Neuralgia PeripheralNCT04106011
Cognitive Changes With Gabapentin Treatment
An observational study of Neuralgia Peripheral and Pain, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuralgia Peripheral, Pain
- What is being tested?
- Gabapentin, BTACT and BPI
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 18 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with neuropathic pain, who are prescribed gabapentin per standard of care
Who may be able to join
- Age between 18 and 85
- Diagnosis of neuropathic pain
- Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
- Able and willing to sign an IRB-approved written informed consent
Who cannot join
- Current pregabalin treatment
- Patient has started taking a new pain medication, or has changed their pain medication dose, in the past 4 weeks.
- Treatment with opioids exceeding 60mg MME.
- Severe cognitive impairment that is documented in medical chart.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical Center/Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain
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.
- Conditions
- Neuralgia Peripheral, Pain
- Being tested
- Gabapentin, BTACT, BPI, HADS, SLP9
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
HADSDiagnostic test
Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale
SLP9Diagnostic test
Assessment of Sleep
NPSIDiagnostic test
Assessment of neuropathic components
| Study group | Role | What they receive |
|---|---|---|
| Patients with Neuropathic Pain | Not described Receives: Drug: Gabapentin; Diagnostic Test: BTACT; Diagnostic Test: BPI; Diagnostic Test: HADS; Diagnostic Test: SLP9; Diagnostic Test: NPSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 6 weeks after treatment initiation
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: up to 6 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Jan 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Why it stopped: PI request - low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuralgia PeripheralStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Justmann, Washington University School of Medicine
- Investigators
- Jessica Justmann, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106011
- Sponsor's protocol ID
- 201908050
- Status last verified
- Feb 2021
- First submitted
- 24 Sep 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 22394606Finnerup 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.
PubMed 26067119Fleet 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.
PubMed 29538407
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain
- ClinicalTrials.gov ID
- NCT04106011
- Acronym / sponsor ID
- 201908050
- Conditions
- Neuralgia Peripheral, Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI request - low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Neuropathic Pain | – | Drug: Gabapentin, Diagnostic Test: BTACT, Diagnostic Test: BPI, Diagnostic Test: HADS, Diagnostic Test: SLP9, Diagnostic Test: NPSI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with neuropathic pain, who are prescribed gabapentin per standard of care
Key inclusion criteria (4 listed)
- Age between 18 and 85
- Diagnosis of neuropathic pain
- Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
- Able and willing to sign an IRB-approved written informed consent
Key exclusion criteria (4 listed)
- Current pregabalin treatment
- Patient has started taking a new pain medication, or has changed their pain medication dose, in the past 4 weeks.
- Treatment with opioids exceeding 60mg MME.
- Severe cognitive impairment that is documented in medical chart.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinTitration 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). | Drug | Patients with Neuropathic Pain |
| BTACTCognition measure: Brief Test of Adult Cognition by Telephone | Diagnostic test | Patients with Neuropathic Pain |
| BPIPain severity and interference at baseline using the Brief Pain Inventory | Diagnostic test | Patients with Neuropathic Pain |
| HADSAssessment of depression and anxiety with the Hospital Anxiety and Depression Scale | Diagnostic test | Patients with Neuropathic Pain |
| SLP9Assessment of Sleep | Diagnostic test | Patients with Neuropathic Pain |
| NPSIAssessment of neuropathic components | Diagnostic test | Patients with Neuropathic Pain |
Primary outcome
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)
4 secondary outcomes
Change in pain severity - BPI
Time frame: up to 6 weeks after treatment initiation
Change in Depression and Anxiety - HADS
Time frame: up to 6 weeks after treatment initiation
Change in Sleep Problems - SLP9
Time frame: up to 6 weeks after treatment initiation
Change in Neuropathic Pain - NPSI
Time frame: up to 6 weeks after treatment initiation
Results and safety
The study was stopped early (reason given: PI request - low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 22394606Berger 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.
- Background: PubMed 26067119Finnerup 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.
- Background: PubMed 29538407Fleet 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.
Related trials for Neuralgia Peripheral
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Justmann, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia Peripheral and Pain, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI request - low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Brief Test of Adult Cognition by Telephone (BTACT) (time frame: up to 6 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106011, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.