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Neuropathic Dental Pain & DBS

22. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

5

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z1M9
        • Rekrutierung
        • Vancouver General Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
Gerät: 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.
Experimental: Ventral Posteromedial Nucleus (VPM) Stimulation
Participants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus.
Gerät: 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.
Experimental: Anterior Pulvinar (aPu) Stimulation
Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus.
Gerät: 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.
Experimental: Centromedian Nucleus (CM) Stimulation
Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus.
Gerät: 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.
Kein Eingriff: Stimulation Off
Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Severity Measured by Visual Analogue Scale (VAS)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of British Columbia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • H24-01903

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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