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Single Session of tACS in a Depressive Episode (SSDE)

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ClinicalTrials.gov Identifier: NCT03449979
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders.

Participants: 30 males and females, ages 18-65, with depressed mood; 30 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, 2mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).


Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Premenstrual Dysphoric Disorder Depressive Episode Device: XCSITE100 Stimulator Sham Device: XCSITE100 Stimulator tACS Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study recruits both patients currently experiencing a depressive episode (regardless of diagnosis) and those with no history of neurological or psychiatric illness. Randomization will occur in a 1:1 ratio for both of these groups, with half of each group receiving transcranial alternating current stimulation (tACS) at 10Hz and the other half receiving placebo (or sham) stimulation.
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.
Primary Purpose: Basic Science
Official Title: Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)
Actual Study Start Date : September 19, 2018
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : August 16, 2019


Arm Intervention/treatment
Experimental: alpha stimulation
Participants will receive 2mA 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
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.
Other Name: tACS

Placebo Comparator: sham stimulation
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation 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.
Other Name: Sham tACS




Primary Outcome Measures :
  1. Electroencephalogram power in alpha band [ Time Frame: 5 minute recordings before and after the 40 minute stimulation session during a single study visit. ]
    Changes in the EEG power in the alpha (8-12 Hz) band before and after the stimulation session



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449979


Locations
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United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Flavio Frohlich, PhD UNC Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03449979     History of Changes
Other Study ID Numbers: 16-1911b
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of North Carolina, Chapel Hill:
tACS
transcranial alternating current stimulation
stimulation
heart rate variability
electroencephalogram
EEG
Additional relevant MeSH terms:
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Disease
Premenstrual Dysphoric Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Premenstrual Syndrome
Menstruation Disturbances