Cognitive Changes With Gabapentin Treatment

Washington University School of Medicine3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuralgia Peripheral Pain

Interventions

GabapentinDRUG

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).

BTACTDIAGNOSTIC_TEST

Cognition measure: Brief Test of Adult Cognition by Telephone

BPIDIAGNOSTIC_TEST

Pain severity and interference at baseline using the Brief Pain Inventory

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University Medical Center/Barnes-Jewish Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Change in the Brief Test of Adult Cognition by Telephone (BTACT)

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)

Time frame: up to 6 weeks after treatment initiation

Secondary Outcomes

Change in pain severity - BPI

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)

Time frame: up to 6 weeks after treatment initiation

Change in Depression and Anxiety - HADS

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)

Time frame: up to 6 weeks after treatment initiation

Change in Sleep Problems - SLP9

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.

Data from ClinicalTrials.gov

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