Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-10-03
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active group
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.
Transcranial Direct Current Stimulation
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 group
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.
Sham Transcranial Direct Current Stimulation
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.
Interventions
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Transcranial Direct Current Stimulation
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 Stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable analgesic therapy one month before the stimulation series
Exclusion Criteria
* Non-compliance with the follow-ups
* General contraindications to tDCS - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses
18 Years
75 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Responsible Party
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Tadeáš Mareš
Head of tDCS lab
Principal Investigators
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Jitka Fricova, M.D., Ph.D.
Role: STUDY_DIRECTOR
General University Hospital in Prague; Charles University in Prague
Tadeas Mares, M.D.
Role: STUDY_CHAIR
General University Hospital in Prague; Charles University in Prague
Martin Anders, M.D., Ph.D.
Role: STUDY_CHAIR
General University Hospital in Prague; Charles University in Prague
Jozef Buday, M.D., Ph.D.
Role: STUDY_CHAIR
General University Hospital in Prague; Charles University in Prague
Locations
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Pain Management Centre, General University Hospital in Prague; Charles University in Prague
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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53/22 Grant AZV VES 2023VFN
Identifier Type: -
Identifier Source: org_study_id
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