An interventional study of XCSITE100 Stimulator Sham and XCSITE100 Stimulator tACS in Depression, Major Depressive Disorder and Premenstrual Dysphoric Disorder, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science
Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders.
Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions.
Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).
Participants will report for a study visit and will review and sign a consent form.
Participants will complete several clinical assessments and also take a urine drug test and urine pregnancy test (if applicable). Eligibility will be re-assessed by the investigators before the participant moves on to the next phase.
If the participant still qualifies, the participant will first be fitted with two 5x5cm electrodes placed over F3/F4 (10-20 measurement system) and one 5x7cm electrode placed over Cz. In addition, the participant will have a 128-channel EEG net placed on their head. Participants will provide a saliva sample to assess for brain-derived neurotrophic factor (BDNF), which may affect how the participant's brain responds to stimulation. Once the participant is fitted with this equipment, the participant will complete two interactive EEG tasks, then 2-minute resting state EEG with the participant's eyes closed, then a 5-minute resting state EEG with the participant's eyes open.
Following these recordings, participants will respond to additional questionnaires. Immediately following this, the participant will receive 40 minutes of stimulation (tACS or sham tACS). During this stimulation, participants will sit comfortably upright and awake.
After stimulation has completed, participants will respond to additional questionnaires. Once completed, participants will then complete an additional 5-minute resting state EEG with the participant's eyes open, as well as complete one of the additional interactive EEG tasks.
Finally, participants will respond to a blinding questionnaire to assess if the participant thought that the participant received stimulation. Once complete, the participant will leave. This session is estimated to last about 4 hours.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 84 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for individuals with depressed mood:
Exclusion Criteria for individuals with depressed mood:
Inclusion Criteria for healthy controls:
Exclusion Criteria for healthy controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
Device: XCSITE100 Stimulator tACS
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.
Device: XCSITE100 Stimulator Sham
Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
Device: XCSITE100 Stimulator tACS
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.
Device: XCSITE100 Stimulator Sham
The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
Also known as: Sham tACS
Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
Also known as: tACS
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
Time frame: 5 minute recording before and after intervention
| Milestone | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants |
|---|---|---|---|---|
| Started | 21 | 20 | 21 | 22 |
| Completed | 21 | 20 | 21 | 21 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Technical difficulty | 0 | 0 | 0 | 1 |
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
| microvolts | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants |
|---|---|---|---|---|
| Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation | -0.005 ± 0.022 | 0.008 ± 0.023 | 0.004 ± 0.017 | 0.007 ± 0.022 |
Collected over Adverse events were collected over the 5 hours of the single session experiment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alpha Stimulation in Patients in a Depressive Episode | 0/21 (0%) | 0/21 (0%) | 12/21 (57.1%) |
| Sham Stimulation in Patients in a Depressive Episode | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Alpha Stimulation in Healthy Participants | 0/21 (0%) | 0/21 (0%) | 9/21 (42.9%) |
| Sham Stimulation in Healthy Participants | 0/22 (0%) | 0/22 (0%) | 5/22 (22.7%) |
| Event | Alpha Stimulation in Patients in a Depressive Episode | Sham Stimulation in Patients in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants |
|---|---|---|---|---|
| TinglingInvestigations | 7/21 | 2/20 | 7/21 | 4/22 |
| Burning sensationInvestigations | 7/21 | 3/20 | 3/21 | 3/22 |
| Flickering LightsInvestigations | 3/21 | 0/20 | 3/21 | 2/22 |
| ItchingInvestigations | 3/21 | 1/20 | 0/21 | 1/22 |
| Scalp painInvestigations | 3/21 | 0/20 | 1/21 | 2/22 |
| Neck painInvestigations | 0/21 | 1/20 | 0/21 | 0/22 |
| HeadacheInvestigations | 0/21 | 1/20 | 0/21 | 0/22 |
One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
| Age, Continuous(years) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| Mean | 28.429 ± 11.902 | 27.65 ± 12.227 | 28.095 ± 11.432 | 27.182 ± 12.133 | 27.796 ± 11.831 |
| Sex: Female, Male(Participants) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| Female | 17 | 16 | 17 | 17 | 67 |
| Male | 4 | 4 | 4 | 5 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 6 | 2 | 9 |
| Not Hispanic or Latino | 20 | 19 | 14 | 17 | 70 |
| Unknown or Not Reported | 1 | 0 | 1 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 4 | 7 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 2 | 4 | 12 |
| White | 15 | 16 | 13 | 10 | 54 |
| More than one race | 1 | 1 | 2 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| United States | 21 | 20 | 21 | 22 | 84 |
| Alpha oscillations in left frontal cortex before stimulation(microvolts) | Alpha Stimulation in Participants in a Depressive Episode | Sham Stimulation in Participants in a Depressive Episode | Alpha Stimulation in Healthy Participants | Sham Stimulation in Healthy Participants | Total |
|---|---|---|---|---|---|
| Mean | 0.789 ± 0.088 | 0.812 ± 0.056 | 0.826 ± 0.076 | 0.845 ± 0.095 | 0.818 ± 0.081 |
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