Clinical trial NCT05613582: The Effectiveness of Transcranial Direct Current Stimulation as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus
Official title: The Effectiveness of Transcranial Direct Current Stimulation (tDCS) as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus: A Double Blind Randomized Multi-Arm Sham Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Chronic Headache
Keywords: Systemic Lupus Erythematosus
Chronic Headache
Transcranial Direct Current Stimulation
Double-Blind Study
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study aimed to assess the effectiveness of the tDCS protocol as an adjuvant therapy for reducing chronic headache in SLE. It is also hoped that this study will obtain an effective tDCS protocol for chronic headache.

The whole procedure will run for 20 weeks, divided into 3 parts (Pre-intervention, Intervention, and Post-intervention)

Pre-intervention (weeks 0-4) to conduct screening, provide informed consent, and also baseline assessment. Participants will come in weeks 0 and 4.

Intervention (weeks 4-8) to perform the TDCS intervention, record and assess outcomes, and assess if an unwanted event occurs. Participants will come 2 times per week, from week 4 to 8

Post-intervention (weeks 8-20) for continued outcome assessment. Participants will come on weeks 8, 12, 16, and 20

The total number of visits from each participant is 14 times

SLE patients who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment (weeks 0-4) followed by randomization into 4 groups/arms consisting of 3 treatments (getting standard therapy for SLE and other diseases that have been obtained so far, plus the administration of tDCS at DLPC, M1, S1) and 1 control group that got sham tDCS.

If the tDCS intervention shows effective and safe results, then the subject in the control group (the group that received the sham) will be offered to be given the intervention method at the end of the study.

Any unwanted event (adverse event) that occurs will be recorded. If an undesirable event occurs, a written report will be made to the ethics committee.

Demographic data will be presented descriptively according to the type of data. Normality test will be performed with Shapiro-Wilkins. To find out the changes in the frequency of headaches in the four groups, an analysis using one-way Anova was carried out followed by Bonferroni post hoc analysis with a significance level of 0.05. The effect size of each group will also be analyzed with Cohen's d=02 (small effect), 0.5 (medium) and 0.8 (large) parameters.

Data analysis will be carried out using SPSS 23.0 and GraphPad software.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Patients who have been diagnosed with SLE based on the 2019 ACR criteria
3. Meet 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:

1. The patient or the patient's family refuses to participate in the study
2. Is in a state of relapse/flare
3. Allergic reactions / skin infections / wounds / cranial defects / metal implants in the electrode installation area
4. Have a history of brain tumor, severe head injury, stroke

Primary outcomes:
measure: Headache Frequency
timeFrame: Change from baseline, at the end of weeks 8, and during the follow up period (end of weeks 12, 16, and 20)
Secondary outcomes:
measure: Headache Assessed by Visual Analouge Scale
timeFrame: Change from baseline, 4th, 5th-8th, 12th, 16th, 20th week
measure: Functional Aspects of Headache-Related Quality of Life Assessed by Chronic Headache Quality of Life Questionnaire (CHQLQ)
timeFrame: 4th, 8th, 12th, 16th, 20th week
measure: Health-Related Quality of Life Assessed by The 36-Item Short Form Health Survey Questionnaire (SF-36)
timeFrame: 4th, 8th, 12th, 16th, 20th week
measure: Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4th, 8th, 12th, 16th, 20th week
measure: Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD 10)
timeFrame: 4th, 8th, 12th, 16th, 20th week
measure: Frequency of use of analgesics
timeFrame: Change from baseline until week 8th, followed at 12th, 16th, 20th week
measure: Amount of analgesic use
timeFrame: Change from baseline until week 8th, followed at 12th, 16th, 20th week
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Riwanti Estiasari, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: