Health TrialsbyHealthPanel

Neuropathic Dental Pain & DBS

ConditionsDental NeuralgiaNeuropathic Dental Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Refusal or inability to provide informed consent.

Known major depression.

Acute psychosis.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 5 treatment groups
Group A: Ring-Mode StimulationExperimental treatment 1 intervention
Group B: Ventral Posteromedial Nucleus (VPM) StimulationExperimental treatment 1 intervention
Group C: Anterior Pulvinar (aPu) StimulationExperimental treatment 1 intervention
Group D: Centromedian Nucleus (CM) StimulationExperimental treatment 1 intervention
Group E: Stimulation OffNo intervention 0 interventions

Trial outcomes

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.

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.

Secondary outcomes

1

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.

Time frame
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
2

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.

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

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.

Time frame
Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Source ClinicalTrials.gov
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