Depression Clinical Trial
— SSDEOfficial title:
Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)
Verified date | September 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 84 |
Est. completion date | August 16, 2019 |
Est. primary completion date | August 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 minute recording before and after intervention |
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