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出境医 / 临床实验 / Mechanism of Action of tACS for the Treatment of MDD (GLADIATOR 2)

Mechanism of Action of tACS for the Treatment of MDD (GLADIATOR 2)

Study Description
Brief Summary:
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD), and to determine specific ways that tACS may affect symptoms in depression, specifically sleep, hedonic tendencies, and cognition.

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

Detailed Description:

Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces cortical hyperactivity and causes a clinical improvement.

Aim 1: To investigate the physiological changes in patients with MDD over the course of a 5-day, 40 minute stimulation protocol, specifically changes in alpha oscillation power from resting state EEG recordings over the course of the intervention (baseline to Day 5 of stimulation, to both follow-up visits).

Aim 2: To elucidate the relationship between changes in EEG and changes in depressive symptoms, by comparing the changes in clinical assessments (e.g., MADRS) and the change in alpha oscillation power over the course of the intervention (baseline to day 5 of stimulation, to both follow-up visits).

Study Design
Layout table for study information
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)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Change in Alpha Oscillation Power from Resting State EEG Recordings from Baseline to Day 5 of Stimulation [ Time Frame: Baseline (Day 1) to Day 5 of Stimulation ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and before stimulation on Day 5 of stimulation

  2. Change in Alpha Oscillation Power from Resting State EEG Recordings From Baseline to 2 Week Follow-Up [ Time Frame: Baseline (Day 1) to 2 Week Follow-Up ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and at the 2 Week Follow-Up

  3. Change in Alpha Oscillation Power from Resting State EEG Recordings from Baseline to 4 Week Follow-Up [ Time Frame: Baseline (Day 1) to 4 Week Follow-Up ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and at the 4 Week Follow-Up


Secondary Outcome Measures :
  1. Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to Day 5 Simulation [ Time Frame: Baseline (Day 1) to Day 5 of Stimulation ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and Day 5 of stimulation. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and Day 5. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and Day 5 before stimulation.

  2. Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to 2 Week Follow-Up [ Time Frame: Baseline (Day 1) to 2 Week Follow-Up ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and at the 2 Week Follow-Up. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and at the 2 Week Follow-Up. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and at the 2 Week Follow-Up.

  3. Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to 4 Week Follow-Up [ Time Frame: Baseline (Day 1) to 4 Week Follow-Up ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and at the 4 Week Follow-Up. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and at the 4 Week Follow-Up. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and at the 4 Week Follow-Up.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rachel Force, PhD 919-966-9929 rachel_force@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Rachel Force, PhD    919-966-9929    rachel_force@med.unc.edu   
Principal Investigator: Flavio Frohlich, PhD         
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
Layout table for investigator information
Principal Investigator: Flavio Frohlich, PhD University of North Carolina at Chapel Hill - Department of Psychiatry
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date January 19, 2021
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Change in Alpha Oscillation Power from Resting State EEG Recordings from Baseline to Day 5 of Stimulation [ Time Frame: Baseline (Day 1) to Day 5 of Stimulation ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and before stimulation on Day 5 of stimulation
  • Change in Alpha Oscillation Power from Resting State EEG Recordings From Baseline to 2 Week Follow-Up [ Time Frame: Baseline (Day 1) to 2 Week Follow-Up ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and at the 2 Week Follow-Up
  • Change in Alpha Oscillation Power from Resting State EEG Recordings from Baseline to 4 Week Follow-Up [ Time Frame: Baseline (Day 1) to 4 Week Follow-Up ]
    Change in the EEG power in the alpha (8-12Hz) band before stimulation on Day 1 and at the 4 Week Follow-Up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to Day 5 Simulation [ Time Frame: Baseline (Day 1) to Day 5 of Stimulation ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and Day 5 of stimulation. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and Day 5. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and Day 5 before stimulation.
  • Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to 2 Week Follow-Up [ Time Frame: Baseline (Day 1) to 2 Week Follow-Up ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and at the 2 Week Follow-Up. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and at the 2 Week Follow-Up. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and at the 2 Week Follow-Up.
  • Correlation Coefficient (r) Between Changes in Resting State EEG and Changes in Depressive Symptoms From Baseline to 4 Week Follow-Up [ Time Frame: Baseline (Day 1) to 4 Week Follow-Up ]
    Correlation Coefficient (r) will be used to determine if there is a relationship between the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores and change in alpha power before stimulation on Day 1 and at the 4 Week Follow-Up. The MADRS is a clinician-rated measure of depression severity with a total score ranging from 0 to 60, where higher scores indicate greater depression severity. The change in MADRS score will be calculated by taking the difference between MADRS scores before stimulation on Day 1 and at the 4 Week Follow-Up. This change score will be correlated with the change in EEG power within the alpha (8-12 Hz) band. The change in alpha EEG power will be calculated by taking the mean decibel (dB) change between Day 1 and at the 4 Week Follow-Up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanism of Action of tACS for the Treatment of MDD
Official Title  ICMJE Mechanism of Action for Transcranial Alternating Current (tACS) Stimulation for the Treatment of Major Depressive Disorder (MDD)
Brief Summary Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD), and to determine specific ways that tACS may affect symptoms in depression, specifically sleep, hedonic tendencies, and cognition.
Detailed Description

Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces cortical hyperactivity and causes a clinical improvement.

Aim 1: To investigate the physiological changes in patients with MDD over the course of a 5-day, 40 minute stimulation protocol, specifically changes in alpha oscillation power from resting state EEG recordings over the course of the intervention (baseline to Day 5 of stimulation, to both follow-up visits).

Aim 2: To elucidate the relationship between changes in EEG and changes in depressive symptoms, by comparing the changes in clinical assessments (e.g., MADRS) and the change in alpha oscillation power over the course of the intervention (baseline to day 5 of stimulation, to both follow-up visits).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • MDD
Intervention  ICMJE
  • Device: tACS
    XCSITE100
  • Device: Sham tACS
    XCSITE100
Study Arms  ICMJE
  • Experimental: transcranial alternating current stimulation (tACS) at alpha
    10 Hz tACS with an amplitude of 1 mA for 40 minutes. Uses tACS device.
    Intervention: Device: tACS
  • 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.
    Intervention: Device: Sham tACS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Force, PhD 919-966-9929 rachel_force@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994081
Other Study ID Numbers  ICMJE 20-1822
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Foundation of Hope for Research and Treatment of Mental Illness
  • National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: Flavio Frohlich, PhD University of North Carolina at Chapel Hill - Department of Psychiatry
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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