The Use of tDCS in the Orofacial Pain

Last updated: February 20, 2024
Sponsor: Charles University, Czech Republic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Oral Medicine

Neuropathic Facial Pain

Treatment

Sham Transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation

Clinical Study ID

NCT05584384
53/22 Grant AZV VES 2023VFN
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Orofacial Pain by a pain medicine specialist according to ICOP (International classification of orofacial pain) and ICHD3 (Internationalclassification of headache disorder)
  • Stable analgesic therapy one month before the stimulation series

Exclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Sham Transcranial Direct Current Stimulation
Phase:
Study Start date:
October 03, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

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

    Praha, 12000
    Czechia

    Active - Recruiting

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