Neuropsychological Assessments for Trigeminal Neuralgia

Overseen By Patcharaporn Srisaikaew, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Opioids, Steroids, Psychoactive drugs

Disqualifiers: Chronic pain, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how chronic pain affects the brain, particularly in areas related to memory and emotions. Researchers aim to observe brain changes in individuals with trigeminal neuralgia, a type of intense facial pain, before and after surgery. They will use brain scans and memory tests to compare results with those of healthy individuals. This trial is suitable for individuals with trigeminal neuralgia who have experienced pain for over six months and are on stable medication. As an unphased trial, participants can contribute to groundbreaking research that may enhance the understanding and treatment of chronic pain.

Will I have to stop taking my current medications?

The trial requires that participants with trigeminal neuralgia have stable medication use, so you may not need to stop your current medications if they are stable. However, if you are using psychoactive medications, you may not be eligible to participate.

What prior data suggests that these imaging and assessment techniques are safe?

Research has shown that MRI scans (a type of brain scan) are generally safe for people with trigeminal neuralgia, a condition causing severe facial pain. Studies indicate that MRIs can identify structural problems in about 15% of these patients, aiding doctors in determining the best treatment. No major safety concerns have been reported for undergoing an MRI.

Similarly, neuropsychological tests (which assess memory and emotions) are well-tolerated. These tests are crucial for understanding how trigeminal neuralgia affects mental health. Research has found that people with this condition often experience higher levels of anxiety and stress. However, the tests themselves are safe and pose no risk to participants.

Both MRI scans and neuropsychological tests have been used safely in many previous studies. Participants in this trial can feel confident about the safety of these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how emotion and memory interact in people with chronic neuropathic pain, specifically trigeminal neuralgia. Unlike traditional treatments that primarily focus on pain relief, this study uses advanced brain imaging and neuropsychological assessments to explore potential cognitive and emotional factors involved in pain perception and management. By examining these elements, the study could lead to new insights and approaches for treating chronic pain, going beyond just addressing the physical symptoms.

What evidence suggests that MR Imaging and Neuropsychological assessments are effective for understanding chronic pain and emotion-memory processes?

This trial will compare brain imaging and cognitive data between healthy controls and patients with trigeminal neuralgia. Studies have shown that MRI scans effectively detect issues like nerve pressure in individuals with trigeminal neuralgia, a condition causing facial pain. The accuracy of MRI for this condition ranges from 94-97%, reliably identifying brain issues related to the pain. Additionally, research has found that individuals with trigeminal neuralgia often experience higher levels of anxiety and depression. These neuropsychological assessments clarify how the condition affects emotions and thinking. Together, MRIs and mental health assessments provide a comprehensive view of both the physical and emotional effects of trigeminal neuralgia, aiding doctors in making better diagnoses and treatment plans. ^{6 7 8 9 10}

Who Is on the Research Team?

Mojgan Hodaie, MD, MSc

Principal Investigator

Department of Neurosurgery, Toronto Western Hospital, University Health Network

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 35 and 60 years old.

I can safely undergo an MRI scan.

I can communicate well enough to complete tasks and questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Assessment

Participants undergo MRI scans and neuropsychological assessments to establish baseline data

1 week

1 visit (in-person)

Surgical Treatment

Participants receive surgical treatment for trigeminal neuralgia

1 day

1 visit (in-person)

Post-Surgical Follow-up

Participants are monitored for changes in brain structure and cognitive function post-surgery

6 months

2 visits (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes and changes in pain perception and cognitive function

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MR Imaging
• Neuropsychological assessments

How Is the Trial Designed?

Group I: Trigeminal Neuralgia Experimental Treatment 2 Interventions

Trigeminal Neuralgia is the most common chronic neuropathic facial pain disorder, characterized by the sudden onset of intermittent, intense, shock-like pain in distributions of the trigeminal nerve branches. TN has several unique features that distinguish it as an ideal model for the study of chronic pain: TN is largely unilateral; is severe in its nature; has stereotypical presentation among patients; and is not associated with other sensory deficits observed in other chronic pain disorders, such as numbness. Brain imaging, clinical data, and cognitive data will be prospectively collect and analyze in both healthy control and patients with trigeminal neuralgia groups. Prospective data collection for TN group includes: * MRI scan (2 timepoints; pre- and 6-month post-surgery) * Neuropsychological assessments (2 timepoints; pre- and 6-month post-surgery)

Group II: Healthy Controls Experimental Treatment 2 Interventions

Brain imaging, clinical data, and cognitive data will be prospectively collect and analyze in both healthy control and patients with trigeminal neuralgia groups. Prospective data collection for control group includes: * MRI scan (1 timepoint) * Neuropsychological assessments (1 timepoint)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39614218/

Predictive value of MRI for identifying symptomatic ... This study aimed to evaluate the effectiveness of MRI in detecting the neurovascular compression that causes symptoms in individuals with classic trigeminal ...

2. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03977-6

Predictive value of MRI for identifying symptomatic ... This study aimed to evaluate the effectiveness of MRI in detecting the neurovascular compression that causes symptoms in individuals with classic trigeminal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846722002840

The practical limits of high-quality magnetic resonance ... Magnetic resonance imaging provides substantial insight into trigeminal neuralgia especially through improved sensitivity of identifying secondary ...

4. ajronline.org ajronline.org/doi/10.2214/AJR.14.14156

MRI of the Trigeminal Nerve in Patients With ... - AJR Online The sensitivity of MRI for the detection of vascular compression of the trigeminal nerve is high, with rates of 94–97% reported in the recent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4052001/

Trigeminal neuralgia treatment outcomes following Gamma ... The incidence of early pain relief was high (80.5 %) in our series. Pain relief was noted an average of 1.6 months after treatment. This time frame is ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26519891/

Microvascular decompression and MRI findings in ... All patients with HS responded to MVD between 25 and 100%, with a mean of 75 ± 22%. Wound complications occurred in 10% of patients with MVD for TIC, and 1 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425014262

Evaluating the diagnostic role of magnetic resonance ... Evaluating the diagnostic role of magnetic resonance imaging in trigeminal neuralgia, hemifacial spasm, and glossopharyngeal neuralgia: A controlled blinded ...

8. neurology.org neurology.org/doi/10.1212/01.wnl.0000326598.83183.04

The diagnostic evaluation and treatment of trigeminal ... Conclusions: In patients with trigeminal neuralgia (TN), routine head imaging identifies structural causes in up to 15% of patients and may be considered useful ...

9. ajnr.org ajnr.org/content/30/3/603

Severity Analysis of Neurovascular Contact in Patients with ... The severity of the NVC was classified as none, simple, moderate, or severe, according to the nerve circumference in contact with the vessel.

10. thejns.org thejns.org/view/journals/j-neurosurg/143/1/article-p74.xml

a resting-state fMRI and machine learning study in Increasing evidence suggests that primary trigeminal neuralgia (TN), including classical TN (CTN) and idiopathic TN (ITN), share biological, ...