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ENROLLING BY INVITATION
NCT07352384
NA

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

Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-01

Completion Date

2026-08-01

Last Updated

2026-02-20

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Active Neuromodulation (tDCS or TMS)

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.

DEVICE

Sham Neuromodulation (tDCS or TMS)

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.

Locations (1)

Egas Moniz School of Health and Science

Almada, Setúbal District, Portugal