N/A
N=20
Mechanism of Action of tACS for the Treatment of MDD
Major Depressive Disorder · MDD
Bottom Line
View on ClinicalTrials.gov: NCT03994081 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in the Amplitude of Left Frontal Alpha Oscillations Measured Durin Resting-state EEG Recordings From Baseline to Day 5 of Stimulation. — 0.042; 0.169 microvolts^2/Hz — p=0.332
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tACS (Device); Sham tACS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Amplitude of Left Frontal Alpha Oscillations Measured Durin Resting-state EEG Recordings From Baseline to Day 5 of Stimulation. |
0.042; 0.169 | 0.332 |
| PRIMARY Change in the Amplitude of Left Frontal Alpha Oscillations Measured During Resting-state EEG Recordings From Baseline to Two-week Follow-up of Stimulation. |
-0.016; 0.012 | 0.790 |
| SECONDARY Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Day 5 of Intervention and Changes in Symptoms of Depression. |
-0.263; -0.109 | 0.464 |
| SECONDARY Correlation Between Changes in the Amplitude of Left Frontal Alpha Oscillations From Baseline to Two-week Follow-up and Depression Symptoms. |
0.624; 0.087 | 0.072 |
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 EEG) and mood in patients with Major Depressive Disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Ages 18-70 years
- DSM-IV diagnosis of MDD; unipolar, non-psychotic
- Hamilton Rating Depression Rating Scale (HRDS-17) score >8
- Low suicide risk as determined by a score of <3 on the Suicide Item on the HDRS-17 and based on additional information from the C-SSRS (no intent)
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Exclusion Criteria
- DSM-V diagnosis of moderate or severe alcohol use disorder (AUD) within the last 12 months.
- DSM-V diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 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)
- Change of ADHD medication within the last 4 weeks.
- Change of benzodiazepines or anti-epileptic medication within the last 4 weeks
- Antidepressant drugs taken for less than 4 weeks (i.e., recently initiated)
- 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 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; comorbid neurological condition (i.e. seizure disorder, brain tumor)
- History of traumatic brain injury that required subsequent cognitive rehabilitation, or cause cognitive sequelae.
- Prior brain surgery and/or any brain devices/implants, including cochlear implants and aneurysm clips
- Current pregnancy or lactation. If the ability to become pregnant exists, unwillingness to use appropriate birth control measures during study participation
- 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
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT03994081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.