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Neuropathic Dental Pain & DBS

22 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

5

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Reclutamento
        • Vancouver General Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Dispositivo: 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.
Sperimentale: Ventral Posteromedial Nucleus (VPM) Stimulation
Participants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus.
Dispositivo: 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.
Sperimentale: Anterior Pulvinar (aPu) Stimulation
Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus.
Dispositivo: 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.
Sperimentale: Centromedian Nucleus (CM) Stimulation
Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus.
Dispositivo: 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.
Nessun intervento: Stimulation Off
Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Severity Measured by Visual Analogue Scale (VAS)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of British Columbia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • H24-01903

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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