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Completed

NCT Number: NCT02339285

Transcranial Alternating Current Stimulation for Major Depressive Disorder

Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill Medical School Wing C

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tACS (alpha)

Device

tACS (gamma)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pilot Clinical Trial for the Evaluation of Feedback Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder

Acronym: MDD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2015
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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