Mechanism of Action of tACS for the Treatment of MDD

Major Depressive Disorder Clinical Trial

— GLADIATOR2  

Official title:

Mechanism of Action for Transcranial Alternating Current (tACS) Stimulation for the Treatment of Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994081
• Other study ID #: 20-1822
• Status: Completed
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Intervention

Device:
• tACS
XCSITE100
• Sham tACS
XCSITE100

Locations

Country	Name	City	State
United States	UNC at Vilcom Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to day 5 of intervention and changes in symptoms of depression.	Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Hamilton Depression Rating Scale (HDRS) scores from baseline to Day 5 and the two-week follow up and change in the amplitude of left frontal alpha oscillations before stimulation at baseline and Day 5 of stimulation. The HDRS is a clinician-rated measure of depression severity where higher scores indicate greater depression severity. To calculate the amplitude of left frontal alpha oscillations, 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.	Baseline, Day 5
Secondary	Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to two-week follow-up and depression symptoms.	Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Hamilton Depression Rating Scale (HDRS) scores from baseline, Day 5 and to two-week follow up and change in the amplitude of left frontal alpha oscillations before stimulation at baseline and Day 5 of stimulation. The HDRS is a clinician-rated measure of depression severity where higher scores indicate greater depression severity. To calculate the amplitude of left frontal alpha oscillations, 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.	Baseline, two-week follow-up visit
Secondary	Correlation between changes in the amplitude of left frontal alpha oscillations and changes in symptoms of depression from baseline to two-week follow-up	Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Hamilton Depression Rating Scale (HDRS) scores from baseline to Day 5 and two-week follow up and change in the amplitude of left frontal alpha oscillations before stimulation at baseline and two-week follow-up. The HDRS is a clinician-rated measure of depression severity where higher scores indicate greater depression severity. To calculate the amplitude of left frontal alpha oscillations, 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.	Baseline, two-week follow-up visit