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Cognitive Changes With Gabapentin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106011
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica Justmann, 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.

Condition or disease Intervention/treatment
Neuralgia Peripheral Pain Drug: Gabapentin Diagnostic Test: BTACT Diagnostic Test: BPI Diagnostic Test: HADS Diagnostic Test: SLP9 Diagnostic Test: NPSI

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Neuropathic Pain Drug: 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).

Diagnostic Test: BTACT
Cognition measure: Brief Test of Adult Cognition by Telephone

Diagnostic Test: BPI
Pain severity and interference at baseline using the Brief Pain Inventory

Diagnostic Test: HADS
Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale

Diagnostic Test: SLP9
Assessment of Sleep

Diagnostic Test: NPSI
Assessment of neuropathic components




Primary Outcome Measures :
  1. Change in the Brief Test of Adult Cognition by Telephone (BTACT) [ Time Frame: 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 :
  1. Change in pain severity - BPI [ Time Frame: 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)

  2. Change in Depression and Anxiety - HADS [ Time Frame: 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)


  3. Change in Sleep Problems - SLP9 [ Time Frame: 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.


  4. Change in Neuropathic Pain - NPSI [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with neuropathic pain, who are prescribed gabapentin per standard of care
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106011


Contacts
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Contact: Carrie Burk 314-273-1807 carrieburk@wustl.edu

Locations
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United States, Missouri
Washington University Medical Center/Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Carrie Burk    314-273-1807    carrieburk@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jessica Justmann, MD Washington University School of Medicine
Publications:
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Responsible Party: Jessica Justmann, Instructor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04106011    
Other Study ID Numbers: 201908050
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents