NCT05584384

The Use of tDCS in the Orofacial Pain

The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-10-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-18
• Last updated: 2024-02-21

Locations

1 site across 1 country: Czechia