Transcranial Alternating Current Stimulation for Major Depressive Disorder (MDD)
July 17, 2018 updated by: University of North Carolina, Chapel Hill
Pilot Clinical Trial for the Evaluation of Feedback Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces cortical hyperactivity and causes a clinical improvement
Aim 1: To conduct a pilot clinical trial to establish feasibility and to collect first effectiveness data for the use of tACS to renormalize pathological alpha oscillations in the dorsolateral prefrontal cortex (dl-pfc) of unmedicated patients with MDD by comparing MADRS scores from baseline and one month follow up.
Aim 2: Compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. Collect EEG data at the one month follow up visit using this data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
Study Type
Interventional
Enrollment (Actual)
32
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 Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Chapel Hill Medical School Wing C
-
-
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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, 18-65 years old
- Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) diagnosis of MDD; unipolar, non-psychotic
- Hamilton Depression Rating Scale score >8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Meet criteria for low suicide risk
- Willing to comply with all study procedures and be available to do so for the duration of the study
- Women of reproductive potential must use highly effective contraception
Exclusion Criteria:
- DSM-IV 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 use of benzodiazepines or anti-epileptic drugs
- 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 ECT induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurism
- 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
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: tACS (alpha)
10 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes.
Uses tACS (alpha) device.
|
|
|
EXPERIMENTAL: tACS (gamma)
40 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes.
Uses tACS (gamma) device.
|
|
|
SHAM_COMPARATOR: Sham stimulation
Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation.
Uses tACS (alpha) device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time Frame: Baseline to F2 (4 weeks after completion of the intervention)
|
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6.
The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2).
A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline).
In these results, negative values will indicate a decrease in depressive symptoms.
|
Baseline to F2 (4 weeks after completion of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation
Time Frame: Baseline to Day 5 of Stimulation
|
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation.
The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2).
The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
|
Baseline to Day 5 of Stimulation
|
|
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention
Time Frame: Baseline to F2
|
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention.
The investigators will also collect EEG on the fifth day of stimulation.
The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
|
Baseline to F2
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HDRS) Score
Time Frame: Baseline to Day 5 of Stimulation; Baseline to F2
|
The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54.
A higher score indicates a worse outcome.
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2).
The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms.
|
Baseline to Day 5 of Stimulation; Baseline to F2
|
|
Change in Montreal Cognitive Assessment (MoCA) Score
Time Frame: Baseline to F2
|
This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2).
Total score ranges from 0 to 30, with higher values indicating better cognition.
The investigators will compare the scores between baseline and F2.
Reported values are the raw change (increase or decrease) from baseline.
|
Baseline to F2
|
|
Change in Beck Depression Inventory (BDI) Score
Time Frame: Baseline to Day 5; Baseline to F2
|
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2).
Higher scores indicate more depressive symptoms.
Total score is out of 63 possible.
The investigators will compare the scores between baseline and F2.
In these results, negative values indicate a decrease in depressive symptoms.
|
Baseline to Day 5; Baseline to F2
|
|
Clinical Global Impressions (CGI) Raw Score
Time Frame: Day 5; F2 (4 weeks after completion of treatment)
|
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2).
The investigators will compare the scores between baseline and F2.The reported values are from Item 1 "Severity of Illness" on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients.
|
Day 5; F2 (4 weeks after completion of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Flavio Frohlich, PhD, University of North Carolina at Chapel Hill, Department of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 7, 2015
Primary Completion (ACTUAL)
June 19, 2017
Study Completion (ACTUAL)
June 19, 2017
Study Registration Dates
First Submitted
January 12, 2015
First Submitted That Met QC Criteria
January 14, 2015
First Posted (ESTIMATE)
January 15, 2015
Study Record Updates
Last Update Posted (ACTUAL)
August 20, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-1622
- 5R01MH101547-02 (NIH)
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.