Neuralgia Peripheral, Pain
Conditions
Brief summary
This is a single-cohort, prospective, observational study evaluating the effects of gabapentin on cognition. The goal of the study is to determine whether there is a measurable change in cognitive function from baseline in patients who are prescribed gabapentin for the treatment of neuropathic pain.
Interventions
DRUGGabapentin
Titration of gabapentin will be standardized as 300mg QHS and increased by 300mg every 3 days until taking 1200mg TID or maximum tolerable dose. Subjects will undergo cognitive evaluation prior to initiation of the medication, at 1 week (when titrated to approximately 900mg/day), 3 weeks (when titrated to approximately 2100mg/day), and at 6 weeks (when titrated to 3600mg/day or maximum tolerable dose).
DIAGNOSTIC_TESTBTACT
Cognition measure: Brief Test of Adult Cognition by Telephone
DIAGNOSTIC_TESTBPI
Pain severity and interference at baseline using the Brief Pain Inventory
DIAGNOSTIC_TESTHADS
Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale
DIAGNOSTIC_TESTSLP9
Assessment of Sleep
DIAGNOSTIC_TESTNPSI
Assessment of neuropathic components
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
1. Age between 18 and 85 2. Diagnosis of neuropathic pain 3. Patient report of average daily pain intensity in the last week \>3 on 0-10 Numerical Rating Scale (NRS). 4. Able and willing to sign an IRB-approved written informed consent
Exclusion criteria
1. Current pregabalin treatment 2. Patient has started taking a new pain medication, or has changed their pain medication dose, in the past 4 weeks. 3. Treatment with opioids exceeding 60mg MME. 4. Severe cognitive impairment that is documented in medical chart.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Brief Test of Adult Cognition by Telephone (BTACT) | up to 6 weeks after treatment initiation | Measure of cognitive functioning that assesses multiple dimensions central for effective functioning across adulthood: episodic memory, working memory, reasoning, verbal fluency, and executive functioning. Scoring: Word List Recall - Immediate & Delayed Total number unique is total number of correct responses (range 0-15) Backward Digit Span Score is highest number of digits reached (range 0, 2-8) Category Fluency Total number unique is total number of correct responses Red/Green Accuracy Normal baseline score is total number correct in normal baseline condition (range 0-20) Number Series Total number of items correct (range 0-5) Backward Counting Last number reached Total number of errors Total number of digits produced is calculated as: 100 - (number reached + number errors) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain severity - BPI | up to 6 weeks after treatment initiation | Medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Center for Symptom Evaluation in Cancer Care 0-10 pain severity scale, 0=no pain, 10=pain as bad as you can imagine (scoring-a mean severity score) 0-10 pain relief scale, 0%=no relief, 100%=complete relief (only one question) 0-10 pain interference scale, 0=does not interfere, 10=completely interferes (scoring-mean of 7 items) |
| Change in Depression and Anxiety - HADS | up to 6 weeks after treatment initiation | Measure of anxiety and depression in a general population of patients. Popular for clinical practice and research. Score- 8-10 mild, 11-14 moderate, 15-21 severe (separate scores for anxiety and depression) |
| Change in Sleep Problems - SLP9 | up to 6 weeks after treatment initiation | Questionnaire to evaluate problems with sleep. Scale: 1=all of the time, 2=most of the time, 3=a good bit of the time, 4=some of the time, 5=a little of the time, 6=none of the time Final scores range from 0-100, with higher scores indicating more sleep problems. To score the SPI II, you must first transform the responses of each item into a new score. For item 1, responses of 1, 2, 3, 4, and 5 are scored as 0, 25, 50, 75, and 100, respectively. For items 3 and 9, ratings of 1 through 6 are scored as 0, 20, 40, 60, 80, and 100, respectively. All of the other items are reverse-scored (lower ratings indicate more sleep difficulties) and so ratings of 1 through 6 for these items are scored as 100, 80, 60, 40, 20, and 0, respectively. The final SPI II score is an average of the item scores responded to. |
| Change in Neuropathic Pain - NPSI | up to 6 weeks after treatment initiation | Questionnaire to evaluate the different symptoms of neuropathic pain. 0-10 scale, 0=no sensation, 10=greatest sensation intensity |
Countries
United States
Outcome results
None listed