ClinicalTrials.gov

History of Changes for Study: NCT02373449
Ketamine and fMRI for Neuropathic Pain
Latest version (submitted April 26, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 22, 2015 None (earliest Version on record)
2 March 26, 2015 Contacts/Locations and Study Status
3 February 1, 2016 Study Status, IPDSharing and Arms and Interventions
4 October 25, 2016 Contacts/Locations and Study Status
5 April 19, 2017 Study Status and Contacts/Locations
6 June 16, 2017 Contacts/Locations and Study Status
7 July 13, 2017 Study Status and Contacts/Locations
8 January 30, 2018 Study Status
9 March 1, 2019 Study Status
10 March 23, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
11 August 20, 2020 Study Status
12 April 26, 2021 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02373449
Submitted Date:  February 22, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 14-8706-AE
Brief Title: Ketamine and fMRI for Neuropathic Pain
Official Title: Functional Magnetic Resonance Imaging to Predict and Correlate Clinical Outcomes of Ketamine Infusions for Refractory Neuropathic Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Recruiting
Study Start: February 2015
Primary Completion: March 2017 [Anticipated]
Study Completion: October 2017 [Anticipated]
First Submitted: February 9, 2015
First Submitted that
Met QC Criteria:
February 22, 2015
First Posted: February 27, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 22, 2015
Last Update Posted: February 27, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Health Network, Toronto
Responsible Party: Principal Investigator
Investigator: Anuj Bhatia
Official Title: Staff Anesthesiologist
Affiliation: University Health Network, Toronto
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Neuropathic or nerve injury related pain (NP), an extremely unpleasant condition that is difficult to treat, often has a severe, persistent, and unremitting course. Conventional treatments are often ineffective in relieving NP. Recently, the investigators have developed a cost-efficient regimen involving use of low dose infusions of ketamine for treating neuropathic pain in patients in whom oral medications have failed. We have observed excellent benefits in many of these patients. However, this treatment requires titration and monitoring during the infusion and currently it is not possible to predict which patients will benefit from this intervention. The investigators have shown that functional magnetic resonance imaging (fMRI) of the brain can be used as a tool to predict relief of pain and to assess the effect of treatment in some chronic pain conditions. This innovative project involves development of an fMRI-guided treatment with intravenous ketamine in patients with NP. This study aims to analyze patterns of changes in fMRI of the brain, before and after infusion of ketamine and to correlate the changes with pain intensity. The information from this study will help to deliver this therapy earlier to those patients who are most likely to benefit from ketamine.
Detailed Description: This trial is exploratory, prospective, non-randomized, single cohort, single-center, with no blinding of participants, treating physicians, and investigators. Study participants undergo a resting-state fMRI before, after and at '1-month post-ketamine infusion' (standard care). Patients will be recruited over 2 years, from Pain Clinics at Toronto Western Hospital and Mount Sinai Hospital. The primary null hypothesis for this trial is that there are no fMRI brain patterns of patients with neuropathic pain that predict pain relief following ketamine infusion. The secondary null hypothesis for this trial is that there are no correlations between specific fMRI brain patterns of patients with neuropathic pain and change in intensity of pain immediately following ketamine infusion. Further secondary hypothesis include that cortical reorganization in the brain as measured by fMRI at one month after the infusion of ketamine does not correlate with persisting analgesic benefit in patients with neuropathic pain. Finally, we hypothesize that ketamine infusions do not provide significant pain relief, reduction in anxiety and depression, and improvement in quality of life early (at 1 month) and late (at 3 months) after the infusions in patients with neuropathic pain.
Open or close this module Conditions
Conditions: Neuralgia
Keywords: Ketamine
fMRI
refractory neuropathic pain
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: RS-fMRI
All subjects will be instructed to keep their eyes closed but to remain awake during the fMRI measurement. Resting State fMRI (RS-fMRI) will be performed within four weeks of planned infusion of ketamine, immediately after the end of infusion of ketamine on the fifth (last) day of infusion, and on the one month follow-up appointment after the infusion.
RS-fMRI
Resting State-functional Magnetic Resonance Imaging. Protocols involving BOLD (blood oxygen level-dependent) and non-BOLD techniques will be used.
Drug: Ketamine
Part of standard care. To be performed over five consecutive days (Monday to Friday) for six hours per day. A therapeutic range of 0.5 to 2.0 mg/kg/hour is targeted.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Correlation between 'baseline (pre-infusion) fMRI patterns' and 'pain relief (>50% pain reduction, as per NRS or 'Numerical Rating Scale')'
[ Time Frame: 1 month following ketamine infusion ]

Secondary Outcome Measures:
1. Correlation between 'specific fMRI brain patterns at 1-month post-infusion' and 'change in neuropathic pain intensity (as per NRS) at 3-month post-infusion'
[ Time Frame: 3 months following ketamine infusion ]

2. Change in pain intensity at 1 month post-infusion, as measured by Brief Pain Inventory (BPI)
[ Time Frame: 1 month following ketamine infusion ]

3. Change in pain intensity at 3 months post-infusion, as measured by Brief Pain Inventory (BPI)
[ Time Frame: 3 months following ketamine infusion ]

4. Change in anxiety at 1 month post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)
[ Time Frame: 1 month following ketamine infusion ]

5. Change in anxiety at 3 months post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)
[ Time Frame: 3 months following ketamine infusion ]

6. Change in depression at 1 month post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)
[ Time Frame: 1 month following ketamine infusion ]

7. Change in depression at 3 months post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)
[ Time Frame: 3 months following ketamine infusion ]

8. Change in quality of life at 1 month post-infusion, as measured by Short Form-36 (SF-36) v2 Health Survey
[ Time Frame: 1 month following ketamine infusion ]

9. Change in quality of life at 3 months post-infusion, as measured by Short Form-36 (SF-36) v2 Health Survey
[ Time Frame: 3 month following ketamine infusion ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Refractory neuropathic pain diagnosed by a >3 score on DN4 (Douleur Neuropathique 4) questionnaire
  • Average daily pain intensity should be moderate or severe, as indicated by a >3 score on NRS (Numerical Rating Scale)
  • Duration of neuropathic pain should be more than three months
  • Participants should have tried at least three medications for neuropathic pain. Each of these medications should belong to a different pharmacological group: anticonvulsants (gabapentin, pregabalin), tricyclic antidepressants (amitriptyline, nortriptyline, imipramine, desipramine), serotonin noradrenaline reuptake inhibitors (venlafaxine, duloxetine), tramadol, opioids, cannabinoids, methadone, topical lidocaine and capsaicin patches.

Exclusion Criteria:

  • Ketamine or lidocaine intravenous infusion within the 6 months preceding enrollment into this trial
  • Contraindications to ketamine (allergy, pregnancy, uncontrolled arterial hypertension, uncontrolled hyperthyroidism, severe ischemic heart disease or heart failure, severe liver or kidney disease, space occupying lesion in the brain or the spinal cord, uncontrolled epilepsy and glaucoma)
  • Ongoing litigation issues related to the patient's pain that may affect reporting of pain and quality of life
  • An unstable medical or psychiatric condition that makes it unsafe to use study medications
  • Participants unable to comply with the study protocol (e.g. follow-up visits, filling forms for measuring anxiety, depression, and quality of life)
  • Relative (claustrophobia) or absolute contraindications for MRI
Open or close this module Contacts/Locations
Central Contact Person: Daeniell Miller
Telephone: 416-581-7818
Email: dmiller@uhnresearch.ca
Study Officials: Anuj Bhatia
Principal Investigator
UHN
Locations: Canada, Ontario
Toronto Western Hospital
[Recruiting]
Toronto, Ontario, Canada, M5T2S8
Contact:Contact: Anuj Bhatia, MD FRCPC 4166035800 Ext. 2002 anuj.bhatia@uhn.ca
Contact:Contact: Sabeeh Alvi, BSc Honours 4166035800 Ext. 3959 sabeeh.alvi@uhn.ca
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services