Neurophysiologic Signatures of Trigeminal Neuralgia Pain
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|ClinicalTrials.gov Identifier: NCT03778177|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : August 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia (TN)||Procedure: transcranial electrical brain stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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 :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
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
- 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.
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
|United States, Florida|
|UF Health Shands Hospital|
|Gainesville, Florida, United States, 32610|
|McKnight Brain Institute|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||John K Neubert, DDS, MS||University of Florida|