The Use of tDCS in the Orofacial Pain

Charles University, Czech Republic

Status: Enrolling

Conditions: Orofacial Pain

Treatments: Device: Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05584384

53/22 Grant AZV VES 2023VFN

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Active group

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham group

Placebo Comparator group

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation