Trial Outcomes & Findings for LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE (NCT NCT04141046)
NCT ID: NCT04141046
Last Updated: 2024-06-27
Results Overview
Change in alpha oscillation power (8-12 Hz) will be measured between resting state electroencephalogram (RSEEG) recordings.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Day 1, Day 5
Results posted on
2024-06-27
Participant Flow
No participants were randomized to the Theta-tACS arm.
Participant milestones
| Measure |
Sham Stimulation
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with Transcranial Alternating Current Stimulation (tACS) to enhance success of patient blinding.
XCSITE100 Stimulator - Active Sham: 20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
|
Theta-tACS
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.
XCSITE100 Stimulator - Individualized theta-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Alpha-tACS
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.
XCSITE100 Stimulator - Individualized alpha-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
3
|
|
Overall Study
COMPLETED
|
1
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE
Baseline characteristics by cohort
| Measure |
Sham Stimulation
n=1 Participants
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.
XCSITE100 Stimulator - Active Sham: 20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
|
Theta-tACS
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.
XCSITE100 Stimulator - Individualized theta-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Alpha-tACS
n=3 Participants
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.
XCSITE100 Stimulator - Individualized alpha-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 5Population: No participants were randomized to the Theta-tACS arm.
Change in alpha oscillation power (8-12 Hz) will be measured between resting state electroencephalogram (RSEEG) recordings.
Outcome measures
| Measure |
Sham Stimulation
n=1 Participants
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.
XCSITE100 Stimulator - Active Sham: 20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
|
Theta-tACS
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.
XCSITE100 Stimulator - Individualized theta-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Alpha-tACS
n=3 Participants
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.
XCSITE100 Stimulator - Individualized alpha-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
|---|---|---|---|
|
Change in Alpha Oscillation Power as Measured by RSEEG Recordings.
|
0.146 microvolts^2/Hz
|
—
|
-0.015 microvolts^2/Hz
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Inventory of Depression and Anxiety Symptoms (IDAS) Scale is a 10 symptom scale (General depression, Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions) used to assess depression and anxiety related disorders. The scale ranges from 1 to 5 with 1 equal to "not at all" and 5 equal to"extremely". Higher scores indicate a greater experience of a given symptom.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Positive and Negative Affect Schedule (PANAS) will be used to measure positive and negative emotion. This 20-item self-reported survey will measure 10 positive and 10 negative affective states. Positive affect score ranges from 10-50 and higher scores indicate a greater positive affect. Negative affect scores range from 10-50 with higher scores indicating a greater negative affect.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Comparative Pain Scale score will assess for self-reported pain. The scale ranges from 0 to 10, with 0 equal to "pain free" and 10 equal to "unmanageable, unspeakable". Higher scores reflect a higher severity of self-reported pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, 4 weekPopulation: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The 36-Item Short Form Health Survey (SF-36) measures general health using 36 questions. There are 8 individual health "domains" or categories that each receive their own score, and from these 8 individual scores an overall score can be obtained. Overall scores can range from 0-100, with higher scores indicating better overall health.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Fatigue Scale for Motor and Cognitive Functions (FSMC) will measure self-reported levels of physical and mental fatigue. This 20-item survey will measure 10 motor fatigue items and 10 cognitive fatigue items. The scale ranges from 1 to 5 with 1 equal to "does not apply at all" and 5 equal to "applies completely". Total scores can range from 20 to 100 with higher scores indicating worse fatigue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Pain Catastrophizing Scale (PCS) will assess for self-reported pain. The survey consists of 13 items with a 5-point scale, where 0 equals"not at all" and 4 equals "all the time". Total scores can range from 0 to 52 with higher scores indicating a greater frequency in which individuals experience pain-related thoughts and feelings.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Young Mania Rating Scale (YMRS) will assess for manic symptoms at baseline and over the period of the study. The 11 item scale ranges from 0 to 56 with higher scores indicating more severe manic symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Hamilton Depression Rating Scale (HDRS17) will assess for the severity of depressive symptoms in the patients. The scale ranges from 0 to 52 with higher scores indicating a greater severity of depressive symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Day 5Population: Insufficient data were collected to validly calculate a correlation as stated in the statistical analysis plan.
The Hamilton Anxiety (HAM-A) scale will assess for the severity of anxiety symptoms. The scale ranges from 0 to 30 with higher scores indicating greater anxiety.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 5Participants will complete various tasks paired with electroencephalogram (EEG) recordings to assess physiological changes. Participants will be asked to perform sustained attention, selective attention, and working memory tasks with EEG recordings.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, 3 monthThe World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will assess for co morbid disabilities. This 12-item survey ranges from 0 to 4 with 0 being "none" and 4 being "extreme or cannot do". Total scores can range from 0 to 48 with higher scores lower levels of social functioning.
Outcome measures
Outcome data not reported
Adverse Events
Sham Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Theta-tACS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alpha-tACS
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Stimulation
n=1 participants at risk
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.
XCSITE100 Stimulator - Active Sham: 20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
|
Theta-tACS
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.
XCSITE100 Stimulator - Individualized theta-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Alpha-tACS
n=3 participants at risk
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.
XCSITE100 Stimulator - Individualized alpha-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
|---|---|---|---|
|
Nervous system disorders
Vasovagal response
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Newly Diagnosed Basal Cell Carcinoma
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
Other adverse events
| Measure |
Sham Stimulation
n=1 participants at risk
This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.
XCSITE100 Stimulator - Active Sham: 20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
|
Theta-tACS
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.
XCSITE100 Stimulator - Individualized theta-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
Alpha-tACS
n=3 participants at risk
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.
XCSITE100 Stimulator - Individualized alpha-tACS: 20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Laceration from pet claw
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
0.00%
0/3 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Vascular disorders
Elevated Blood pressure
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
|
Renal and urinary disorders
Elevated Urine Protein
|
0.00%
0/1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
—
0/0 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 3 months.
No participants were randomized to the Theta-tACS arm. In addition to the standard ClinicalTrials.gov Serious Adverse Event definition, the study also defined an adverse event of grade 3 or higher as determined by the U.S. Department of Health and Human Services' Common Terminology Criteria for Adverse Events (CTCAE Version 5.0 Published: November 27th, 2017) as a Serious Adverse Event.
|
Additional Information
Saira Sheikh, MD
University of North Carolina at Chapel Hill
Phone: 919-966-0545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place