Cognitive Changes With Gabapentin Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-02-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuralgia Peripheral Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Neuropathic Pain

Gabapentin

Intervention Type DRUG

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).

BTACT

Intervention Type DIAGNOSTIC_TEST

Cognition measure: Brief Test of Adult Cognition by Telephone

BPI

Intervention Type DIAGNOSTIC_TEST

Pain severity and interference at baseline using the Brief Pain Inventory

HADS

Intervention Type DIAGNOSTIC_TEST

Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale

SLP9

Intervention Type DIAGNOSTIC_TEST

Assessment of Sleep

NPSI

Intervention Type DIAGNOSTIC_TEST

Assessment of neuropathic components

Interventions

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Gabapentin

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).

Intervention Type DRUG

BTACT

Cognition measure: Brief Test of Adult Cognition by Telephone

Intervention Type DIAGNOSTIC_TEST

BPI

Pain severity and interference at baseline using the Brief Pain Inventory

Intervention Type DIAGNOSTIC_TEST

HADS

Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale

Intervention Type DIAGNOSTIC_TEST

SLP9

Assessment of Sleep

Intervention Type DIAGNOSTIC_TEST

NPSI

Assessment of neuropathic components

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No