Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06518421

Conditions

Trigeminal Neuralgia

Facial Pain

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Accepted

Interventions

Neuropsychological assessments

MR Imaging

Study Details

Brief summary:

Chronic pain affects one in four Canadians, leading to severe personal and societal costs. Over 70% of chronic pain patients report memory difficulties and fear having unexpected pain. Abnormalities in brain structures associated with emotion and memory, including the hippocampus and amygdala, can be affected by chronic pain. Understanding the relationship between chronic pain, structural brain changes, and cognitive functioning will lead to improved diagnosis, treatment, and outcomes in chronic pain disorders. In this project, the investigators will use advanced brain imaging techniques that assess the structure and function of the brain along with cognitive assessments to examine the overlap between chronic pain and emotion-memory processes. The study team will conduct the study using an excellent model of chronic pain-trigeminal neuralgia, a severe form of facial pain that responds well to surgical treatment. Brain images and cognitive data will be collected from participants before and after surgical treatment for pain. This information will be analyzed and compared with age- and sex-matched healthy individuals. This study will be the first to thoroughly investigate relationships between brain structure and function, cognition (memory, emotion), and promises to impact our understanding of chronic neuropathic pain conditions.

Conditions

Trigeminal Neuralgia

Facial Pain

Study ID

NCT06518421

Start date

Feb 12, 2024

Status verified date

Jul, 2024

Completion date

Feb 12, 2029

Anticipated

Primary completion date

Feb 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Accepted

Inclusion Criteria (for HC and TN):

  • Age between 35 and 60 years old
  • Absence of other active major neurological or psychiatric disorders
  • Absence of MRI contraindications
  • Able to communicate sufficiently to complete tasks and questionnaires
  • Montreal Cognitive Assessment (MoCA) score greater than 23/30 (MoCA ≤23/30 could indicate severe cognitive impairment)

Inclusion Criteria for TN:

  • Experiencing TN pain over a period of 6 months
  • Stable medication use
  • Meet established diagnostic criteria for TN (ICHD-3)

Exclusion Criteria (both HC and TN):

  • Presence of other chronic pain/headache conditions
  • Untreated hypertension or diabetes mellitus
  • History of chronic drug or substance use disorder, chronic use of opioids or steroids, head trauma affecting cognitive performance,
  • History/presence of active psychiatric illness and/or current use of psychoactive medication
  • History of multiple sclerosis, skull base injury or tumours

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

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)

Trigeminal Neuralgia

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)

Interventions

Neuropsychological assessments

  • Pain questionnaires such as Numerical Pain Rating Scale is one of the most widely used multidimensional pain scales to assesses a person's pain based on the words they use to describe their pain.
  • Battery of Cognitive questionnaires = The cognitive test battery was designed to assess key cognitive abilities including attention, concentration, verbal learning and memory, verbal fluency, working memory and executive function as well as global cognitive functioning and fear and anxiety
  • Mnemonic Simulation Test and Rey Auditory Verbal Learning Test are the neuropsychological assessments designed to evaluate recognition and verbal memory, respectively. Both tasks have been shown to be very sensitive to hippocampal engagement and damage.
  • Memory-recall interview is an interview for the interviewees to recall the event from different perspectives, such as from the preadmission date, 2-week post- and 6-month post-surgical date. This supports the memory retrieval process.

MR Imaging

Magnetic Resonance Imaging is a noninvasive medical imaging test that produces detailed images of almost every internal structure in the human body, including the organs, bones, muscles and blood vessels. MRI scanners create images of the body using a large magnet and radio waves.

Primary outcome measure

  • Beck Depression Inventory [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Behavioural Inhibition System [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Anxiety Sensitivity Index [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Beck's Hopelessness Scale [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Marlowe Crowne Scale [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Childhood Trauma Questionnaire [ Time Frame: For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria ]
  • Structural magnetic resonance imaging (MRI) [ Time Frame: For HC > MRI at baseline. For TN > MRI at baseline (pre-surgery) and at 6-month post-surgical) ]
  • Mnemonic Similarity Test [ Time Frame: For HC > MRI at baseline. For TN > MRI at baseline (pre-surgery) and at 6-month post-surgical) ]
  • Fear of Pain Questionnaire III [ Time Frame: For HC > pain-related fear and anxiety assessments at baseline. For TN >> pain-related fear and anxiety assessments at baseline (pre-surgery) and at 6-month post-surgical ]
  • Pain Catastrophizing Scale [ Time Frame: For HC > pain-related fear and anxiety assessments at baseline. For TN >> pain-related fear and anxiety assessments at baseline (pre-surgery) and at 6-month post-surgical ]
  • State-Trait Anxiety Inventory [ Time Frame: For HC > pain-related fear and anxiety assessments at baseline. For TN >> pain-related fear and anxiety assessments at baseline (pre-surgery) and at 6-month post-surgical ]
  • Pain Anxiety Symptoms Scale [ Time Frame: For HC > pain-related fear and anxiety assessments at baseline. For TN >> pain-related fear and anxiety assessments at baseline (pre-surgery) and at 6-month post-surgical ]
  • Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: For HC >ES task-fMRI at baseline. For TN >> ES task-based fMRI at baseline (pre-surgery) and 6-months post-surgery ]
  • Recalled pain memory interview [ Time Frame: For HC > recalled pain at baselines. For TN >> recalled pain at baseline (pre-surgery) and at 2 weeks and 6-month post-surgery ]

Central Contacts and Locations

Central contacts

Jacob Kim, BSc

4163404907jacob.kim@uhn.ca

Patcharaporn Srisaikaew, PhD

4163404907patcharaporn.srisaikaew@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Jacob Kim, BSc

4166035800jacob.kim@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 24, 2024

Last verified

Jul, 2024

Keywords

  • Trigeminal Neuralgia
  • Facial Pain
  • Emotion
  • Cognition
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-07-24.