Neuropathic Dental Pain & DBS

June 22, 2026 updated by: Christopher Honey, University of British Columbia

Pain Alleviation for Patients Receiving Directional Deep Brain Stimulation to Treat Neuropathic Dental Pain

This prospective observational study will evaluate pain outcomes in patients with neuropathic dental pain (Atypical Odontalgia/Phantom Tooth Pain) who undergo directional deep brain stimulation (DBS). Participants will complete validated pain, disability, quality-of-life, and mood assessments before surgery and following DBS programming. Directional stimulation will be applied to different thalamic targets to determine whether specific stimulation settings are associated with greater pain relief. The study aims to characterize changes in pain and quality of life following DBS and to identify the stimulation target associated with the greatest reduction in neuropathic dental pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neuropathic dental pain, also known as Atypical Odontalgia (AO) or Phantom Tooth Pain (PTP), is a chronic pain condition characterized by persistent tooth or facial pain in the absence of identifiable dental pathology. The condition is thought to result from injury to peripheral nerve structures that leads to alterations in central pain processing. Standard treatments, including antidepressants, neuroleptic medications, local anesthetic injections, corticosteroids, and nerve blocks, may provide relief for some patients; however, a subset of patients continue to experience debilitating pain despite these interventions.

Deep brain stimulation (DBS) is an established neurosurgical therapy for several neurological disorders and has been used off-label for the treatment of chronic neuropathic pain. Previous studies suggest that stimulation of thalamic structures involved in pain processing, including the ventral posteromedial nucleus (VPM), centromedian nucleus (CM), and anterior pulvinar (aPu), may provide pain relief for neuropathic facial pain. However, no established DBS target currently exists for neuropathic dental pain.

This prospective observational study will evaluate pain outcomes in patients with neuropathic dental pain who undergo directional DBS. Directional DBS leads will be implanted in a location that permits stimulation of the VPM, CM, and aPu regions of the thalamus. Following surgery, participants will undergo routine clinical programming during which stimulation settings will be systematically adjusted to direct stimulation toward each target region, as well as ring-mode stimulation and an off-stimulation condition. Participants will remain blinded to the stimulation settings.

Participants will complete validated measures of pain, pain-related disability, quality of life, and depressive symptoms before surgery and after completion of the programming period. Visual Analog Scale (VAS) pain ratings will also be collected following each stimulation condition to evaluate differences in pain relief between targets. The primary objective is to assess changes in pain levels associated with different stimulation settings and identify the stimulation target associated with the greatest reduction in neuropathic dental pain. Secondary objectives include evaluating changes in pain-related disability, quality of life, and mood following DBS treatment.

The findings from this study will provide preliminary evidence regarding optimal thalamic stimulation targets for neuropathic dental pain and may inform future research and treatment approaches for patients with this challenging and currently underserved condition.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 19 to 80 years.
  • Diagnosis of Atypical Odontalgia (AO) (also known as neuropathic dental pain).
  • Receiving deep brain stimulation (DBS) treatment for AO due to inadequate response to conventional therapies, including: Pharmacological therapies, and/or Local anesthetics, corticosteroid injections, or nerve blocks.
  • Able and willing to provide informed consent.

Exclusion Criteria:

  • Refusal or inability to provide informed consent.
  • Known major depression.
  • Acute psychosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ring-Mode Stimulation
Participants receive DBS ring-mode stimulation, allowing current to spread across the target region encompassing the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), and centromedian nucleus (CM).
Device: Directional Deep Brain Stimulation
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system. Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off. Participants will undergo each stimulation condition in a randomized sequence.
Experimental: Ventral Posteromedial Nucleus (VPM) Stimulation
Participants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus.
Device: Directional Deep Brain Stimulation
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system. Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off. Participants will undergo each stimulation condition in a randomized sequence.
Experimental: Anterior Pulvinar (aPu) Stimulation
Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus.
Device: Directional Deep Brain Stimulation
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system. Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off. Participants will undergo each stimulation condition in a randomized sequence.
Experimental: Centromedian Nucleus (CM) Stimulation
Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus.
Device: Directional Deep Brain Stimulation
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system. Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off. Participants will undergo each stimulation condition in a randomized sequence.
No Intervention: Stimulation Off
Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity Measured by Visual Analogue Scale (VAS)
Time Frame: Baseline (pre-operative); after each 2-week stimulation period during the 10-week post-activation programming phase; and 3 months after completion of the randomized stimulation period.
Pain severity will be assessed using the Visual Analogue Scale (VAS). Participants will complete the VAS following two weeks on each of five stimulation settings (ring mode, VPM, aPu, CM, and off stimulation). The primary outcome is the comparison of VAS scores across stimulation settings to identify the setting associated with the greatest pain reduction.
Baseline (pre-operative); after each 2-week stimulation period during the 10-week post-activation programming phase; and 3 months after completion of the randomized stimulation period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time Frame: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Pain characteristics and severity will be assessed using the SF-MPQ-2. Changes from baseline to follow-up will be evaluated.
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Pain-Related Disability Assessed by the Pain Disability Index (PDI)
Time Frame: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
The impact of pain on daily functioning will be measured using the Pain Disability Index. Changes from baseline to follow-up will be evaluated.
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Survey (SF-36)
Time Frame: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Health-related quality of life will be measured using the SF-36 questionnaire. Changes from baseline to follow-up will be evaluated.
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Time Frame: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Depressive symptoms will be measured using the Beck Depression Inventory. Changes from baseline to follow-up will be evaluated.
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Pain Severity Assessed by the Visual Analogue Scale (VAS)
Time Frame: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Overall pain intensity will be compared between baseline and follow-up while participants are maintained on their optimal stimulation setting.
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H24-01903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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