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NeuralgiaNCT02373449

Ketamine and fMRI for Neuropathic Pain

A study testing RS-fMRI and Ketamine in people with Neuralgia, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Neuralgia
What is being tested?
RS-fMRI and Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteCanada
Study dates
Feb 2015to Dec 2020
Phase
Interventional
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Western Hospital

    Toronto, Ontario, M5T2S8

Other trials in Canada

About this study

Official title: Functional Magnetic Resonance Imaging to Predict and Correlate Clinical Outcomes of Ketamine Infusions for Refractory Neuropathic Pain

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.

Read the 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.

Conditions
Neuralgia
Being tested
RS-fMRI, Ketamine
Keywords
Ketamine, fMRI, refractory neuropathic pain
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RS-fMRIOther

    Resting State-functional Magnetic Resonance Imaging. Protocols involving BOLD (blood oxygen level-dependent) and non-BOLD techniques will be used.

  • KetamineDrug

    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.

Study groups in NCT02373449
Study groupRoleWhat they receive
RS-fMRIExperimentalAll 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.
Receives: Other: RS-fMRI; Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between 'baseline (pre-infusion) fMRI patterns' and 'pain relief (>50% pain reduction, as per NRS or 'Numerical Rating Scale')'

    Measured: 1 month following ketamine infusion

Secondary outcomes (9)

  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'

    Measured: 3 months following ketamine infusion

  2. Change in pain intensity at 1 month post-infusion, as measured by Brief Pain Inventory (BPI)

    Measured: 1 month following ketamine infusion

  3. Change in pain intensity at 3 months post-infusion, as measured by Brief Pain Inventory (BPI)

    Measured: 3 months following ketamine infusion

  4. Change in anxiety at 1 month post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)

    Measured: 1 month following ketamine infusion

  5. Change in anxiety at 3 months post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)

    Measured: 3 months following ketamine infusion

  6. Change in depression at 1 month post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)

    Measured: 1 month following ketamine infusion

  7. Change in depression at 3 months post-infusion, as measured by Hospital Anxiety and Depression Scale (HADS)

    Measured: 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

    Measured: 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

    Measured: 3 month following ketamine infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2019
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02373449
Sponsor's protocol ID
14-8706-AE
Status last verified
Apr 2021
First submitted
9 Feb 2015
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mills EP, Bosma RL, Rogachov A, Cheng JC, Osborne NR, Kim JA, Besik A, Bhatia A, Davis KD. Pretreatment Brain White Matter Integrity Associated With Neuropathic Pain Relief and Changes in Temporal Summation of Pain Following Ketamine. J Pain. 2024 Sep;25(9):104536. doi: 10.1016/j.jpain.2024.104536. Epub 2024 Apr 12.

    PubMed 38615801

Questions about this trial

What is this clinical trial studying?

A study testing RS-fMRI and Ketamine in people with Neuralgia, run by University Health Network, Toronto at 1 site in Canada.

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 6 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: finished, as of the sponsor's last update on 28 Apr 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT02373449, which also lists 1 linked publication.

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 28 Apr 2021.

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