Orofacial PainNCT05584384
The Use of tDCS in the Orofacial Pain
A study testing Transcranial Direct Current Stimulation in people with Orofacial Pain, run by Charles University, Czech Republic.
Trial summary
The trial´s main goal is to explore the use of transcranial direct current stimulation (tDCS) as a treatment option for persons suffering from orofacial pain. The aim of the trial is to further investigate the efficacy and longevity of tDCS in treating chronic pharmacoresistant orofacial pain. 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?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of Orofacial Pain by a pain medicine specialist according to ICOP (International classification of orofacial pain) and ICHD3 (International classification of headache disorder)
- Stable analgesic therapy one month before the stimulation series
Who cannot join
- Changes to the analgesic therapy in 6 months following the stimulation series
- Non-compliance with the follow-ups
- General contraindications to tDCS - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses
About this study
Official title: The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain
The trial´s main goal is to explore the use of transcranial direct current stimulation (tDCS) as a treatment option for persons suffering from orofacial pain. The aim of the trial is to further investigate the efficacy and longevity of tDCS in treating chronic pharmacoresistant orofacial pain.
A prospective, randomized, double-blinded, two-arm, sham-controlled design will be utilized. Primarily, the analgesic effect's intensity and duration will be assessed. Secondarily, the associated reduction of symptoms of anxiety and depression will be investigated, as well as the impact on the general quality of life. Anodal stimulation (6 sessions in 2 weeks, 2mA, 20 min, cathode over the opposite Fp area) of M1 contralateral to the pain location will be employed. Washout periods of 48-72 hours will be kept between applications to improve neuroplasticity changes' induction, which is estimated to reflect in the effect retention. Eight major evaluation points will be employed in 26 weeks, and a daily numeric rating scale (NRS) self-assessment.
The trial will potentially improve the quality of life, reduce the health burden caused by chronic orofacial pain, and provide further data on the use of tDCS in this setting, thus, enabling an additional route to manage the symptoms of pain in the future.
- Conditions
- Orofacial Pain
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Keywords
- Orofacial Pain, tDCS, trancranial DIrect Current Stimulation, NIBS, non-invasive brain stimulation
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes.
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
The sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | The investigators aim for six sessions of anodal stimulation over the right primary motor area contralateral to the orofacial pain (C3 or C4 in 10-20 EEG system) with cathode above the frontal area ipsilateral to the orofacial pain (Fp1 or Fp2) using HDCstim by Newronika S.r.l., Italy. The therapy will be administered over two weeks (Mon, Wed, Fri) to ensure a washout period of 48 to 72 hours between applications. The current of 2 mA will be delivered via silicone electrodes inserted into saline (0.9%) filled cellulose sponges, anode 5x5cm, cathode 6x8cm, for 20 minutes with 20 seconds of both ramp-up and ramp-down. An International 10-20 EEG system will be used to determine the stimulation location, and dedicated EEG caps will be used to ensure consistency between applications. Receives: Device: Transcranial Direct Current Stimulation |
| Sham group | Placebo comparator | The sham (placebo) will be administered using the same devices with a preprogrammed sham protocol (using HDCprog by Newronika S.r.l., Italy) of 20 minutes to be virtually indistinguishable from the active stimulation. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The McGill Pain Questionnaire (short form).
The Short-form McGill Pain Questionnaire is a standardized questionnaire assessing pain's sensory and affective dimensions. The types of pain are scaled as to their intensity between 1-4 (a higher value denotes higher intensity), the overall intensity is scaled between 0-5 (a higher value denotes higher intensity), and VAS is used to visualize the notion of pain (evaluated on a scale of 0-10, a higher value denotes higher intensity).
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in The McGill Pain Questionnaire (short form) at T2.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T3.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T3 (6 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T4.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T4 (10 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T5.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T5 (14 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T6.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T6 (18 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T7.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T7 (22 weeks since T1)
Changes in The McGill Pain Questionnaire (short form) at T8.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T8 (26 weeks since T1)
The numeric rating scale (NRS) as part of "pain diary"
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in the numeric rating scale (NRS) every day of them follow-up period.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Measured: Measured every day since T1 up until T8. (for 26 weeks in total)
The Margolis Pain Diagram
The Margolis pain diagram weights the extension and distribution of pain, expressed as the percentage of body surface in pain and its location. The tool consists of a dorsal and a ventral drawing of the body. The subjects are asked to shade areas in which they have experienced pain.
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in the Margolis Pain Diagram at T2.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in the Margolis Pain Diagram at T3.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T3 (6 weeks since T1)
Changes in the Margolis Pain Diagram at T4.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T4 (10 weeks since T1)
Changes in the Margolis Pain Diagram at T5.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T5 (14 weeks since T1)
Changes in the Margolis Pain Diagram at T6.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T6 (18 weeks since T1)
Changes in the Margolis Pain Diagram at T7.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T7 (22 weeks since T1)
Changes in the Margolis Pain Diagram at T8.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T8 (26 weeks since T1)
The questionnaire of interference with daily activities
A standardized questionnaire to evaluate the interference of pain with daily activities. Minimum=0 points, maximum=5 points. A higher score generally means more severe interference.
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in the questionnaire of interference with daily activities at T2.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in the questionnaire of interference with daily activities at T3.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T3 (6 weeks since T1)
Changes in the questionnaire of interference with daily activities at T4.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T4 (10 weeks since T1)
Changes in the questionnaire of interference with daily activities at T5.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T5 (14 weeks since T1)
Changes in the questionnaire of interference with daily activities at T6.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T6 (18 weeks since T1)
Changes in the questionnaire of interference with daily activities at T7.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T7 (22 weeks since T1)
Changes in the questionnaire of interference with daily activities at T8.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T8 (26 weeks since T1)
Secondary outcomes (16)
Beck's Depression Inventory (BDI)
A standardized questionnaire to evaluate the symptoms of depression. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in Beck's Depression Inventory (BDI) at T2.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T3.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T3 (6 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T4.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T4 (10 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T5.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T5 (14 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T6.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T6 (18 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T7.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T7 (22 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T8.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T8 (26 weeks since T1)
Beck Anxiety Inventory (BAI)
A standardized questionnaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety
Measured: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in Beck Anxiety Inventory (BAI) at T2.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T3.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T3 (6 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T4.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T4 (10 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T5.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T5 (14 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T6.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T6 (18 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T7.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T7 (22 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T8.
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Measured: Measured at T8 (26 weeks since T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start3 Oct 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: The study was not initiated; no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Prospective, randomized, double-blinded, placebo-controlled, two-arm trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadeáš Mareš, Charles University, Czech Republic
- Investigators
- Jitka Fricova, M.D., Ph.D., Study director, General University Hospital in Prague; Charles University in PragueTadeas Mares, M.D., Study chair, General University Hospital in Prague; Charles University in PragueMartin Anders, M.D., Ph.D., Study chair, General University Hospital in Prague; Charles University in PragueJozef Buday, M.D., Ph.D., Study chair, General University Hospital in Prague; Charles University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584384
- Sponsor's protocol ID
- 53/22 Grant AZV VES 2023VFN
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is to be shared on request by a verified researcher. The study director´s discretion is reserved.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain
- ClinicalTrials.gov ID
- NCT05584384
- Acronym / sponsor ID
- 53/22 Grant AZV VES 2023VFN
- Conditions
- Orofacial Pain
- Keywords
- Orofacial Pain, tDCS, trancranial DIrect Current Stimulation, NIBS, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated; no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 3 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Oct 2022 (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.
The trial´s main goal is to explore the use of transcranial direct current stimulation (tDCS) as a treatment option for persons suffering from orofacial pain. The aim of the trial is to further investigate the efficacy and longevity of tDCS in treating chronic pharmacoresistant orofacial pain.
A prospective, randomized, double-blinded, two-arm, sham-controlled design will be utilized. Primarily, the analgesic effect's intensity and duration will be assessed. Secondarily, the associated reduction of symptoms of anxiety and depression will be investigated, as well as the impact on the general quality of life. Anodal stimulation (6 sessions in 2 weeks, 2mA, 20 min, cathode over the opposite Fp area) of M1 contralateral to the pain location will be employed. Washout periods of 48-72 hours will be kept between applications to improve neuroplasticity changes' induction, which is estimated to reflect in the effect retention. Eight major evaluation points will be employed in 26 weeks, and a daily numeric rating scale (NRS) self-assessment.
The trial will potentially improve the quality of life, reduce the health burden caused by chronic orofacial pain, and provide further data on the use of tDCS in this setting, thus, enabling an additional route to manage the symptoms of pain in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blinded, placebo-controlled, two-arm trial.
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Device: Transcranial Direct Current StimulationThe investigators aim for six sessions of anodal stimulation over the right primary motor area contralateral to the orofacial pain (C3 or C4 in 10-20 EEG system) with cathode above the frontal area ipsilateral to the orofacial pain (Fp1 or Fp2) using HDCstim by Newronika S.r.l., Italy. The therapy will be administered over two weeks (Mon, Wed, Fri) to ensure a washout period of 48 to 72 hours between applications. The current of 2 mA will be delivered via silicone electrodes inserted into saline (0.9%) filled cellulose sponges, anode 5x5cm, cathode 6x8cm, for 20 minutes with 20 seconds of both ramp-up and ramp-down. An International 10-20 EEG system will be used to determine the stimulation location, and dedicated EEG caps will be used to ensure consistency between applications. |
| Sham group | Placebo comparator | Device: Sham Transcranial Direct Current StimulationThe sham (placebo) will be administered using the same devices with a preprogrammed sham protocol (using HDCprog by Newronika S.r.l., Italy) of 20 minutes to be virtually indistinguishable from the active stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Orofacial Pain by a pain medicine specialist according to ICOP (International classification of orofacial pain) and ICHD3 (International classification of headache disorder)
- Stable analgesic therapy one month before the stimulation series
Key exclusion criteria (3 listed)
- Changes to the analgesic therapy in 6 months following the stimulation series
- Non-compliance with the follow-ups
- General contraindications to tDCS - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses
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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSTranscranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes. | Device | Active group |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSThe sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation. | Device | Sham group |
Primary outcome
The McGill Pain Questionnaire (short form).
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
The Short-form McGill Pain Questionnaire is a standardized questionnaire assessing pain's sensory and affective dimensions. The types of pain are scaled as to their intensity between 1-4 (a higher value denotes higher intensity), the overall intensity is scaled between 0-5 (a higher value denotes higher intensity), and VAS is used to visualize the notion of pain (evaluated on a scale of 0-10, a higher value denotes higher intensity).
Changes in The McGill Pain Questionnaire (short form) at T2.
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T3.
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T4.
Time frame: Measured at T4 (10 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T5.
Time frame: Measured at T5 (14 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T6.
Time frame: Measured at T6 (18 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T7.
Time frame: Measured at T7 (22 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in The McGill Pain Questionnaire (short form) at T8.
Time frame: Measured at T8 (26 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
The numeric rating scale (NRS) as part of "pain diary"
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Changes in the numeric rating scale (NRS) every day of them follow-up period.
Time frame: Measured every day since T1 up until T8. (for 26 weeks in total)
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
The Margolis Pain Diagram
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
The Margolis pain diagram weights the extension and distribution of pain, expressed as the percentage of body surface in pain and its location. The tool consists of a dorsal and a ventral drawing of the body. The subjects are asked to shade areas in which they have experienced pain.
Changes in the Margolis Pain Diagram at T2.
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T3.
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T4.
Time frame: Measured at T4 (10 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T5.
Time frame: Measured at T5 (14 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T6.
Time frame: Measured at T6 (18 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T7.
Time frame: Measured at T7 (22 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the Margolis Pain Diagram at T8.
Time frame: Measured at T8 (26 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
The questionnaire of interference with daily activities
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
A standardized questionnaire to evaluate the interference of pain with daily activities. Minimum=0 points, maximum=5 points. A higher score generally means more severe interference.
Changes in the questionnaire of interference with daily activities at T2.
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T3.
Time frame: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T4.
Time frame: Measured at T4 (10 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T5.
Time frame: Measured at T5 (14 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T6.
Time frame: Measured at T6 (18 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T7.
Time frame: Measured at T7 (22 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
Changes in the questionnaire of interference with daily activities at T8.
Time frame: Measured at T8 (26 weeks since T1)
Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement
16 secondary outcomes
Beck's Depression Inventory (BDI)
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in Beck's Depression Inventory (BDI) at T2.
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T3.
Time frame: Measured at T3 (6 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T4.
Time frame: Measured at T4 (10 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T5.
Time frame: Measured at T5 (14 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T6.
Time frame: Measured at T6 (18 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T7.
Time frame: Measured at T7 (22 weeks since T1)
Changes in Beck's Depression Inventory (BDI) at T8.
Time frame: Measured at T8 (26 weeks since T1)
Beck Anxiety Inventory (BAI)
Time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
Changes in Beck Anxiety Inventory (BAI) at T2.
Time frame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T3.
Time frame: Measured at T3 (6 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T4.
Time frame: Measured at T4 (10 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T5.
Time frame: Measured at T5 (14 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T6.
Time frame: Measured at T6 (18 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T7.
Time frame: Measured at T7 (22 weeks since T1)
Changes in Beck Anxiety Inventory (BAI) at T8.
Time frame: Measured at T8 (26 weeks since T1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD is to be shared on request by a verified researcher. The study director´s discretion is reserved.
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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. This study is not recruiting at the moment.
Jitka Fricova, M.D., Ph.D. study director
General University Hospital in Prague; Charles University in Prague
Tadeas Mares, M.D. study chair
General University Hospital in Prague; Charles University in Prague
Martin Anders, M.D., Ph.D. study chair
General University Hospital in Prague; Charles University in Prague
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Orofacial Pain, run by Charles University, Czech Republic.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The McGill Pain Questionnaire (short form). (time frame: The measurement will be established as a baseline prior to the stimulation series. (at T1)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.