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Healthy Controls for Facial 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

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
  • Facial Pain
  • Trigeminal Neuralgia

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
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

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

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
499,805 Total Patients Enrolled
2 Trials studying Facial Pain
3,284 Patients Enrolled for Facial Pain
Mojgan Hodaie, MD, MScPrincipal InvestigatorDepartment of Neurosurgery, Toronto Western Hospital, University Health Network
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Facial Pain
24 Patients Enrolled for Facial Pain
~267 spots leftby Feb 2027
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