuralgia Pain
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trigeminal Neuralgia Pain Diagnosis
Healthy patients between the ages of 18-75 who have been diagnosed with moderate to severe Trigeminal Neuralgia Pain. The study team will perform transcranial electrical brain stimulation using either electrodes that are in the form of two salt-water soaked sponges attached to the head or a set of smaller gel-covered disk electrodes that fit inside the electrode holders of the EEG cap. During stimulation a weak direct or alternating current will be passed through the stimulating electrodes. Stimulation may last 20 to 30 minutes.
Procedure: transcranial electrical brain stimulation
Pain ratings will be recorded before and after transcranial brain electrical stimulation procedures using a Visual Analog Scale (VAS).
Other Name: tES




Primary Outcome Measures :
  1. Effects of transcranial electrical stimulating (tES) on pain. [ Time Frame: Day 1 ]
    Pain will be measured by subjects using a visual analog scale (VAS). The VAS is a psychometric measuring instrument presented as a 100-mm horizontal line anchored on one end with the words "no pain at all" which is 0 and at the other end with the words "worst pain imaginable" which is 100. Subjects will be asked to rate their pain on the VAS from 0-100 once before the stimulation and again after the stimulation is complete. The two scores will be compared to see if there is any reduction in subject's pain after the stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects who have been diagnosed with trigeminal neuralgia (TN) pain (ASA status 1, 2, or 3).
  • Subjects diagnosed with TN pain must have average pain in the moderate to severe (Visual Analog Scale (VAS) of 30-100 mm) range. These subjects will be asked to stop their current medications for 24 hours prior to their scan.
  • Patients diagnosed with classical trigeminal neuralgia, type 1 [TN1, G50.00], or symptomatic trigeminal neuralgia [TN2, G53.80] according to the International Classification of Headache (IHS) Disorders criteria (7).

Exclusion Criteria:

  • Patients diagnosed with post-herpetic neuralgia, trigeminal neuropathic pain, and trigeminal deafferentation pain.
  • TN subjects with ASA status 4-5 and Emergency operation.
  • Presence of chronic disease (e.g. cardiovascular disease, liver disease, kidney disease, diabetes, etc.), other than trigeminal neuralgia.
  • Pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778177


Contacts
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Contact: Janice R Braddy, BS, CCRC 352-273-6669 jbraddy@dental.ufl.edu
Contact: John K Neubert, DDS, PhD 352-273-5687 jneubert@dental.ufl.edu

Locations
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United States, Florida
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
McKnight Brain Institute Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Facial Pain Research Foundation
Investigators
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Principal Investigator: John K Neubert, DDS, MS University of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03778177    
Other Study ID Numbers: TNP001
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
transcranial electrical stimulation (tES)
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Trigeminal Nerve Diseases
Facial Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases