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NCT05613582
The Effectiveness of Transcranial Direct Current Stimulation as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus
Conditions: Systemic Lupus Erythematosus, Chronic Headache
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 88
Sponsor: Indonesia University
Summary
The prevalence of chronic primary headache in Systemic Lupus Erythematosus (SLE) is 54.4%.
Several studies have shown that the use of transcranial direct current stimulation (tDCS) at the primary motor cortex (M1), primary sensory cortex (S1), or dorsolateral prefrontal cortex (DLPFC) is effective as adjuvant therapy in primary headache.
Using a double-blind design, this clinical trial study will investigate the effectiveness of tDCS as an adjuvant therapy in chronic daily headaches in SLE, by also comparing the effectiveness of administration in the M1, S1, and DLPFC.The primary endpoint that will be assessed is the frequency of headaches per week, with the secondary endpoints are the degree of headache, quality of life, sleep quality, level of depression, and use of analgesics.
Eligibility Criteria
Inclusion Criteria:Age > 18 years oldPatients who have been diagnosed with SLE based on the 2019 ACR criteriaMeet the criteria for the diagnosis of chronic headache (criteria based on the International Headache Society, headache occurs in 15 days or more per month, occurs for at least 3 months)Exclusion Criteria:The patient or the patient's family refuses to participate in the studyIs in a state of relapse/flareAllergic reactions / skin infections / wounds / cranial defects / metal implants in the electrode installation areaHave a history of brain tumor, severe head injury, stroke
Source: ClinicalTrials.gov (NCT05613582). StuddyBuddy aggregates publicly available trial information.