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NCT Number: NCT07671950

Neuropathic Dental Pain & DBS

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location status: Recruiting

Location contact

Danielle Pietramala

CONTACT

[email protected]

6043495059

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Directional Deep Brain Stimulation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Pietramala

CONTACT

[email protected]

604-875-4111 ext. 68396

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.