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PI request - low enrollment
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Neuropathic Pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 6 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with neuropathic pain, who are prescribed gabapentin per standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Justmann, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University Medical Center/Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22394606 | Background | Berger A, Sadosky A, Dukes E, Edelsberg J, Oster G. Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders in UK general practice: a retrospective cohort study. BMC Neurol. 2012 Mar 6;12:8. doi: 10.1186/1471-2377-12-8. | |
| 26067119 | Background | Finnerup NB, Attal N. Tapentadol prolonged release in the treatment of neuropathic pain related to diabetic polyneuropathy--authors' reply. Lancet Neurol. 2015 Jul;14(7):685-6. doi: 10.1016/S1474-4422(15)00060-5. No abstract available. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
| BTACT | Diagnostic Test | Cognition measure: Brief Test of Adult Cognition by Telephone |
|
| BPI | Diagnostic Test | Pain severity and interference at baseline using the Brief Pain Inventory |
|
| HADS | Diagnostic Test | Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale |
|
| SLP9 | Diagnostic Test | Assessment of Sleep |
|
| NPSI | Diagnostic Test | Assessment of neuropathic components |
|
| 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) | 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. | up to 6 weeks after treatment initiation |
| Change in Neuropathic Pain - NPSI | Questionnaire to evaluate the different symptoms of neuropathic pain. 0-10 scale, 0=no sensation, 10=greatest sensation intensity | up to 6 weeks after treatment initiation |
| 29538407 | Background | Fleet JL, Dixon SN, Kuwornu PJ, Dev VK, Montero-Odasso M, Burneo J, Garg AX. Gabapentin dose and the 30-day risk of altered mental status in older adults: A retrospective population-based study. PLoS One. 2018 Mar 14;13(3):e0193134. doi: 10.1371/journal.pone.0193134. eCollection 2018. |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |