Cognitive Changes With Gabapentin Treatment

Terminated

• Conditions: Neuralgia Peripheral; Pain
• Interventions: Drug: Gabapentin; Diagnostic Test: BTACT; Diagnostic Test: BPI; Diagnostic Test: HADS; Diagnostic Test: SLP9; Diagnostic Test: NPSI

• Registration Number: NCT04106011
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2020-01-10
• Status Verified: 2021-02
• Primary Completion: 2021-02-18
• Study Completion: 2021-02-18
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Neuropathic Pain	BTACT	-
Patients with Neuropathic Pain	BPI	-
Patients with Neuropathic Pain	HADS	-
Patients with Neuropathic Pain	NPSI	-
Patients with Neuropathic Pain	SLP9	-
Patients with Neuropathic Pain	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Washington University Medical Center/Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States