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Emotion and Memory in Chronic Neuropathic Pain

N/A

Recruiting

Led By Mojgan Hodaie, MD, MSc

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for hc > recalled pain at baselines. for tn >> recalled pain at baseline (pre-surgery) and at 2 weeks and 6-month post-surgery

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Orofacial Pain
Trigeminal Neuralgia
Facial Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for hc > recalled pain at baselines. for tn >> recalled pain at baseline (pre-surgery) and at 2 weeks and 6-month post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for hc > recalled pain at baselines. for tn >> recalled pain at baseline (pre-surgery) and at 2 weeks and 6-month post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and for hc > recalled pain at baselines. for tn >> recalled pain at baseline (pre-surgery) and at 2 weeks and 6-month post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety Sensitivity Index

Beck Depression Inventory

Beck's Hopelessness Scale

+11 more

Secondary study objectives

Impact of COVID-19 on pain population

Sex- and gender-based analysis (SGBA)

Structural Magnetic Resonance Imaging Cont.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Trigeminal NeuralgiaExperimental Treatment2 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 ControlsExperimental Treatment2 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuropsychological assessments

2009

N/A

~210

MR Imaging

2017

N/A

~60