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Behavioural Intervention
tACS for Depression in Lupus
N/A
Recruiting
Led By Saira Z Sheikh, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 5
Awards & highlights
Study Summary
This trial will help researchers understand if tACS can help relieve depression in patients with SLE, which may help improve their quality of life.
Who is the study for?
This trial is for adults aged 18-65 with systemic lupus erythematosus (SLE) who are also dealing with depression but not at high risk of suicide. Participants must have been stable on SLE and psychiatric medications for six weeks, understand the study's risks and benefits, and not be in a manic episode. Exclusions include those with certain medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests non-invasive brain stimulation using tACS to see if it can reduce depression symptoms in SLE patients. It explores whether this treatment can also alleviate chronic pain and cognitive issues associated with both SLE and depression.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode sites, mild headaches, dizziness, or tingling sensations during stimulation. There might also be temporary changes in mood or alertness levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in alpha oscillation power as measured by RSEEG recordings.
Secondary outcome measures
Change in correlation between the Comparative Pain Scale score and alpha oscillation power (as measured by resting state EEG recordings).
Change in correlation between the FSMC score and alpha oscillation power (as measured by resting state EEG recordings).
Change in correlation between the HAM-A score and alpha oscillation power (as measured by resting state EEG recordings).
+6 moreOther outcome measures
Change in correlation between frontal midline alpha and theta activity (as measured from EEG recordings) and accuracy at cognitive tasks tasks.
Change in the WHODAS 2.0 score.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Alpha-tACSExperimental Treatment1 Intervention
This arm targets alpha oscillations in the somatosensory cortex to see if there is a decrease in the experience of depression, pain, or brain fog in lupus patients.
Group II: Theta-tACSActive Control1 Intervention
This arm targets theta oscillations in the somatosensory cortex to see if there is a decrease in the experience of depression, pain, or brain fog in lupus patients.
Group III: Sham StimulationPlacebo Group1 Intervention
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,590 Total Patients Enrolled
Saira Z Sheikh, MDPrincipal InvestigatorUNC Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a low risk of attempting suicide.You have been diagnosed with drug or alcohol abuse in the past month, drug or alcohol dependence in the past 6 months, bipolar disorder, or a psychotic disorder.You have a history of certain brain-related conditions like seizures, dementia, stroke, Parkinson's disease, multiple sclerosis, or brain injury. You also have frequent or severe migraines in the past month.You have been diagnosed with systemic lupus erythematosus (SLE).You have taken high doses of intravenous glucocorticoids in the past month or are currently using benzodiazepines or anti-epileptic drugs.You have been diagnosed with a drug-induced lupus or any other rheumatologic or autoimmune disease, except for Sjogren's syndrome and mixed connective tissue disease.You have a serious medical condition (such as heart disease, AIDS, liver or kidney problems, or cancer within the past 5 years) or are receiving treatment for such a condition that may affect your ability to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Alpha-tACS
- Group 2: Theta-tACS
- Group 3: Sham Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the number of individuals participating in this investigation?
"That is correct. According to clinicaltrials.gov, this medical research began on January 1st 2019 and was last updated in March 2022. Presently, 72 individuals are being sought out at a single facility for participation in the trial."
Answered by AI
Is there eligibility criteria for me to join this clinical trial?
"Eligible enrollees for this clinical research must suffer from depression and have a birthdate between 18 and 65. The targeted size of the study is 72 participants."
Answered by AI
Are there any vacant enrolment spots available in this research protocol?
"Indeed, clinicaltrials.gov shows that this investigation is actively recruiting participants as of now. This research was first posted on January 1st 2019 with the latest edits occurring in March 7th 2022. The trial necessitates 72 patients to be enrolled from one location."
Answered by AI
Are individuals aged above 30 permitted to participate in the experiment?
"The requirements for this clinical trial stipulate that only applicants between the age of 18 and 65 can qualify. Furthermore, there are 234 trials targeting those younger than 18 years old and 1,601 studies addressing older patients above the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
West Virginia
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
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