Single Session of tACS in a Depressive Episode (SSDE)
Depression, Major Depressive Disorder, Premenstrual Dysphoric Disorder
About this trial
This is an interventional basic science trial for Depression focused on measuring tACS, transcranial alternating current stimulation, stimulation, heart rate variability, electroencephalogram, EEG
Eligibility Criteria
Inclusion Criteria for individuals with depressed mood:
- Ages 18-65 years
- Hamilton Depression Rating Scale score >8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale.
- Negative pregnancy test for female participants
Exclusion Criteria for individuals with depressed mood:
- DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months
- DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months
- DSM-5 diagnosis of personality disorder
- Eating disorder (current or within the past 3 months)
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
- Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electro-convulsive therapy (ECT) induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm.
- Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
- History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
- Use of illicit drugs, confirmed by a drug test
- Non English speakers
- Pregnant or nursing females
- Current use of benzodiazepines or anti-epileptic drugs
Inclusion Criteria for healthy controls:
- Ages 18-65 years
- Hamilton Depression Rating Scale score ≤8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Negative pregnancy test for female participants
Exclusion Criteria for healthy controls:
- History of major neurological or psychiatric illness, including epilepsy
- Medication use associated with neurological or psychiatric illnesses
- Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
- DSM-5 diagnosis of personality disorder
- First degree relative (parent, sibling, child) with major neurological or psychiatric illness
- Prior brain surgery
- Major head injury
- Any brain devices/implants (including cochlear implants and aneurysm clips)
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Use of illicit drugs, confirmed by a drug test
- Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
- Skin allergies or very sensitive skin
- Non English speakers
- Pregnant or nursing females
Sites / Locations
- University of North Carolina Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
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
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.
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.
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.
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.