Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain

NCT07352384 | Enrolling By Invitation

• 1 other identifier: CEEM1660
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic orofacial pain significantly affects patients' quality of life, compromising essential functions such as chewing and speech. Although conventional treatments are available, many patients do not achieve adequate and lasting relief. This project investigates the effectiveness of neuromodulation techniques, namely transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS), as innovative therapeutic alternatives for the control of chronic orofacial pain. The study will be conducted in adult patients diagnosed with orofacial pain. Participants will be divided into two groups: one group will receive active neuromodulation (tDCS or TMS) and the other a sham treatment (placebo). Sessions will take place daily over two weeks. Assessments will include pain intensity, pain pressure threshold, masticatory function, and bite strength, in order to observe any functional changes. The group undergoing neuromodulation is expected to show a significant reduction in pain levels and improvements in quality of life compared to the placebo group. This study could support the adoption of neuromodulation as a complementary approach in the treatment of chronic orofacial pain, offering an effective and non-invasive alternative for patients who do not respond to conventional treatments.

Conditions

Orofacial Pain

Keywords

Transcranial Magnetic Stimulation (TMS); Transcranial Direct Current Stimulation (tDCS); Neuromodulation; Orofacial Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Assessed by Visual Analogue Scale (VAS)

  Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), in which participants rate their average pain intensity by marking a point on a horizontal line anchored by "no pain" (0) and "worst pain imaginable" (10). Higher scores indicate greater pain intensity.

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

Secondary Outcomes (5)

• Pain Interference Measured by the Brief Pain Inventory (BPI)

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

• Chronic Pain Severity Assessed by the Graded Chronic Pain Scale (GCPS)

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

• Health-Related Quality of Life Measured by SF-36

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

• Pressure Pain Threshold (PPT)

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

• Orofacial Functional Disability Assessed by the Manchester Orofacial Pain Disability Scale (MOPDS)

  Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention

Study Arms (2)

Active Neuromodulation

ACTIVE COMPARATOR

Participants assigned to this arm receive active neuromodulation using either transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS), according to the study protocol. Stimulation parameters follow standardized therapeutic settings, including electrode/coil placement, intensity, and session duration. The intervention is delivered over a 2-week schedule. Active stimulation is designed to modulate cortical excitability and pain-related neural circuits.

Device: Active Neuromodulation (tDCS or TMS)

Sham/Placebo Neuromodulation

PLACEBO COMPARATOR

Participants in this arm receive sham (placebo) neuromodulation designed to mimic the sensory experience of tDCS or TMS without delivering effective stimulation. For tDCS, the device provides brief ramp-up/ramp-down current; for TMS, a sham coil or tilted coil reproduces sound and scalp sensation without inducing cortical effects. Procedures, duration, and interactions are identical to the active arm to maintain blinding.

Device: Sham Neuromodulation (tDCS or TMS)

Interventions

Active Neuromodulation (tDCS or TMS) DEVICE

Participants receive active non-invasive neuromodulation using either transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS). For tDCS, stimulation is delivered with 35 cm² electrodes, 1-2 mA, for 20 minutes, with the anode placed over C3 or C4 contralateral to the pain side, for five consecutive sessions. For TMS, stimulation is delivered with a figure-of-eight coil targeting the motor cortex corresponding to the orofacial region, following established safety protocols (e.g., 10 sessions across two weeks). All procedures follow standardized therapeutic parameters aiming to modulate cortical excitability and reduce pain.

Also known as: Active tDCS, Active TMS, Active neuromodulation therapy

Active Neuromodulation

Sham Neuromodulation (tDCS or TMS) DEVICE

Participants receive sham stimulation designed to mimic the sensory experience of tDCS or TMS without producing physiological neuromodulatory effects. For tDCS, the device uses brief ramp-up/ramp-down currents to simulate tingling without active stimulation. For TMS, a sham coil or angled coil is used to reproduce acoustic and scalp sensations while preventing magnetic induction. Session duration, procedures, and interaction with the operator are identical to the active arm to maintain blinding integrity.

Also known as: Sham tDCS, Sham TMS, Placebo neuromodulation

Sham/Placebo Neuromodulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Participants between 18 and 75 years old.
• Diagnosis of Chronic Orofacial Pain: Patients with persistent orofacial pain for more than 3 months, confirmed using DC/TMD or other validated diagnostic criteria.
• Pain Intensity: Baseline score on the Visual Analogue Scale (VAS) ≥ 4 (moderate to severe pain).
• Treatment History: Patients who have previously tried at least one conventional treatment (e.g., medication or physiotherapy) with limited or no success.
• Cognitive Ability: Participants cognitively able to understand the study procedures and provide informed consent.
• Stable Medication Regimen: Stable chronic pain medication for at least four weeks prior to the intervention.

You may not qualify if:

• Neurological Disorders: History of epilepsy, seizures, or other neurological disorders that contraindicate TMS or tDCS.
• Implanted Medical Devices: Presence of pacemakers, cochlear implants, or other electronic/metallic devices in the head or neck region.
• Pregnancy: Pregnant or breastfeeding individuals, due to potential risks.
• Psychiatric Disorders: Severe psychiatric disorders (e.g., schizophrenia, unstable major depression) that may interfere with study adherence.
• Substance Abuse: Current or recent history (within the last 6 months) of alcohol or substance abuse.
• Active Medical Conditions: Active infections or untreated systemic diseases that may interfere with results.
• TMJ Surgery: History of recent temporomandibular joint surgery or invasive dental procedures (within the last 3 months).
• Contraindications for TMS/tDCS: Sensitivity, intolerance, or inability to tolerate the neuromodulation device.
• Participation in Another Study: Simultaneous or recent (within the last 3 months) participation in another clinical trial.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• University of Sao Paulo: collaborator
• University of Aarhus: collaborator
• Universidade Federal de Alfenas: collaborator

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Setúbal District, 2825-148, Portugal

Location

Related Publications (6)

• Fricova J, Englerova K, Rokyta R. Noninvasive transcranial direct current stimulation (tDCS) for the treatment of orofacial pain. Neuro Endocrinol Lett. 2016 Oct;37(5):368-372.

  PMID: 28231681 BACKGROUND

• Fricova J, Rokyta R. Transcranial Neurostimulation (rTMS, tDCS) in the Treatment of Chronic Orofacial Pain. Prog Neurol Surg. 2020;35:125-132. doi: 10.1159/000511134. Epub 2020 Oct 12.

  PMID: 33045706 RESULT

• Mayor RS, Ferreira NR, Lanzaro C, Castelo-Branco M, Valentim A, Donato H, Lapa T. Noninvasive transcranial brain stimulation in central post-stroke pain: A systematic review. Scand J Pain. 2024 Jul 3;24(1). doi: 10.1515/sjpain-2023-0130. eCollection 2024 Jan 1.

  PMID: 38956966 RESULT

• Ferreira NR, Junqueira YN, Correa NB, Fonseca EO, Brito NBM, Menezes TA, Magini M, Fidalgo TKS, Ferreira DMTP, de Lima RL, Carvalho AC, DosSantos MF. The efficacy of transcranial direct current stimulation and transcranial magnetic stimulation for chronic orofacial pain: A systematic review. PLoS One. 2019 Aug 15;14(8):e0221110. doi: 10.1371/journal.pone.0221110. eCollection 2019.

  PMID: 31415654 RESULT

• Herrero Babiloni A, Guay S, Nixdorf DR, de Beaumont L, Lavigne G. Non-invasive brain stimulation in chronic orofacial pain: a systematic review. J Pain Res. 2018 Aug 1;11:1445-1457. doi: 10.2147/JPR.S168705. eCollection 2018.

  PMID: 30122975 RESULT

• Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.

  PMID: 34062145 RESULT

MeSH Terms

Conditions

Facial Pain; Chronic Pain

Interventions

Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Magnetic Field Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcome assessors are blinded to group assignment. Active and sham neuromodulation follow identical procedures, session durations, and device setups to maintain blinding. Stimulation operators administer the assigned condition but do not participate in assessments or data analysis to prevent disclosure of allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized, parallel-group, double-blind, sham-controlled interventional trial evaluates the efficacy of non-invasive neuromodulation (tDCS or TMS) in adults with chronic orofacial pain. Participants are allocated 1:1 to active or sham stimulation through a computer-generated randomization sequence. The study includes baseline assessments, a 2-week intervention period, and post-treatment evaluations using validated clinical and functional measures. Blinding is maintained for participants and outcome assessors, with stimulation operators following standardized procedures to prevent unblinding. This design allows a controlled comparison of pain reduction, functional improvement, and safety between groups.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 20, 2026
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)