Recruiting

DBS

Sponsor:

University of British Columbia

Code:

NCT07671950

Conditions

Dental Neuralgia

Neuropathic Dental Pain

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Directional Deep Brain Stimulation

Study Details

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

Study ID

NCT07671950

Start date

Jan 1, 2026

Status verified date

Jun, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

experimental: Ventral Posteromedial Nucleus (VPM) Stimulation

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

experimental: Anterior Pulvinar (aPu) Stimulation

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

experimental: Centromedian Nucleus (CM) Stimulation

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

no intervention: Stimulation Off

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

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Danielle Pietramala

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

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Danielle Pietramala

6043495059d.pietramala@hotmail.com

More Information

Sponsor

University of British Columbia

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Neuropathic Dental Pain
  • Dental Neuralgia
  • Deep Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-06-26.