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

NCT ID: NCT05613582

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-09-20

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.

Conditions

Systemic Lupus Erythematosus; Chronic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Primary Motor Cortex (M1)

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.

Primary Sensory Cortex (S1)

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.

Dorsolateral Prefrontal Cortex (DLPFC)

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.

Sham

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.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.

Interventions

Transcranial Direct Current Stimulation

The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Riwanti Estiasari, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riwanti Estiasari, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Central Contacts

Dyah Tunjungsari, MD

Role: CONTACT

penelitian.neuroui@gmail.com

+628119884224

References

Estiasari R, Tiksnadi A, Tunjungsari D, Maharani K, Aninditha T, Sofyan HR, Savitri I, Pangeran D, Jeremia I, Widhani A, Ariane A. Effectiveness of transcranial direct current stimulation (tDCS) as adjunctive treatment for chronic headache in adults with clinically stable systemic lupus erythematosus (SHADE): a randomised double-blind multiarm sham controlled clinical trial. BMJ Open. 2023 Dec 14;13(12):e076713. doi: 10.1136/bmjopen-2023-076713.

Reference Type: DERIVED

PMID: 38101851 (View on PubMed)

Other Identifiers

22070753

Identifier Type: -

Identifier Source: org_study_id