Emotion and Memory in Chronic Neuropathic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-60
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
* Healthy control will be recruited from the local community * Patients with Trigeminal neuralgia will be recruited through our Neurosurgery and Pain Clinic at Toronto Western Hospital, University Health Network
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neuropsychological assessments
Behavioral* 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
Diagnostic testMagnetic 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Healthy Controls2 interventions
Group B: Trigeminal Neuralgia2 interventions
Trial outcomes
Primary outcomes
1
Beck Depression Inventory
The Beck Depression Inventory (BDI) will be included in our battery of neuropsychological assessments that will be conducted on both HC and TN groups to screen for study inclusion and exclusion criteria. The BDI consists of 21 questions on which patients must score themselves on a scale from zero to three. The BDI is scored out of 63 with a score over 31 representing severe depression.
Time frame
For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria2
Behavioural Inhibition System
The Behavioural Inhibition System (BIS) will be included in our battery of neuropsychological assessments that will be conducted on both HC and TN groups to screen for study inclusion and exclusion criteria. The BIS is a 20 question, self-assessment that measures trait sensitivity levels of the behavioral inhibition and activation systems.
Time frame
For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria3
Anxiety Sensitivity Index
The Anxiety Sensitivity Index (ASI) will be included in our battery of neuropsychological assessments that will be conducted on both HC and TN groups to screen for study inclusion and exclusion criteria. The ASI is a six item scale that can outline different concerns someone could have regarding their anxiety.
Time frame
For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteria4
Beck's Hopelessness Scale
The Beck Hopelessness Scale (BHS) will be included in our battery of neuropsychological assessments that will be conducted on both HC and TN groups to screen for study inclusion and exclusion criteria.
Time frame
For HC and TN > Neuropsychological assessments at baseline to screen for inclusion/exclusion criteriaSecondary outcomes
1
Structural Magnetic Resonance Imaging Cont.
Group correlation between other AMG nuclei volumes and pain-related fear and anxiety questionnaires will be performed. The investigators will assess whether the abnormalities of other AMG nuclei volumes will be normalized after surgery and/or correlated with the validated pain-related fear and anxiety assessments.
Time frame
For HC > MRI at baseline. For TN > MRI at baseline (pre-surgery) and at 6-month post-surgical)2
The Rey Auditory Verbal Learning Test (RAVLT)
Group correlation between other HPC subfield volumes and a second HPC-specific memory task using the Rey Auditory Verbal Learning Test (RAVLT) will be performed to evaluate multiple episodic memory functions in both inter-group (TN vs. HC) and intra-group (pre- vs. post-surgery).
Time frame
For HC > RAVLT at baseline. For TN > RAVLT at baseline (pre-surgery) and at 6-month post-surgical)3
Whole brain cortical-based analysis
Group comparisons of other limbic structures will be performed, using the whole brain cortical-based analysis with a focus on the thickness of the anterior cingulate (ACC), insular, and medial prefrontal cortex (mPFC) cortices. The investigator will be focused on the dynamic changes of the cortical thickness in TN between i) TN vs. HC, and ii) pre- vs. post-surgical time points.
Time frame
For HC > MRI at baseline. For TN > MRI at baseline (pre-surgery) and at 6-month post-surgical)4
Impact of COVID-19 on pain population
Medical and medication history including COVID-19-related experiences will be collected. The investigator will also address the biopsychological impacts of COVID-19 in our study cohort.
Time frame
For HC > COVID-19 related data at baseline. For TN > COVID-19 related data at baseline (pre-surgery) and at 6-month post-surgical)Sponsors and contacts
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Source ClinicalTrials.gov