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The Use of tDCS in the Orofacial Pain

Primary Purpose

Orofacial Pain

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orofacial Pain focused on measuring Orofacial Pain, tDCS, trancranial DIrect Current Stimulation, NIBS, non-invasive brain stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pain Management Centre, General University Hospital in Prague; Charles University in PragueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active group

Sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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
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
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
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
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
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
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
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.
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.
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.
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
October 14, 2022
Last Updated
October 14, 2022
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05584384
Brief Title
The Use of tDCS in the Orofacial Pain
Official Title
The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orofacial Pain
Keywords
Orofacial Pain, tDCS, trancranial DIrect Current Stimulation, NIBS, non-invasive brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double-blinded, placebo-controlled, two-arm trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participants will be distributed between 2 arms using an aperiodic, nondeterministic, atmospheric random noise randomization algorithm. The stimulation type will be unblinded upon completing all the follow-ups or dropping out. The blinding will be ensured by a dedicated team member with no direct access to the participants or their data.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
The McGill Pain Questionnaire (short form).
Description
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).
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T2.
Description
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
Time Frame
Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T3.
Description
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
Time Frame
Measured at T3 (6 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T4.
Description
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
Time Frame
Measured at T4 (10 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T5.
Description
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
Time Frame
Measured at T5 (14 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T6.
Description
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
Time Frame
Measured at T6 (18 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T7.
Description
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
Time Frame
Measured at T7 (22 weeks since T1)
Title
Changes in The McGill Pain Questionnaire (short form) at T8.
Description
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
Time Frame
Measured at T8 (26 weeks since T1)
Title
The numeric rating scale (NRS) as part of "pain diary"
Description
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.
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in the numeric rating scale (NRS) every day of them follow-up period.
Description
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.
Time Frame
Measured every day since T1 up until T8. (for 26 weeks in total)
Title
The Margolis Pain Diagram
Description
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.
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in the Margolis Pain Diagram at T2.
Description
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
Time Frame
Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T3.
Description
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
Time Frame
Measured at T3 (6 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T4.
Description
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
Time Frame
Measured at T4 (10 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T5.
Description
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
Time Frame
Measured at T5 (14 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T6.
Description
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
Time Frame
Measured at T6 (18 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T7.
Description
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
Time Frame
Measured at T7 (22 weeks since T1)
Title
Changes in the Margolis Pain Diagram at T8.
Description
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
Time Frame
Measured at T8 (26 weeks since T1)
Title
The questionnaire of interference with daily activities
Description
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.
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in the questionnaire of interference with daily activities at T2.
Description
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
Time Frame
Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T3.
Description
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
Time Frame
Measured at T3 (6 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T4.
Description
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
Time Frame
Measured at T4 (10 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T5.
Description
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
Time Frame
Measured at T5 (14 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T6.
Description
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
Time Frame
Measured at T6 (18 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T7.
Description
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
Time Frame
Measured at T7 (22 weeks since T1)
Title
Changes in the questionnaire of interference with daily activities at T8.
Description
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
Time Frame
Measured at T8 (26 weeks since T1)
Secondary Outcome Measure Information:
Title
Beck's Depression Inventory (BDI)
Description
A standardized questionnaire to evaluate the symptoms of depression. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in Beck's Depression Inventory (BDI) at T2.
Description
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
Time Frame
Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T3.
Description
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
Time Frame
Measured at T3 (6 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T4.
Description
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
Time Frame
Measured at T4 (10 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T5.
Description
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
Time Frame
Measured at T5 (14 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T6.
Description
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
Time Frame
Measured at T6 (18 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T7.
Description
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
Time Frame
Measured at T7 (22 weeks since T1)
Title
Changes in Beck's Depression Inventory (BDI) at T8.
Description
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
Time Frame
Measured at T8 (26 weeks since T1)
Title
Beck Anxiety Inventory (BAI)
Description
A standardized questionnaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety
Time Frame
The measurement will be established as a baseline prior to the stimulation series. (at T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T2.
Description
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
Time Frame
Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T3.
Description
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
Time Frame
Measured at T3 (6 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T4.
Description
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
Time Frame
Measured at T4 (10 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T5.
Description
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
Time Frame
Measured at T5 (14 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T6.
Description
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
Time Frame
Measured at T6 (18 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T7.
Description
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
Time Frame
Measured at T7 (22 weeks since T1)
Title
Changes in Beck Anxiety Inventory (BAI) at T8.
Description
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
Time Frame
Measured at T8 (26 weeks since T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jitka Fricova, M.D., Ph.D.
Phone
0042022496 6370
Email
jitka.fricova@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitka Fricova, M.D., Ph.D.
Organizational Affiliation
General University Hospital in Prague; Charles University in Prague
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tadeas Mares, M.D.
Organizational Affiliation
General University Hospital in Prague; Charles University in Prague
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Anders, M.D., Ph.D.
Organizational Affiliation
General University Hospital in Prague; Charles University in Prague
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jozef Buday, M.D., Ph.D.
Organizational Affiliation
General University Hospital in Prague; Charles University in Prague
Official's Role
Study Chair
Facility Information:
Facility Name
Pain Management Centre, General University Hospital in Prague; Charles University in Prague
City
Praha
ZIP/Postal Code
12000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jitka Fricova, M.D., Ph.D.
Phone
00420224966370
Email
jitka.fricova@vfn.cz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is to be shared on request by a verified researcher. The study director´s discretion is reserved.
IPD Sharing Time Frame
When the results are published, indefinitely.
IPD Sharing Access Criteria
Verified researchers only.

Learn more about this trial

The Use of tDCS in the Orofacial Pain

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