Taking peopleNo phase

Brain imaging and memory tests in trigeminal neuralgia facial pain

Looks at brain scans and memory in people with trigeminal neuralgia.

Key facts

Who runs it: University Health Network, Toronto
Where: Canada1 site in 1 countryChoose a country to see its sites
Trial code: NCT06518421
Registry title: Emotion and Memory in Chronic Neuropathic Pain
Status: Recruiting
People taking part: 400 people, planned
Started: 12 Feb 2024
Expected to end: 12 Feb 2029
Type of study: Observational, 2 groups
Treatments tested: Neuropsychological assessments
MR Imaging
Record updated: 24 July 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with trigeminal neuralgia, a severe facial nerve pain, who will have surgery for it. It also takes healthy volunteers of similar age and sex for comparison.

Age: 35 to 60 years
Sex: All sexes
Disease stage: Trigeminal neuralgia (TN) pain for 6 months, meeting the ICHD-3 diagnostic criteria. Healthy volunteers can also join.
Earlier treatment: People with TN must be on stable medication. Chronic use of opioids or steroids is not allowed. Current use of medicines that act on the mind is not allowed.
Biomarker or test result: Memory and thinking test score (MoCA) greater than 23/30.

Main reasons for not taking part

Other chronic pain or headache conditions
Untreated high blood pressure or diabetes
Past drug or substance use disorder, or head injury affecting thinking
Past or current active psychiatric illness, or other active major neurological disorders
Multiple sclerosis, skull base injury or tumours, or being unable to have an MRI scan

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 35 and 60 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

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)
Treatment: Neuropsychological assessments and MR Imaging
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)
Treatment: Neuropsychological assessments and MR Imaging