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

NCT05613582 | Unknown DMC

• 1 other identifier: 22070753
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus; Chronic Headache

Keywords

Systemic Lupus Erythematosus; Chronic Headache; Transcranial Direct Current Stimulation; Double-Blind Study

Outcome Measures

Primary Outcomes (1)

• Headache Frequency

  Headache Frequency will be assessed using the headache diary, with a reduced number of frequencies, it indicates a better output

  Change from baseline, at the end of weeks 8, and during the follow up period (end of weeks 12, 16, and 20)

Secondary Outcomes (7)

• Headache Assessed by Visual Analouge Scale

  Change from baseline, 4th, 5th-8th, 12th, 16th, 20th week

• Functional Aspects of Headache-Related Quality of Life Assessed by Chronic Headache Quality of Life Questionnaire (CHQLQ)

  4th, 8th, 12th, 16th, 20th week

• Health-Related Quality of Life Assessed by The 36-Item Short Form Health Survey Questionnaire (SF-36)

  4th, 8th, 12th, 16th, 20th week

• Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

  4th, 8th, 12th, 16th, 20th week

• Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD 10)

  4th, 8th, 12th, 16th, 20th week

Study Arms (4)

Primary Motor Cortex (M1)

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Primary Sensory Cortex (S1)

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Dorsolateral Prefrontal Cortex (DLPFC)

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Sham

SHAM COMPARATOR

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation 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); Primary Motor Cortex (M1); Primary Sensory Cortex (S1); Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Patients who have been diagnosed with SLE based on the 2019 ACR criteria
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Related Publications (1)

• 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.

  PMID: 38101851 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Headache Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Riwanti Estiasari, MD, PHD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dyah Tunjungsari, MD

CONTACT

+628119884224; penelitian.neuroui@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 14, 2022
• Study Start: November 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: September 20, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share