Mechanism of Action of tACS for the Treatment of MDD

NCT03994081 | Completed Results FDA Device

• 1 other identifier: 20-1822
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder; MDD

Keywords

tACS; Major Depressive Disorder; MDD; mood symptoms; sham

Outcome Measures

Primary Outcomes (2)

• Change in the Amplitude of Left Frontal Alpha Oscillations Measured Durin Resting-state EEG Recordings From Baseline to Day 5 of Stimulation.

  Fourier transform is applied to 2 second epochs of resting-state EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes. The difference between the baseline recording on the first day of stimulation is compared to the recording on the fifth day of the intervention prior to stimulation.

  Baseline, Day 5

• Change in the Amplitude of Left Frontal Alpha Oscillations Measured During Resting-state EEG Recordings From Baseline to Two-week Follow-up of Stimulation.

  Fourier transform is applied to 2 second epochs of resting-state EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes. The difference between the baseline recording on the first day of stimulation is compared to the recording on the two-week follow-up after intervention.

  Baseline, two-week follow-up visit

Secondary Outcomes (2)

• Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Day 5 of Intervention and Changes in Symptoms of Depression.

  Baseline, Day 5

• Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Two-week Follow-up and Depression Symptoms.

  Baseline, two-week follow-up visit

Study Arms (2)

alpha Transcranial alternating current stimulation (tACS).

EXPERIMENTAL

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

Device: tACS

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham tACS

Interventions

tACS DEVICE

XCSITE100

alpha Transcranial alternating current stimulation (tACS).

Sham tACS DEVICE

XCSITE100

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

UNC at Vilcom Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Tobias Schwippel, MD
• Organization: University of North Carolina at Chapel Hill

tobias_schwippel@unc.edu

919-966-9929

Study Officials

• David Rubinow, MD

  University of North Carolina at Chapel Hill - Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Using sham stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 21, 2019
• Study Start: June 9, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be available starting from 9 to 36 months following publication.
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (1)