Single Session of tACS in a Depressive Episode

NCT ID: NCT03449979

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2019-08-16

Brief 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).

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.

Conditions

Depression; Major Depressive Disorder; Premenstrual Dysphoric Disorder; Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

alpha stimulation in participants in a depressive episode

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.

Group Type: EXPERIMENTAL

XCSITE100 Stimulator tACS

Intervention Type: DEVICE

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.

sham stimulation in participants in a depressive episode

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.

Group Type: PLACEBO_COMPARATOR

XCSITE100 Stimulator Sham

Intervention Type: DEVICE

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.

alpha stimulation in healthy participants

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.

Group Type: EXPERIMENTAL

XCSITE100 Stimulator tACS

Intervention Type: DEVICE

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.

sham stimulation in healthy participants

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.

Group Type: PLACEBO_COMPARATOR

XCSITE100 Stimulator Sham

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Sham tACS; tACS

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Frohlich, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH101547

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-1911b

Identifier Type: -

Identifier Source: org_study_id