Dental NeuralgiaNCT07671950
Neuropathic Dental Pain & DBS
A study testing Directional Deep Brain Stimulation in people with Dental Neuralgia and Neuropathic Dental Pain, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Dental Neuralgia, Neuropathic Dental Pain
- What is being tested?
- Directional Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refusal or inability to provide informed consent.
- Known major depression.
- Acute psychosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Danielle Pietramala, 6043495059, d.pietramala@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Neuralgia, Neuropathic Dental Pain
- Being tested
- Directional Deep Brain Stimulation
- Keywords
- Neuropathic Dental Pain, Dental Neuralgia, Deep Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directional Deep Brain StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Directional Deep Brain Stimulation |
| Anterior Pulvinar (aPu) Stimulation | Experimental | Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus. Receives: Device: Directional Deep Brain Stimulation |
| Centromedian Nucleus (CM) Stimulation | Experimental | Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pain characteristics and severity will be assessed using the SF-MPQ-2. Changes from baseline to follow-up will be evaluated.
Measured: 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)
The impact of pain on daily functioning will be measured using the Pain Disability Index. Changes from baseline to follow-up will be evaluated.
Measured: 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)
Health-related quality of life will be measured using the SF-36 questionnaire. Changes from baseline to follow-up will be evaluated.
Measured: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Depressive symptoms will be measured using the Beck Depression Inventory. Changes from baseline to follow-up will be evaluated.
Measured: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Change in Pain Severity Assessed by the Visual Analogue Scale (VAS)
Overall pain intensity will be compared between baseline and follow-up while participants are maintained on their optimal stimulation setting.
Measured: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671950
- Sponsor's protocol ID
- H24-01903
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Alleviation for Patients Receiving Directional Deep Brain Stimulation to Treat Neuropathic Dental Pain
- ClinicalTrials.gov ID
- NCT07671950
- Acronym / sponsor ID
- H24-01903
- Conditions
- Dental Neuralgia, Neuropathic Dental Pain
- Keywords
- Neuropathic Dental Pain, Dental Neuralgia, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ring-Mode Stimulation | Experimental | Device: Directional Deep Brain StimulationParticipants 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). |
| Ventral Posteromedial Nucleus (VPM) Stimulation | Experimental | Device: Directional Deep Brain StimulationParticipants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus. |
| Anterior Pulvinar (aPu) Stimulation | Experimental | Device: Directional Deep Brain StimulationParticipants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus. |
| Centromedian Nucleus (CM) Stimulation | Experimental | Device: Directional Deep Brain StimulationParticipants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus. |
| Stimulation Off | No intervention | –Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal or inability to provide informed consent.
- Known major depression.
- Acute psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directional Deep Brain StimulationParticipants 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. | Device | Anterior Pulvinar (aPu) Stimulation, Centromedian Nucleus (CM) Stimulation, Ring-Mode Stimulation, Ventral Posteromedial Nucleus (VPM) Stimulation |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directional Deep Brain Stimulation in people with Dental Neuralgia and Neuropathic Dental Pain, run by University of British Columbia 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 3 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Pietramala (604-875-4111 ext. 68396, danielle.pietram@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.