Mechanism of Action of tACS for the Treatment of MDD

NCT ID: NCT03994081

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2023-06-02

Brief Summary

The purpose of this research study is to use a specific type of non-invasive brain stimulation known as transcranial alternating current stimulation (tACS) to determine its effects on brain activity (measured with EEG) and mood in patients with Major Depressive Disorder (MDD).

Detailed Description

The device used for non-invasive brain stimulation is investigational and has not been approved by the FDA, though it has been designated as a nonsignificant risk (NSR) device study by the FDA. Half of the participants will receive tACS and half will receive sham stimulation, an inactive control procedure for comparison use only. Participation in this study includes up to eight appointments, each one lasting from 30 minutes to four hours over the course of 3 weeks. The first two appointments will be remote interviews to determine eligibility. If the subjects qualify, the next five appointments will be scheduled as consecutive stimulation sessions in the Carolina Center for Neurostimulation at the Vilcom office. The follow-up appointment will be in our center two weeks after the completion of the stimulation sessions. We estimate the total time needed to complete study participation to be about 17 hours.

Conditions

Major Depressive Disorder; MDD

Study Design

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

Study Groups

alpha Transcranial alternating current stimulation (tACS).

10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes.

Group Type: EXPERIMENTAL

tACS

Intervention Type: DEVICE

XCSITE100

Sham stimulation

20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation.

Group Type: SHAM_COMPARATOR

Sham tACS

Intervention Type: DEVICE

XCSITE100

Interventions

tACS

XCSITE100

Intervention Type: DEVICE

Sham tACS

XCSITE100

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 18-70 years
• DSM-IV diagnosis of MDD; unipolar, non-psychotic
• Hamilton Rating Depression Rating Scale (HRDS-17) score >8
• Low suicide risk as determined by a score of <3 on the Suicide Item on the HDRS-17 and based on additional information from the C-SSRS (no intent)
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Exclusion Criteria

• DSM-V diagnosis of moderate or severe alcohol use disorder (AUD) within the last 12 months.
• DSM-V diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
• Current axis I mood, or psychotic disorder other than major depressive disorder
• Lifetime comorbid psychiatric bipolar or psychotic disorder
• Eating disorder (current or within the past 6 months)
• Obsessive-compulsive disorder (lifetime)
• Post-traumatic stress disorder (PTSD, current or within the last 6 months)
• Change of ADHD medication within the last 4 weeks.
• Change of benzodiazepines or anti-epileptic medication within the last 4 weeks
• Antidepressant drugs taken for less than 4 weeks (i.e., recently initiated)
• Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and 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; comorbid neurological condition (i.e. seizure disorder, brain tumor)
• History of traumatic brain injury that required subsequent cognitive rehabilitation, or cause cognitive sequelae.
• Prior brain surgery and/or any brain devices/implants, including cochlear implants and aneurysm clips
• Current pregnancy or lactation. If the ability to become pregnant exists, unwillingness to use appropriate birth control measures during study participation
• 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
• Non-English speakers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation of Hope, North Carolina

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rubinow, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill - Department of Psychiatry

Locations

UNC at Vilcom Center

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-1822

Identifier Type: -

Identifier Source: org_study_id