Major Depressive DisorderGLADIATOR2NCT03994081
Mechanism of Action of tACS for the Treatment of MDD
A study testing tACS in people with Major Depressive Disorder and MDD, run by University of North Carolina, Chapel Hill at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, MDD
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC at Vilcom Center
Chapel Hill, North Carolina, 27514
About this study
Official title: 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).
Read the 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
- Being tested
- tACS, Sham tACS
- Keywords
- tACS, Major Depressive Disorder, MDD, mood symptoms, sham
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
XCSITE100
Sham tACSDevice
XCSITE100
| Study group | Role | What they receive |
|---|---|---|
| alpha Transcranial alternating current stimulation (tACS). | Experimental | 10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. Receives: 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. Receives: Device: Sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Baseline, Day 5
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.
Measured: Baseline, two-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start9 Jun 2021
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- David Rubinow, MD, Principal investigator, University of North Carolina at Chapel Hill - Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994081
- Sponsor's protocol ID
- 20-1822
- Acronym
- GLADIATOR2
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action for Transcranial Alternating Current (tACS) Stimulation for the Treatment of Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT03994081
- Acronym / sponsor ID
- GLADIATOR2 / 20-1822
- Conditions
- Major Depressive Disorder, MDD
- Keywords
- tACS, Major Depressive Disorder, MDD, mood symptoms, sham
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha Transcranial alternating current stimulation (tACS). | Experimental | Device: tACS10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes. |
| Sham stimulation | Sham comparator | Device: Sham tACS20 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACSXCSITE100 | Device | alpha Transcranial alternating current stimulation (tACS). |
| Sham tACSXCSITE100 | Device | Sham stimulation |
Primary outcome
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.
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.
2 secondary outcomes
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 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rubinow, MD principal investigator
University of North Carolina at Chapel Hill - Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS in people with Major Depressive Disorder and MDD, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.