The Effectiveness of Transcranial Direct Current Stimulation as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus (SHADE)

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Chronic Headache; Systemic Lupus Erythematosus

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05613582

22070753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 4 patient groups

Primary Motor Cortex (M1)

Experimental group

Description:

Subjects were randomly assigned to receive tDCS stimulation at the primary motor cortex (M1)

Treatment:

Device: Transcranial Direct Current Stimulation

Primary Sensory Cortex (S1)

Experimental group

Description:

Subjects were randomly assigned to receive tDCS stimulation at the primary sensory cortex (S1)

Treatment:

Device: Transcranial Direct Current Stimulation

Dorsolateral Prefrontal Cortex (DLPFC)

Experimental group

Description:

Subjects were randomly assigned to receive tDCS stimulation at the dorsolateral prefrontal cortex (DLPFC)

Treatment:

Device: Transcranial Direct Current Stimulation

Sham

Sham Comparator group

Description:

The sham intervention procedure was carried out similarly to the experimental group, but in the following group, the device would only conduct electric current in the first and last 30 seconds of the intervention.

Treatment:

Device: Transcranial Direct Current Stimulation