Orofacial PainNeuroFaceNCT07352384
Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain
A study testing Active Neuromodulation (tDCS or TMS) in people with Orofacial Pain, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Orofacial Pain
- What is being tested?
- Active Neuromodulation (tDCS or TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Egas Moniz School of Health and Science
Almada, Setúbal District, 2825-148
About this study
Official title: Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain: A Randomized Controlled Trial
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.
Read the detailed description
The study will be conducted at the University Clinic of the Egas Moniz School of Health and Science - Department of Orofacial Pain. The objective is to evaluate the effects of electrical and magnetic neuromodulation on different chronic pain conditions using standardized non-invasive brain stimulation protocols and validated clinical and functional assessment instruments.
Sample
Individuals with chronic low back pain (score between 40 and 80 on the Portuguese version of the Oswestry Disability Index) and chronic orofacial pain (score between 40 and 80 on the Portuguese version of the Manchester Orofacial Pain Disability Scale) will be selected.
For each chronic pain condition, 50 individuals will be enrolled and allocated into two groups: a control group and an intervention group.
Inclusion Criteria
Age between 18 and 75 years.
Diagnosis of chronic orofacial pain lasting longer than 3 months, confirmed by validated diagnostic criteria such as DC/TMD.
Initial Visual Analogue Scale (VAS) score ≥ 4.
Previous attempt of at least one conventional treatment with limited effectiveness.
Cognitive capacity sufficient to understand study procedures and provide informed consent.
Stable chronic pain medication regimen for at least four weeks prior to the intervention.
Exclusion Criteria
History of epilepsy, seizures, or other neurological conditions that contraindicate tDCS or TMS.
Presence of implanted medical devices, including pacemakers, cochlear implants, or other electronic/metallic devices in the head or neck region.
Pregnancy or breastfeeding.
Severe psychiatric disorders that may compromise adherence to study procedures.
Current or recent history (within the last six months) of alcohol or substance abuse.
Active infections or untreated systemic diseases that may interfere with the intervention or outcomes.
History of temporomandibular joint surgery or recent invasive dental procedures (within the last three months).
Known contraindications to TMS or tDCS, including intolerance to neuromodulation.
Participation in another clinical trial within the last three months.
Randomization
Participants will be randomly allocated to the control or intervention group by an independent investigator using an electronic randomization tool (Research Randomizer). Allocation will remain concealed until completion of assessments.
Sample Size Calculation
Sample size estimation indicates the need for 15 participants per group to ensure a statistical power of 85% (β = 0.20) and a significance level of p < 0.05. The final sample size was expanded to enhance the robustness of statistical analyses and to compensate for potential dropouts.
Assessment Instruments Visual Analogue Scale (VAS)
A 0-10 numerical scale used to quantify pain intensity, where 0 indicates no pain and 10 represents the worst imaginable pain.
Brief Pain Inventory (BPI)
A multidimensional tool that assesses pain intensity and pain interference with daily activities over the past 24 hours.
Graded Chronic Pain Scale (GCPS)
A scale that classifies chronic pain into severity grades based on pain intensity and functional disability.
SF-36 Health Survey
A generic quality-of-life questionnaire comprising 36 items distributed across eight domains, with scores ranging from 0 (worst health status) to 100 (best health status).
Manchester Orofacial Pain Disability Scale
An instrument that measures functional disability associated with orofacial pain, focusing on daily activities such as chewing and speaking.
Pressure Pain Threshold (PPT)
Assessed using a portable algometer. The minimum pressure that elicits a painful sensation will be recorded. Each site will be measured twice, and the mean value will be used for analysis.
Intervention Transcranial Direct Current Stimulation (tDCS)
tDCS will be administered using 35 cm² electrodes for 20 minutes across five consecutive days. The anode will be positioned at C3 or C4, contralateral to the primary site of pain, according to the international 10-20 EEG system. The control group will receive sham stimulation with identical electrode placement and procedures.
Transcranial Magnetic Stimulation (TMS)
TMS will be delivered in 10 sessions over two weeks. The intervention group will receive active stimulation, while the control group will receive sham stimulation. Stimulation parameters (frequency, intensity, and coil placement) will follow standardized clinical research guidelines for chronic pain.
- Conditions
- Orofacial Pain
- Being tested
- Active Neuromodulation (tDCS or TMS), Sham Neuromodulation (tDCS or TMS)
- Keywords
- Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Neuromodulation, Orofacial Pain, Chronic Pain
- Medical subject headings
- Facial Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Neuromodulation (tDCS or TMS)Device
Also called Active tDCS, Active TMS, Active neuromodulation therapy
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.
Sham Neuromodulation (tDCS or TMS)Device
Also called Sham tDCS, Sham TMS, Placebo neuromodulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Neuromodulation (tDCS or TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pain-related interference will be evaluated using the interference subscale of the Brief Pain Inventory (BPI). The BPI assesses the extent to which pain interferes with daily activities, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. Each item is rated on a 0-10 numeric scale, with higher scores indicating greater interference.
Measured: 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)
Chronic pain severity will be assessed using the Graded Chronic Pain Scale (GCPS), which classifies pain according to pain intensity and pain-related disability. The GCPS generates grades ranging from Grade 0 (no pain) to Grade IV (high disability-severely limiting), with higher grades indicating greater pain-related impairment.
Measured: 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
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better perceived health status.
Measured: 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)
Pressure pain threshold will be measured using a pressure algometer applied to predefined orofacial and/or cervical muscle sites. PPT is defined as the minimum pressure (expressed in kPa or kg/cm²) at which pressure sensation becomes painful. Higher PPT values indicate lower pain sensitivity.
Measured: 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)
Orofacial functional disability will be evaluated using the Manchester Orofacial Pain Disability Scale (MOPDS), a self-reported questionnaire that assesses the impact of orofacial pain on daily functional activities. Higher scores reflect greater levels of functional disability related to orofacial pain.
Measured: Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, University of Aarhus, Universidade Federal de Alfenas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352384
- Sponsor's protocol ID
- CEEM1660
- Acronym
- NeuroFace
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) from this study will not be shared with other researchers. Rationale for Non-Sharing: Informed Consent Limitations: The current informed consent forms signed by participants do not explicitly authorize the future public sharing or distribution of individual raw data, which limits our ability to comply with broad data sharing requests while maintaining ethical compliance. Data Sensitivity and Privacy: The collected data involves sensitive clinical information regarding chronic pain and psychiatric history. Although data is anonymized, the potential for re-identification, especially within small subgroups defined by specific conditions (e.g., both chronic orofacial pain and specific comorbidities), necessitates a conservative approach to protect participant privacy. Study Specificity: The complex, multi-modal intervention (TMS/tDCS) and assessment protocols used are highly specific to the research team's infrastructure and methodology, making the data
Publications
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.
PubMed 28231681Fricova 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.
PubMed 33045706Mayor 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.
PubMed 38956966Ferreira 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.
PubMed 31415654Herrero 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.
PubMed 30122975Knotkova 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.
PubMed 34062145
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07352384
- Acronym / sponsor ID
- NeuroFace / CEEM1660
- Conditions
- Orofacial Pain
- Keywords
- Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Neuromodulation, Orofacial Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- University of Sao Paulo, University of Aarhus, Universidade Federal de Alfenas
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted at the University Clinic of the Egas Moniz School of Health and Science - Department of Orofacial Pain. The objective is to evaluate the effects of electrical and magnetic neuromodulation on different chronic pain conditions using standardized non-invasive brain stimulation protocols and validated clinical and functional assessment instruments.
Sample
Individuals with chronic low back pain (score between 40 and 80 on the Portuguese version of the Oswestry Disability Index) and chronic orofacial pain (score between 40 and 80 on the Portuguese version of the Manchester Orofacial Pain Disability Scale) will be selected.
For each chronic pain condition, 50 individuals will be enrolled and allocated into two groups: a control group and an intervention group.
Inclusion Criteria
Age between 18 and 75 years.
Diagnosis of chronic orofacial pain lasting longer than 3 months, confirmed by validated diagnostic criteria such as DC/TMD.
Initial Visual Analogue Scale (VAS) score ≥ 4.
Previous attempt of at least one conventional treatment with limited effectiveness.
Cognitive capacity sufficient to understand study procedures and provide informed consent.
Stable chronic pain medication regimen for at least four weeks prior to the intervention.
Exclusion Criteria
History of epilepsy, seizures, or other neurological conditions that contraindicate tDCS or TMS.
Presence of implanted medical devices, including pacemakers, cochlear implants, or other electronic/metallic devices in the head or neck region.
Pregnancy or breastfeeding.
Severe psychiatric disorders that may compromise adherence to study procedures.
Current or recent history (within the last six months) of alcohol or substance abuse.
Active infections or untreated systemic diseases that may interfere with the intervention or outcomes.
History of temporomandibular joint surgery or recent invasive dental procedures (within the last three months).
Known contraindications to TMS or tDCS, including intolerance to neuromodulation.
Participation in another clinical trial within the last three months.
Randomization
Participants will be randomly allocated to the control or intervention group by an independent investigator using an electronic randomization tool (Research Randomizer). Allocation will remain concealed until completion of assessments.
Sample Size Calculation
Sample size estimation indicates the need for 15 participants per group to ensure a statistical power of 85% (β = 0.20) and a significance level of p < 0.05. The final sample size was expanded to enhance the robustness of statistical analyses and to compensate for potential dropouts.
Assessment Instruments Visual Analogue Scale (VAS)
A 0-10 numerical scale used to quantify pain intensity, where 0 indicates no pain and 10 represents the worst imaginable pain.
Brief Pain Inventory (BPI)
A multidimensional tool that assesses pain intensity and pain interference with daily activities over the past 24 hours.
Graded Chronic Pain Scale (GCPS)
A scale that classifies chronic pain into severity grades based on pain intensity and functional disability.
SF-36 Health Survey
A generic quality-of-life questionnaire comprising 36 items distributed across eight domains, with scores ranging from 0 (worst health status) to 100 (best health status).
Manchester Orofacial Pain Disability Scale
An instrument that measures functional disability associated with orofacial pain, focusing on daily activities such as chewing and speaking.
Pressure Pain Threshold (PPT)
Assessed using a portable algometer. The minimum pressure that elicits a painful sensation will be recorded. Each site will be measured twice, and the mean value will be used for analysis.
Intervention Transcranial Direct Current Stimulation (tDCS)
tDCS will be administered using 35 cm² electrodes for 20 minutes across five consecutive days. The anode will be positioned at C3 or C4, contralateral to the primary site of pain, according to the international 10-20 EEG system. The control group will receive sham stimulation with identical electrode placement and procedures.
Transcranial Magnetic Stimulation (TMS)
TMS will be delivered in 10 sessions over two weeks. The intervention group will receive active stimulation, while the control group will receive sham stimulation. Stimulation parameters (frequency, intensity, and coil placement) will follow standardized clinical research guidelines for chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Neuromodulation | Active comparator | Device: Active Neuromodulation (tDCS or TMS)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. |
| Sham/Placebo Neuromodulation | Placebo comparator | Device: Sham Neuromodulation (tDCS or TMS)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Neuromodulation (tDCS or TMS)Also: Active tDCS, Active TMS, Active neuromodulation therapyParticipants 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 | Active Neuromodulation |
| Sham Neuromodulation (tDCS or TMS)Also: Sham tDCS, Sham TMS, Placebo neuromodulationParticipants 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. | Device | Sham/Placebo Neuromodulation |
Primary outcome
Pain Intensity Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention
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.
5 secondary outcomes
Pain Interference Measured by the Brief Pain Inventory (BPI)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 28231681Fricova 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.
- Results publication: PubMed 33045706Fricova 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.
- Results publication: PubMed 38956966Mayor 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.
- Results publication: PubMed 31415654Ferreira 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.
- Results publication: PubMed 30122975Herrero 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.
- Results publication: PubMed 34062145Knotkova 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.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) from this study will not be shared with other researchers. Rationale for Non-Sharing: Informed Consent Limitations: The current informed consent forms signed by participants do not explicitly authorize the future public sharing or distribution of individual raw data, which limits our ability to comply with broad data sharing requests while maintaining ethical compliance. Data Sensitivity and Privacy: The collected data involves sensitive clinical information regarding chronic pain and psychiatric history. Although data is anonymized, the potential for re-identification, especially within small subgroups defined by specific conditions (e.g., both chronic orofacial pain and specific comorbidities), necessitates a conservative approach to protect participant privacy. Study Specificity: The complex, multi-modal intervention (TMS/tDCS) and assessment protocols used are highly specific to the research team's infrastructure and methodology, making the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Neuromodulation (tDCS or TMS) in people with Orofacial Pain, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analogue Scale (VAS) (time frame: Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07352384, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.