Systemic Lupus ErythematosusSHADENCT05613582
The Effectiveness of Transcranial Direct Current Stimulation as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus
A study testing Transcranial Direct Current Stimulation in people with Systemic Lupus Erythematosus and Chronic Headache, run by Universitas Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Chronic Headache
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Systemic Lupus Erythematosus, Chronic Headache, Transcranial Direct Current Stimulation, Double-Blind Study
- Medical subject headings
- Lupus Erythematosus, Systemic, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
The flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system.
| Study group | Role | What they receive |
|---|---|---|
| Primary Motor Cortex (M1) | Experimental | Subjects were randomly assigned to receive tDCS stimulation at the primary motor cortex (M1) Receives: Device: Transcranial Direct Current Stimulation |
| Primary Sensory Cortex (S1) | Experimental | Subjects were randomly assigned to receive tDCS stimulation at the primary sensory cortex (S1) Receives: Device: Transcranial Direct Current Stimulation |
| Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Subjects were randomly assigned to receive tDCS stimulation at the dorsolateral prefrontal cortex (DLPFC) Receives: 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency
Headache Frequency will be assessed using the headache diary, with a reduced number of frequencies, it indicates a better output
Measured: 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
Minimum value: 0 cm Maximum value: 10 cm Assessment using a straight line 10 cm long. Both ends showed signs at 0 cm not painful and the other end at 10 cm very painful. The patient then marks along the line that interprets the pain.
Measured: 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)
Lowest score 0 Highest score 300 The higher the value, the worse the outcome
Measured: 4th, 8th, 12th, 16th, 20th week
Health-Related Quality of Life Assessed by The 36-Item Short Form Health Survey Questionnaire (SF-36)
Lowest score: 0 Highest score: 100 Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales
Measured: 4th, 8th, 12th, 16th, 20th week
Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Lowest score: 0 Highest score: 21 The higher the value, the worse the outcome
Measured: 4th, 8th, 12th, 16th, 20th week
Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD 10)
Will be assessed whether the subject has a depressive episode (Yes/No)
Measured: 4th, 8th, 12th, 16th, 20th week
Frequency of use of analgesics
Assessment using records of frequency of analgesic consumption
Measured: Change from baseline until week 8th, followed at 12th, 16th, 20th week
Amount of analgesic use
Assessment using records of frequency of amount of analgesic use
Measured: Change from baseline until week 8th, followed at 12th, 16th, 20th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start20 Nov 2022 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riwanti Estiasari, MD, PhD, Universitas Indonesia
- Investigators
- Riwanti Estiasari, MD, PHD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613582
- Sponsor's protocol ID
- 22070753
- Acronym
- SHADE
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38101851
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05613582
- Acronym / sponsor ID
- SHADE / 22070753
- Conditions
- Systemic Lupus Erythematosus, Chronic Headache
- Keywords
- Systemic Lupus Erythematosus, Chronic Headache, Transcranial Direct Current Stimulation, Double-Blind Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Motor Cortex (M1) | Experimental | Device: Transcranial Direct Current StimulationSubjects were randomly assigned to receive tDCS stimulation at the primary motor cortex (M1) |
| Primary Sensory Cortex (S1) | Experimental | Device: Transcranial Direct Current StimulationSubjects were randomly assigned to receive tDCS stimulation at the primary sensory cortex (S1) |
| Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Device: Transcranial Direct Current StimulationSubjects were randomly assigned to receive tDCS stimulation at the dorsolateral prefrontal cortex (DLPFC) |
| Sham | Sham comparator | Device: Transcranial Direct Current StimulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationThe flow of DC electric current 1 mA for 20 minutes. The position of the electrode placement follows the international EEG 10/20 system. | Device | Dorsolateral Prefrontal Cortex (DLPFC), Primary Motor Cortex (M1), Primary Sensory Cortex (S1), Sham |
Primary outcome
Headache Frequency
Time frame: Change from baseline, at the end of weeks 8, and during the follow up period (end of weeks 12, 16, and 20)
Headache Frequency will be assessed using the headache diary, with a reduced number of frequencies, it indicates a better output
7 secondary outcomes
Headache Assessed by Visual Analouge Scale
Time frame: 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)
Time frame: 4th, 8th, 12th, 16th, 20th week
Health-Related Quality of Life Assessed by The 36-Item Short Form Health Survey Questionnaire (SF-36)
Time frame: 4th, 8th, 12th, 16th, 20th week
Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4th, 8th, 12th, 16th, 20th week
Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD 10)
Time frame: 4th, 8th, 12th, 16th, 20th week
Frequency of use of analgesics
Time frame: Change from baseline until week 8th, followed at 12th, 16th, 20th week
Amount of analgesic use
Time frame: Change from baseline until week 8th, followed at 12th, 16th, 20th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 38101851Estiasari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riwanti Estiasari, MD, PHD principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Systemic Lupus Erythematosus and Chronic Headache, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dyah Tunjungsari, MD (+628119884224, penelitian.neuroui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Frequency (time frame: Change from baseline, at the end of weeks 8, and during the follow up period (end of weeks 12, 16, and 20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.