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

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ClinicalTrials.gov Identifier: NCT03994081
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Foundation of Hope for Research and Treatment of Mental Illness
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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).


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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: Pilot Clinical Trial for the Evaluation of Feedback Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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 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.



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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: Alana K Atkins, BS 919-966-9929 alana_atkins@med.unc.edu

Locations
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United States, North Carolina
UNC Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Morgan Alexander, BS,BA    919-966-4755    morgan_alexander@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
Investigators
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Principal Investigator: Flavio Frohlich, PhD 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     History of Changes
Other Study ID Numbers: 14-1622b
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
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