The Use of tDCS in the Orofacial Pain

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.

Conditions

• Orofacial Pain

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Charles University, Czech Republic

  lead OTHER

Principal Investigators

• Jitka Fricova, M.D., Ph.D. · General University Hospital in Prague; Charles University in Prague

• Tadeas Mares, M.D. · General University Hospital in Prague; Charles University in Prague

• Martin Anders, M.D., Ph.D. · General University Hospital in Prague; Charles University in Prague

• Jozef Buday, M.D., Ph.D. · General University Hospital in Prague; Charles University in Prague

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-03

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Czechia

Study Locations