N/A
N=84
Single Session of tACS in a Depressive Episode
Depression · Major Depressive Disorder · Premenstrual Dysphoric Disorder · Depressive Episode
Bottom Line
View on ClinicalTrials.gov: NCT03449979 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation — -0.005; 0.008; 0.004; 0.007 microvolts — p=0.0852
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XCSITE100 Stimulator Sham (Device); XCSITE100 Stimulator tACS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation |
-0.005; 0.008; 0.004; 0.007 | 0.0852 |
Summary
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).
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
Data sourced from ClinicalTrials.gov (NCT03449979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.