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Mechanism of Action of tACS for the Treatment of MDD (GLADIATOR2)

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ClinicalTrials.gov Identifier: NCT03994081
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 28, 2021
Sponsor:
Collaborators:
Foundation of Hope for Research and Treatment of Mental Illness
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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 electroencephalogram, or EEG, a type of non-invasive brain recording) and mood in patients with Major Depressive Disorder (MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder MDD Device: tACS Device: Sham tACS Not Applicable

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 nine appointments, each one lasting from 30 minutes to six hours over the course of 3 weeks. The first two appointments will be remote interviews to determine eligibility. If you qualify, the next five appointments will be scheduled as consecutive stimulation sessions in the Carolina Center for Neurostimulation at the Vilcom office. An optional MRI at UNC may be scheduled afterwards. The follow-up appointment will be in our center two weeks after you complete the final stimulation session. We estimate the total time needed to complete study participation to be about 28 hours. This study is not designed to benefit participants and there is little chance that you will benefit from being in this research study. There is a small chance that you may experience a reduction in the severity of symptoms associated with MDD. Transcranial current stimulation (the application of a very weak electric current across your brain) has been used without reports of any serious side-effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanism of Action for Transcranial Alternating Current (tACS) Stimulation for the Treatment of Major Depressive Disorder (MDD)
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Experimental: transcranial alternating current stimulation (tACS) at alpha
10 Hz tACS with an amplitude of 1 mA for 40 minutes. Uses tACS device.
Device: tACS
XCSITE100

Sham Comparator: sham stimulation
Will include 20 seconds of ramp-up, 40 seconds of 10 Hz tACS at 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation. Uses sham tACS device.
Device: Sham tACS
XCSITE100




Primary Outcome Measures :
  1. Change in the amplitude of left frontal alpha oscillations measured in eyes-open 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 eyes-open 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.

  2. Change in the amplitude of left frontal alpha oscillations measured in eyes-open 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 eyes-open 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.


Secondary Outcome Measures :
  1. Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to day 5 of intervention and changes in symptoms of depression from baseline to two-week follow-up [ 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 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 eyes-open EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes.

  2. Correlation between changes in the amplitude of left frontal alpha oscillations 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 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 eyes-open EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes.

  3. 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 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 eyes-open EEG data and averaged across epochs. The amplitude of alpha oscillations is calculated and averaged across left frontal electrodes.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-65 years
  • DSM-V diagnosis of MDD; unipolar, non-psychotic
  • Hamilton Rating Depression Rating Scale score >8
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent)
  • Low suicide risk

Exclusion Criteria:

  • DSM-V diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 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)
  • Attention Deficit Hyperactivity Disorder (ADHD, currently under treatment)
  • 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
  • Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electroconvulsive therapy (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
  • History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
  • Non English speakers
  • Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
  • Current use of benzodiazepines or anti-epileptic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994081


Contacts
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Contact: Rachel Force, PhD 984-974-6239 rachel_force@med.unc.edu

Locations
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United States, North Carolina
UNC at Vilcom Center Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Rachel B Force    984-974-6239    GLAD2study@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Foundation of Hope for Research and Treatment of Mental Illness
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: David Rubinow, MD University of North Carolina at Chapel Hill - Department of Psychiatry
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03994081    
Other Study ID Numbers: 20-1822
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
tACS
Major Depressive Disorder
MDD
mood symptoms
sham
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms