Single Session of tACS in a Depressive Episode

NCT03449979 | Completed Results FDA Device

• 2 other identifiers: 16-1911bR01MH101547
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

tACS; transcranial alternating current stimulation; stimulation; heart rate variability; electroencephalogram; EEG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

alpha stimulation in participants in a depressive episode

EXPERIMENTAL

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.

Device: XCSITE100 Stimulator tACS

sham stimulation in participants in a depressive episode

PLACEBO COMPARATOR

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.

Device: XCSITE100 Stimulator Sham

alpha stimulation in healthy participants

EXPERIMENTAL

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.

Device: XCSITE100 Stimulator tACS

sham stimulation in healthy participants

PLACEBO COMPARATOR

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.

Device: XCSITE100 Stimulator Sham

Interventions

XCSITE100 Stimulator Sham 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.

Also known as: Sham tACS

sham stimulation in healthy participants; sham stimulation in participants in a depressive episode

XCSITE100 Stimulator tACS 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.

Also known as: tACS

alpha stimulation in healthy participants; alpha stimulation in participants in a depressive episode

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Justin Riddle, PhD
• Organization: University of North Carolina at Chapel Hill

justin_riddle@med.unc.edu

6617131602

Study Officials

• Flavio Frohlich, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study recruits both participants 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 10 Hz and the other half receiving placebo (or sham) stimulation.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 28, 2018
• Study Start: September 19, 2018
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)