Clinical trial NCT02339285: Transcranial Alternating Current Stimulation for Major Depressive Disorder
Official title: Pilot Clinical Trial for the Evaluation of Feedback Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
MDD
Keywords: tACS
Major Depressive Disorder
MDD
mood symptoms
sham
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-01-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline to F2 (4 weeks after completion of the intervention)
Secondary outcomes:
measure: Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation
timeFrame: Baseline to Day 5 of Stimulation
measure: Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention
timeFrame: Baseline to F2
Other outcomes:
measure: Change in Hamilton Depression Rating Scale (HDRS) Score
timeFrame: Baseline to Day 5 of Stimulation; Baseline to F2
measure: Change in Montreal Cognitive Assessment (MoCA) Score
timeFrame: Baseline to F2
measure: Change in Beck Depression Inventory (BDI) Score
timeFrame: Baseline to Day 5; Baseline to F2
measure: Clinical Global Impressions (CGI) Raw Score
timeFrame: Day 5; F2 (4 weeks after completion of treatment)
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Medical School Wing C
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill, Department of Psychiatry
name: Flavio Frohlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valiengo L, Bensenor IM, Goulart AC, de Oliveira JF, Zanao TA, Boggio PS, Lotufo PA, Fregni F, Brunoni AR. The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. Depress Anxiety. 2013 Jul;30(7):646-53. doi: 10.1002/da.22079. Epub 2013 Apr 26.