- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994081
Mechanism of Action of tACS for the Treatment of MDD (GLADIATOR2)
June 6, 2023 updated by: University of North Carolina, Chapel Hill
Mechanism of Action for Transcranial Alternating Current (tACS) Stimulation for the Treatment of Major Depressive Disorder (MDD)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tobias U Schwippel, MD
- Phone Number: 984-974-6239
- Email: tobias_schwippel@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- UNC at Vilcom Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: alpha Transcranial alternating current stimulation (tACS).
10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes.
|
XCSITE100
|
Sham Comparator: 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.
|
XCSITE100
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the amplitude of left frontal alpha oscillations measured durin resting-state EEG recordings from baseline to day 5 of stimulation.
Time Frame: Baseline, Day 5
|
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.
Time Frame: Baseline, two-week follow-up visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to day 5 of intervention and changes in symptoms of depression.
Time Frame: Baseline, Day 5
|
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
|
Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to two-week follow-up and depression symptoms.
Time Frame: Baseline, two-week follow-up visit
|
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
|
Correlation between changes in the amplitude of left frontal alpha oscillations and changes in symptoms of depression from baseline to two-week follow-up
Time Frame: Baseline, two-week follow-up visit
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David Rubinow, MD, University of North Carolina at Chapel Hill - Department of Psychiatry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Actual)
June 2, 2023
Study Completion (Actual)
June 2, 2023
Study Registration Dates
First Submitted
June 10, 2019
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1822
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD will be shared upon request.
IPD Sharing Time Frame
Data will be available starting from 9 to 36 months following publication.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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