Trigeminal Neuralgia (TN)NCT03778177
Neurophysiologic Signatures of Trigeminal Neuralgia Pain
A study testing transcranial electrical brain stimulation in people with Trigeminal Neuralgia (TN), run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia (TN)
- What is being tested?
- transcranial electrical brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2019to 12 May 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health Shands Hospital
Gainesville, Florida, 32610
McKnight Brain Institute
Gainesville, Florida, 32611
About this study
Official title: Mapping Towards a Cure - Identification of Neurophysiologic Signatures of Trigeminal Neuralgia Pain
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.
Read the 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.
- Conditions
- Trigeminal Neuralgia (TN)
- Being tested
- transcranial electrical brain stimulation
- Keywords
- transcranial electrical stimulation (tES)
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical brain stimulationProcedure or surgery
Also called tES
Pain ratings will be recorded before and after transcranial brain electrical stimulation procedures using a Visual Analog Scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal Neuralgia Pain Diagnosis | Experimental | 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. Receives: Procedure: transcranial electrical brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of transcranial electrical stimulating (tES) on pain.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Feb 2019
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Trigeminal Neuralgia (TN)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will use of transcranial electrical stimulation (tES) to evaluate pain in patients with Trigeminal Neuralgia (TN).
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Facial Pain Research Foundation
- Responsible party
- Sponsor
- Investigators
- John K Neubert, DDS, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778177
- Sponsor's protocol ID
- TNP001
- Status last verified
- Oct 2022
- First submitted
- 11 Dec 2018
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasad S, Galetta S. Trigeminal neuralgia: historical notes and current concepts. Neurologist. 2009 Mar;15(2):87-94. doi: 10.1097/NRL.0b013e3181775ac3.
PubMed 19276786Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.
PubMed 29652088Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.
PubMed 24064065Saltychev M, Laimi K. Effectiveness of repetitive transcranial magnetic stimulation in patients with fibromyalgia: a meta-analysis. Int J Rehabil Res. 2017 Mar;40(1):11-18. doi: 10.1097/MRR.0000000000000207.
PubMed 27977465Lefaucheur JP. The use of repetitive transcranial magnetic stimulation (rTMS) in chronic neuropathic pain. Neurophysiol Clin. 2006 May-Jun;36(3):117-24. doi: 10.1016/j.neucli.2006.08.002. Epub 2006 Aug 23.
PubMed 17046606Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Towards a Cure - Identification of Neurophysiologic Signatures of Trigeminal Neuralgia Pain
- ClinicalTrials.gov ID
- NCT03778177
- Acronym / sponsor ID
- TNP001
- Conditions
- Trigeminal Neuralgia (TN)
- Keywords
- transcranial electrical stimulation (tES)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Facial Pain Research Foundation
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will use of transcranial electrical stimulation (tES) to evaluate pain in patients with Trigeminal Neuralgia (TN).
| Arm | Type | Receives |
|---|---|---|
| Trigeminal Neuralgia Pain Diagnosis | Experimental | Procedure: transcranial electrical brain stimulationHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| transcranial electrical brain stimulationAlso: tESPain ratings will be recorded before and after transcranial brain electrical stimulation procedures using a Visual Analog Scale (VAS). | Procedure or surgery | Trigeminal Neuralgia Pain Diagnosis |
Primary outcome
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.
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 6 Oct 2022.
- Background: PubMed 19276786Prasad S, Galetta S. Trigeminal neuralgia: historical notes and current concepts. Neurologist. 2009 Mar;15(2):87-94. doi: 10.1097/NRL.0b013e3181775ac3.
- Background: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Background: PubMed 29652088O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.
- Background: PubMed 24064065Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.
- Background: PubMed 27977465Saltychev M, Laimi K. Effectiveness of repetitive transcranial magnetic stimulation in patients with fibromyalgia: a meta-analysis. Int J Rehabil Res. 2017 Mar;40(1):11-18. doi: 10.1097/MRR.0000000000000207.
- Background: PubMed 17046606Lefaucheur JP. The use of repetitive transcranial magnetic stimulation (rTMS) in chronic neuropathic pain. Neurophysiol Clin. 2006 May-Jun;36(3):117-24. doi: 10.1016/j.neucli.2006.08.002. Epub 2006 Aug 23.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Individual participant dataSharing planned: No
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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.
John K Neubert, DDS, MS principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical brain stimulation in people with Trigeminal Neuralgia (TN), run by University of Florida at 2 sites 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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effects of transcranial electrical stimulating (tES) on pain. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778177, which also lists 7 linked publications.
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 6 Oct 2022.