Transcranial Alternating Current Stimulation for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— MDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339285
• Other study ID #: 14-1622
• Secondary ID: 5R01MH101547-02
• Status: Completed
• Phase: N/A
• Start date: May 7, 2015
• Est. completion date: June 19, 2017

Study information

• Verified date: January 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• MDD

Intervention

Device:
• tACS (alpha)

• tACS (gamma)

Locations

Country	Name	City	State
United States	UNC Chapel Hill Medical School Wing C	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Valiengo L, Benseñor 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hamilton Depression Rating Scale (HDRS) Score	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
Other	Change in Montreal Cognitive Assessment (MoCA) Score	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
Other	Change in Beck Depression Inventory (BDI) Score	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
Other	Clinical Global Impressions (CGI) Raw Score	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)
Primary	Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score	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	Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day 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
Secondary	Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention	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