Neuropathic Dental Pain & DBS

NCT07671950 | Recruiting DMC

• 1 other identifier: H24-01903
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Neuralgia; Neuropathic Dental Pain

Keywords

Neuropathic Dental Pain; Dental Neuralgia; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Pain Severity Measured by Visual Analogue Scale (VAS)

  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 Outcomes (5)

• Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

  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)

  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)

  Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.

• Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)

  Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.

• Change in Pain Severity Assessed by the Visual Analogue Scale (VAS)

  Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.

Study Arms (5)

Ring-Mode Stimulation

EXPERIMENTAL

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

Ventral Posteromedial Nucleus (VPM) Stimulation

EXPERIMENTAL

Participants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus.

Device: Directional Deep Brain Stimulation

Anterior Pulvinar (aPu) Stimulation

EXPERIMENTAL

Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus.

Device: Directional Deep Brain Stimulation

Centromedian Nucleus (CM) Stimulation

EXPERIMENTAL

Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus.

Device: Directional Deep Brain Stimulation

Stimulation Off

NO INTERVENTION

Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings.

Interventions

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.

Anterior Pulvinar (aPu) Stimulation; Centromedian Nucleus (CM) Stimulation; Ring-Mode Stimulation; Ventral Posteromedial Nucleus (VPM) Stimulation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Central Study Contacts

Danielle Pietramala

CONTACT

604-875-4111; danielle.pietram@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: N

Model Details: Participants will undergo directional deep brain stimulation (DBS) for neuropathic dental pain. Following postoperative activation, each participant will receive five stimulation conditions in a randomized sequence: (1) ring-mode stimulation, (2) directional stimulation toward the ventral posteromedial nucleus (VPM), (3) directional stimulation toward the anterior pulvinar (aPu), (4) directional stimulation toward the centromedian nucleus (CM), and (5) stimulation off. Participants will remain on each condition for two weeks and will be blinded to the stimulation setting. Pain assessments will be completed following each condition, allowing each participant to serve as their own control for comparison of pain outcomes across stimulation targets.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

CA (1)